Epilepsy
Conditions
Keywords
Partial-onset seizures, retigabine IR, Open Label Extension, GW582892, Epilepsy
Brief summary
The purpose of this Phase III study is to assess the long-term safety, tolerability and efficacy of flexibly dosed retigabine Immediate Release (IR) as adjunctive therapy in adult subjects with partial-onset seizures. In addition, those subjects who successfully completed 20 weeks of adjunctive treatment with retigabine IR in the parent study, RGB113905, and who were thought to have benefitted from treatment will be provided continued access to retigabine IR.
Detailed description
RTG113413 is an open-label, multicentre extension study of RGB113905. This study will enroll adult subjects with partial-onset seizures (POS) who successfully completed 20 weeks of adjunctive treatment with retigabine IR (4-weeks Titration Phase and 16-weeks Flexible Dose Evaluation Phase) in the parent study, RGB113905 and who were thought to have benefitted from the treatment. The Screening Visit (Visit 1) will be performed on the same day as the final visit of the parent study (Visit 7/Week 20). Subjects entering the extension study will initially receive the same dose of retigabine IR and concurrent antiepileptic drug (AED) as they were receiving on the final visit of the parent study. After the first week of the extension study, the subject's retigabine dose can be adjusted based on efficacy and tolerability. The overall daily dose of retigabine IR must be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum). In addition, the dose and the number of concurrent AEDs can be adjusted to meet the individual needs of the subject. Retigabine IR monotherapy is not permitted. If concurrent AED therapy is removed, the subject must be withdrawn from the study. Subjects in this study will be eligible to receive retigabine IR treatment until one of the following criteria have been met: 1) regulatory approval and commercial availability of retigabine IR or 2) retigabine IR is not approved by the regulatory authorities or 3) the study is terminated by the sponsor for reasons including, but not limited to, safety issues or 4) subject is withdrawn or withdraws consent or 5) subject has received retigabine IR treatment for a total of 3 years and options i-iv have not been met. After the Screening Visit, subjects will be required to attend 4 further clinic visits at Weeks 13, 26, 39, and 52 in the first year of the study and a total of 3 clinic visits at approximately 4-monthly intervals during each of the second and third year of study. Upon completion or early withdrawal, subjects will begin a 3-week taper period and then return for a follow-up visit.
Interventions
DRUGRetigabine IR
Flexible dose between 300 mg/day (minimum) and 1200 mg/day (maximum)
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject has successfully completed the 20-weeks (4-weeks Titration and 16-weeks of Flexible Dose Evaluation Phases) of treatment with retigabine IR as adjunctive therapy to one of the pre-specified AEDs in the parent study RGB113905. * The investigator and the subject, or caregiver, if applicable, should consider it beneficial for the subject to receive continued retigabine IR therapy. * The subject is able and willing to maintain an accurate and complete daily written Seizure Calendar or has a caregiver who is able and willing to maintain an accurate and complete daily written Seizure Calendar for the entire duration of the study. * The subject has given written informed consent, or has a legally authorized representative who has given written informed consent, prior to the performance of any study assessments. * A female subject is eligible to enter and participate in the study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre- menarcheal or post menopausal). * A female subject is eligible to enter and participate in the study if she is child-bearing potential and has a negative pregnancy test at Screening, and agrees to use one of the contraceptive methods listed in Appendix 3 of the protocol. * A female subject is eligible to enter and participate in the study if she not pregnant or lactating or planning to become pregnant during the study. * French subjects only: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Exclusion criteria
* Has met any of the withdrawal criteria in the previous RGB113905 study or has clinically significant abnormal clinical laboratory or ECG findings not resolved prior to entry to the open-label extension study. * Is suffering from acute or progressive neurological disease, severe psychiatric disease, or severe mental abnormalities that are likely to interfere with the study objectives. * Has any medical condition that, in the investigator's judgment, is considered to be clinically significant and could potentially affect subject safety or study outcome, including but not limited to: clinically significant cardiac, renal, hepatic condition, or a condition that affects the absorption, distribution, metabolism or excretion of drugs. * Has any abnormality on 12-lead ECG at Screening which is clinically significant in the opinion of the investigator, or has QTc (either QTcB Bazett's correction or QTcF Fridericia's correction) \>500 msec or \>530 msec for subjects with Bundle Branch Block or an increase in QTc of \>60 msec from Baseline in the parent study. * Is unwilling or inability to follow the study procedures or reporting of AEs. * Is planning on following a ketogenic diet or planning surgery or implantation of a Vagus Nerve Stimulator (VNS) to control seizures during the study. Note: Subjects who already have a VNS implanted which is functional may be permitted to enter the study. * Has active suicidal plan/intent or has had active suicidal thoughts in the past 6 months. Has history of suicide attempt in the last 2 years or more than 1 lifetime suicide attempt.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time From Discontinuation of Retigabine to Resolution of All Dermatologist-confirmed Abnormal Discoloration | Up to 2.6 years | Assessments were at approximately 6-monthly intervals (timed relative to the participants previous dermatology assessment) until the abnormal discoloration either resolved or stabilized (as defined by no changes over 2 consecutive 6-monthly assessments performed by the dermatologist over at least 12 months after discontinuation of retigabine). The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa. Only participants with resolution of the specified tissue are included in this analysis. |
| Duration of Retigabine Exposure | Up to 5.8 years | Duration of exposure was calculated from the first dose through the last dose during study including the Taper Phase and presented using median and full range. |
| Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine | Up to 2.6 years | The ophthalmologist/retina specialist determined the presence or absence of retinal and non-retinal ocular abnormalities. Retinal abnormalities included abnormalities in the macula and/or the peripheral retina and non-retinal ocular pigmentary abnormality. |
| Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration After Discontinuation of Retigabine | Up to 2.6 years | Participants who enter the SFUCP who had an on-treatment finding(s) of abnormal discoloration of skin, lips, nails or mucosa confirmed by a dermatologist entered the SFUCP and underwent assessments performed by a dermatologist at 6-monthly intervals. The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa. |
| Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation | Up to 2.6 years | Retinal pigmentary abnormality was determined by either an ophthalmologist or retina specialist. Retinal pigmentary abnormality included abnormality of macula, peripheral retina and unspecified location. If a participant had pigmentary abnormality of macula and pigmentary abnormality of the peripheral retina both should be resolved in order for retinal pigmentary abnormality to be considered resolved. If a participant had non-retinal ocular pigmentary abnormality in more than one location (conjunctiva, sclera, cornea, iris or lens), all should be resolved for non-retinal pigmentary abnormality to be considered resolved. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (TESAEs): Safety Population | Up to 5.8 years | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect or is associated with liver injury or impaired liver function. TEAE refers to an AE for which the onset was on or after the date of the first retigabine dose in this study and on or before 30 days after the last retigabine dose date. AEs that started in the parent study that increased in severity during this study were also considered treatment-emergent. The analysis was performed on Safety Population, which included participants who took at least one dose of study medication after they had enrolled into this OLE study. |
| Number of Participants With AEs and SAEs: All SFUCP Subjects | Up to 2.6 years | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect or is associated with liver injury or impaired liver function. The following AEs were collected in the SFUCP: AEs related to the finding(s) of pigmentation/, discoloration of the eye/skin, AEs related to unexplained vision loss, SAEs, Deaths and Pregnancies. SFUCP collected AEs are those for which onset was 31 days or more after the last dose of retigabine. The analysis was performed on the All SFUCP Subjects population which comprised of all subjects who enter the SFUCP. |
| Number of Participants Withdrawn Due to TEAEs | Up to 5.8 years | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolonged existing hospitalization, results in disability, is a congenital anomaly/birth defect or is associated with liver injury or impaired liver function. TEAE refers to an AE for which the onset was on or after the date of the first retigabine dose and on or before 30 days after the last retigabine dose date. |
| Number of Participants With Retinal Pigmentary Abnormalities | Up to 5.8 years | Number of participants with abnormal findings after eye examination were evaluated. Only retinal pigmentary abnormalities detected on-treatment with retigabine were presented. Retinal pigmentary abnormalities included abnormalities in the macula, peripheral retina and unspecified location. |
| Number of Participants With Pigmentation of Non-retinal Ocular Tissue(s) | Up to 5.8 years | Number of participants with abnormal findings after eye examination were evaluated. Pigmentation of non-retinal ocular tissue (s) detected on-treatment with retigabine were presented. Non-retinal pigmentary abnormalities included abnormalities in the sclera and/ or conjunctiva, cornea, iris and lens. |
| Number of Participants With Abnormal Discoloration of Skin | Up to 5.8 years | Number of participants with Dermatologist-Confirmed abnormal discoloration of skin including skin around the eyes and eyelids, lips, nails, or mucosa were evaluated. Only abnormalities occurring on-treatment with retigabine were presented. |
| Number of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination | Up to 5.8 years | Number of participants with a clinically significant decrease in visual acuity from initial examination were evaluated. Only abnormalities occurring on-treatment with retigabine were presented. |
| Number of Participants With Decrease in Confrontational Visual Field From Initial Examination | Up to 5.8 years | Number of participants with a clinically significant decrease in confrontational visual field from initial examination were evaluated. Only abnormalities occurring on-treatment with retigabine were presented. |
| Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline in Vital Signs and Weight | Up to 5.8 years | Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were measured after at least 5 minutes of rest. Body weight was measured without shoes and wearing light clothing. Baseline assessments in this OLE study were defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Increase or decrease of \>=20 in SBP, increase or decrease of \>=15 in DBP and HR were considered as PCC values. Number of participants with PCC values of vital signs for any visit post-Baseline are presented. |
| Change From Baseline in Electrocardiogram (ECG) Parameter Including HR | Baseline and up to 5.8 years | Single measurements of 12-lead ECG were obtained in supine position after at least 10 minutes of rest using an ECG machine to measure HR. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | Baseline and up to 5.8 years | Single measurements of 12-lead ECG were obtained in supine position after at least 10 minutes of rest using an ECG machine to measure parameters including PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF and RR interval. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Number of Participants With Clinical Chemistry Parameters of PCC | Up to 5.8 years | Number of participants with chemistry parameters of PCC at 'any visit post-Baseline' are presented. Chemistry parameters for which PCC values were identified were alanine aminotransferase (ALT) (if value \>=3 \* upper limit of normal \[ULN\]), alkaline phosphatase (alk.phosphatase) (if value \>=3\*ULN), aspartate aminotransferase (AST) (if value \>=3\*ULN), calcium (if value \<=1.8962 or \>=2.8692), carbon-di-oxide (CO2) (if value \<=18 or \>=36), chloride (if value \<=92 or \>=112), creatine kinase (if value \>=3\*ULN), direct bilirubin (if value \>=1.5\*ULN), glucose (if value \<=2.7755 or \>=11.102), lactate dehydrogenase (LD) (if value \>=3\*ULN), magnesium (if value \<0.36 or \>2.50), potassium (if value \<=3.0 or \>=6.0), sodium (if value \<=127 or \>=153), total bilirubin (if value \>=1.5\*ULN), total protein (if value \<45 or \>100), blood urea nitrogen (BUN) (if value \>=14.28). Only those participants with data available at specific time points were analyzed (represented by n=X in the category titles). |
| Number of Participants With Hematology Parameters of PCC | Up to 5.8 years | Blood samples were collected from participants to evaluate hematology parameters. Number of participants with clinical hematology parameters of PCC at 'any visit post-Baseline' are presented. Hematology parameters for which PCC values were identified were eosinophils (if value is \>0.8), hematocrit (if value is \<=0.32 for males and \<=0.28 for females), platelet count (if value is \<=100 or \>=550), total neutrophils (if value is \<=1.8), white blood cells (WBC) (if value is \<=2.8 or \>=16). Only those participants with data available at specific time points were analyzed (represented by n=X in the category titles). |
| Number of Participants With Urinalysis Parameters of PCC | Up to 5.8 years | Urine samples were collected from participants at specific time points. Number of participants with urinalysis parameters of PCC at 'any visit post-Baseline' are presented. Urinalysis parameters for which PCC values were identified were albumin/creatinine ratio (if value is \>11.3), red blood cells (RBC) (if value is 3-5 or higher), WBC (if value is 5-10 or higher for male and 10-15 or higher for females), specific gravity (if value is \<1.001 or \>1.035) and potential of hydrogen (pH) (if value is \<4.6 or \>8.0). Only those participants with data available at specific time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Albumin and Total Protein | Baseline and up to 5.8 years | Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including albumin and total protein. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Baseline and up to 5.8 years | Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including alk. phosphatase, ALT, AST, creatine kinase and LD. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Baseline and up to 5.8 years | Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including direct bilirubin, total bilirubin and creatinine. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Change From Baseline in BUN/Creatinine Ratio | Baseline and up to 5.8 years | Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including BUN/creatinine ratio. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Baseline and up to 5.8 years | Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including calcium, chloride, CO2, glucose, potassium, magnesium, sodium and BUN. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Baseline and up to 5.8 years | Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including absolute basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet count and WBC count. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Baseline and up to 5.8 years | Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including hemoglobin and MCHC. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Change From Baseline in Hematocrit Levels | Baseline and up to 5.8 years | Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including hematocrit. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Baseline and up to 5.8 years | Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including MCH. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | Baseline and up to 5.8 years | Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including MCV and MPV. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Change From Baseline in RBC Count | Up to 5.8 years | Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including RBC count. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Baseline and up to 5.8 years | Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including percent basophils, eosinophils, lymphocytes, monocytes, neutrophils and RDW. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Change From Baseline in Urine Albumin Creatinine Ratio | Baseline and up to 5.8 years | Urine samples were collected from participants for evaluation of change from Baseline in urinalysis parameters including albumin creatinine ratio. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Change From Baseline in Urine Albumin Levels | Baseline and up to 5.8 years | Urine samples were collected from participants for evaluation of change from Baseline in urinalysis parameters including albumin levels. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Change From Baseline in Urine Creatinine Levels | Baseline and up to 5.8 years | Urine samples were collected from participants for evaluation of change from Baseline in urinalysis parameters including creatinine levels. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Changes From Baseline in American Urological Association Symptom Scale (AUA SS) Score | Baseline and up to 5.8 years | The effect of retigabine on bladder function was assessed using AUA symptom index. It is a 7-item Likert-scored scale ranging from 0 (no symptom at all) to 5 (almost always symptoms present) with a total possible score of 35. AUA SS score is the sum of the responses to these seven questions. The total score for all questions was classified as mild (0 to 7), moderate (8 to 19), or severe (\>19). Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Urine Volume | Baseline and up to 5.8 years | The PVR bladder ultrasound was used to assess urinary retention. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Number of Participants With Suicidal Ideation or Behavior Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score | Up to 5.8 years | Number of participants with suicidal ideation or behavior during treatment were assessed using the C-SSRS score scale. It is a brief questionnaire designed to assess severity and change in suicidality by integrating both behavior and ideation using a semi-structured interview to probe participant responses. Participants are classified with respect to extent of suicidal ideation, extent of suicidal behavior, and with respect to self-injurious behavior. |
| Number of Participants Experiencing New Seizure Types | Up to 5.8 years | Number of participants experiencing new seizure type that is seizure not experienced before were summarized. New seizure types were classified into 5 classes including type A (simple partial seizure), type B (complex partial seizure), type C (Partials, evolving to Secondary Generalized Seizures), type D (Generalized, excluding Myoclonic Seizures), type D2 (Myoclonic Seizures) and type E (Unclassified Seizures). |
| Number of Participants Experiencing Worsening of Seizures | Up to 5.8 years | Worsening of seizures was defined as an increase in seizure frequency or the occurrence of a new, more severe seizure type, or status epilepticus occurring in a participant without a history of status epilepticus. An increase in seizure frequency was defined as doubling of the 28-day seizure frequency compared to the 28-day Baseline seizure frequency established in the parent study. Number of participants experiencing worsening of seizure during study period are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in 28-day Partial-onset Seizure Frequency | Baseline and up to 5.8 years | The seizure frequency was recorded in daily seizure calendar by participants during the treatment period. Percent change from Baseline in 28-day partial onset seizure frequency was presented as mean and standard deviation (SD). Baseline assessments in this OLE study are defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Percent change from Baseline was calculated as post-Baseline value minus Baseline value divided by Baseline value into 100. |
| Number of Participants Experiencing an Increase in 28-day Partial-onset Seizure Frequency From Baseline | Baseline and up to 5.8 years | The seizure frequency was recorded in daily seizure calendar by participants during the treatment period. Baseline assessments in this OLE study are defined by and taken directly from the Baseline assessments in the parent study NCT01336621. |
| Number of Participants Who Remained Seizure-free | Up to 5.8 years | The seizure frequency was recorded in daily seizure calendar by participants during the treatment period. Number of participants who were treated retigabine for at least 6 months and who remained seizure free for any 6 continuous months as well as number of participants who were treated with retigabine for at least 12 months and who remained seizure free for any 12 continuous months are presented. |
| Number of Participants Experiencing a 0 to <25, 25 to <50, 50 to <75 and 75 to 100 Percent Reduction in 28 Day POS Frequency From Baseline | Baseline and up to 5.8 years | The seizure frequency was recorded in daily seizure calendar by participants during the treatment period. Baseline assessments in this OLE study are defined by and taken directly from the Baseline assessments in the parent study NCT01336621. |
Countries
Belgium, Bulgaria, France, Germany, Italy, Netherlands, Poland, Russia, Thailand, Ukraine
Participant flow
Recruitment details
Participants with partial-onset seizures (POS) who successfully completed the 20 weeks of treatment in parent study NCT01336621 were recruited in this open-label extension (OLE) study. The study was conducted in two periods, a primary treatment phase and a safety follow-up continuation phase (SFUCP).
Pre-assignment details
Screening was performed on the same day as the final visit of the parent study NCT01336621. A total of 98 participants completed the parent study and opted to enter into this study. All participants received at least one dose of retigabine immediate release (IR) tablets.
Participants by arm
| Arm | Count |
|---|---|
| Retigabine IR Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum). | 98 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Primary Reporting Phase (Upto 5.8 Years) | Adverse Event | 11 |
| Primary Reporting Phase (Upto 5.8 Years) | Lack of Efficacy | 2 |
| Primary Reporting Phase (Upto 5.8 Years) | Other: Continued in SFUCP | 9 |
| Primary Reporting Phase (Upto 5.8 Years) | Other: lost to follow up | 2 |
| Primary Reporting Phase (Upto 5.8 Years) | Other: Reached stopping criteria | 22 |
| Primary Reporting Phase (Upto 5.8 Years) | Other: study terminated | 11 |
| Primary Reporting Phase (Upto 5.8 Years) | Physician Decision | 2 |
| Primary Reporting Phase (Upto 5.8 Years) | Protocol Violation | 12 |
| Primary Reporting Phase (Upto 5.8 Years) | Withdrawal by Subject | 27 |
| SFUCP (up to 2.6 Years) | Adverse Event | 1 |
| SFUCP (up to 2.6 Years) | Other: Reached stopping criteria | 1 |
| SFUCP (up to 2.6 Years) | Other: Study closed/terminated | 3 |
| SFUCP (up to 2.6 Years) | Physician Decision | 1 |
| SFUCP (up to 2.6 Years) | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Retigabine IR |
|---|---|
| Age, Continuous | 39.2 Years STANDARD_DEVIATION 13.19 |
| Race/Ethnicity, Customized Race customized Asian: South East Asian Heritage | 8 Participants |
| Race/Ethnicity, Customized Race customized White- White/Caucasian/ European Heritage | 90 Participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 98 | 0 / 9 |
| other Total, other adverse events | 38 / 98 | 3 / 9 |
| serious Total, serious adverse events | 4 / 98 | 1 / 9 |
Outcome results
Primary
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count
Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including absolute basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet count and WBC count. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline and up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Monocytes; visit 14 (Week 208); n= 10 | -0.090 Giga cells per liter (GI/L) | Standard Deviation 0.2821 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Platelet count; withdrawal visit; n= 79 | 8.9 Giga cells per liter (GI/L) | Standard Deviation 43.88 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Basophils; visit 1 (Screening); n= 84 | -0.001 Giga cells per liter (GI/L) | Standard Deviation 0.0203 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Basophils; visit 2 (Week 13); n= 85 | -0.005 Giga cells per liter (GI/L) | Standard Deviation 0.0159 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Basophils; visit 3 (Week 26); n= 71 | -0.003 Giga cells per liter (GI/L) | Standard Deviation 0.0197 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Basophils; visit 4 (Week 39); n= 65 | 0.001 Giga cells per liter (GI/L) | Standard Deviation 0.0231 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Basophils; visit 5 (Week 52); n= 60 | 0.002 Giga cells per liter (GI/L) | Standard Deviation 0.017 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Basophils; visit 6 (Week 69); n= 58 | -0.002 Giga cells per liter (GI/L) | Standard Deviation 0.0202 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Basophils; visit 7 (Week 86); n= 53 | -0.002 Giga cells per liter (GI/L) | Standard Deviation 0.0188 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Basophils; visit 8 (Week 104); n= 36 | 0.003 Giga cells per liter (GI/L) | Standard Deviation 0.0165 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Basophils; visit 9 (Week 121); n= 35 | -0.002 Giga cells per liter (GI/L) | Standard Deviation 0.0183 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Basophils; visit 10 (Week 138); n= 33 | -0.002 Giga cells per liter (GI/L) | Standard Deviation 0.0142 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Basophils; visit 11 (Week 156); n= 29 | -0.001 Giga cells per liter (GI/L) | Standard Deviation 0.0151 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Basophils; visit 12 (Week 173); n= 24 | -0.004 Giga cells per liter (GI/L) | Standard Deviation 0.0125 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Basophils; visit 13 (Week 190); n= 17 | 0.000 Giga cells per liter (GI/L) | Standard Deviation 0.0255 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Basophils; visit 14 (Week 208); n= 10 | -0.004 Giga cells per liter (GI/L) | Standard Deviation 0.0165 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Basophils; visit 15 (Week 225); n= 4 | -0.010 Giga cells per liter (GI/L) | Standard Deviation 0.0115 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Basophils; visit 16 (Week 242); n= 4 | -0.003 Giga cells per liter (GI/L) | Standard Deviation 0.005 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Basophils; visit 17 (Week 260); n= 4 | -0.005 Giga cells per liter (GI/L) | Standard Deviation 0.0129 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Basophils; visit 18 (Week 277); n= 2 | 0.000 Giga cells per liter (GI/L) | Standard Deviation 0 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Basophils; withdrawal visit; n= 78 | 0.001 Giga cells per liter (GI/L) | Standard Deviation 0.0186 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Basophils; follow up visit; n= 56 | -0.008 Giga cells per liter (GI/L) | Standard Deviation 0.019 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Eosinophils; visit 1 (Screening); n= 84 | -0.011 Giga cells per liter (GI/L) | Standard Deviation 0.1103 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Eosinophils; visit 2 (Week 13); n= 85 | -0.018 Giga cells per liter (GI/L) | Standard Deviation 0.2505 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Eosinophils; visit 3 (Week 26); n= 71 | -0.029 Giga cells per liter (GI/L) | Standard Deviation 0.2191 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Eosinophils; visit 4 (Week 39); n= 65 | -0.050 Giga cells per liter (GI/L) | Standard Deviation 0.2523 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Eosinophils; visit 5 (Week 52); n= 60 | -0.065 Giga cells per liter (GI/L) | Standard Deviation 0.3016 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Eosinophils; visit 6 (Week 69); n= 58 | -0.025 Giga cells per liter (GI/L) | Standard Deviation 0.1586 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Eosinophils; visit 7 (Week 86); n= 53 | -0.016 Giga cells per liter (GI/L) | Standard Deviation 0.1585 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Eosinophils; visit 8 (Week 104); n= 36 | -0.020 Giga cells per liter (GI/L) | Standard Deviation 0.1992 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Eosinophils; visit 9 (Week 121); n= 35 | -0.015 Giga cells per liter (GI/L) | Standard Deviation 0.1721 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Eosinophils; visit 10 (Week 138); n= 33 | -0.052 Giga cells per liter (GI/L) | Standard Deviation 0.1918 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Eosinophils; visit 11 (Week 156); n= 29 | -0.046 Giga cells per liter (GI/L) | Standard Deviation 0.1846 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Eosinophils; visit 12 (Week 173); n= 24 | -0.065 Giga cells per liter (GI/L) | Standard Deviation 0.3068 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Eosinophils; visit 13 (Week 190); n= 17 | -0.104 Giga cells per liter (GI/L) | Standard Deviation 0.3376 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Eosinophils; visit 14 (Week 208); n= 10 | -0.158 Giga cells per liter (GI/L) | Standard Deviation 0.1591 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Eosinophils; visit 15 (Week 225); n= 4 | -0.140 Giga cells per liter (GI/L) | Standard Deviation 0.0589 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Eosinophils; visit 16 (Week 242); n= 4 | -0.070 Giga cells per liter (GI/L) | Standard Deviation 0.1131 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Eosinophils; visit 17 (Week 260); n= 4 | -0.055 Giga cells per liter (GI/L) | Standard Deviation 0.085 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Eosinophils; visit 18 (Week 277); n= 2 | 0.005 Giga cells per liter (GI/L) | Standard Deviation 0.0636 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Eosinophils; withdrawal visit; n= 78 | -0.056 Giga cells per liter (GI/L) | Standard Deviation 0.2713 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Eosinophils; follow up visit; n= 56 | -0.091 Giga cells per liter (GI/L) | Standard Deviation 0.3022 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Lymphocytes; visit 1 (Screening); n= 84 | -0.225 Giga cells per liter (GI/L) | Standard Deviation 0.6631 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Lymphocytes; visit 2 (Week 13); n= 85 | -0.170 Giga cells per liter (GI/L) | Standard Deviation 0.5506 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Lymphocytes; visit 3 (Week 26); n= 71 | -0.133 Giga cells per liter (GI/L) | Standard Deviation 0.6123 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Lymphocytes; visit 4 (Week 39); n= 65 | -0.210 Giga cells per liter (GI/L) | Standard Deviation 0.5412 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Lymphocytes; visit 5 (Week 52); n= 60 | -0.214 Giga cells per liter (GI/L) | Standard Deviation 0.6446 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Lymphocytes; visit 6 (Week 69); n= 58 | -0.178 Giga cells per liter (GI/L) | Standard Deviation 0.5194 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Lymphocytes; visit 7 (Week 86); n= 53 | -0.093 Giga cells per liter (GI/L) | Standard Deviation 0.5793 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Lymphocytes; visit 8 (Week 104); n= 36 | -0.111 Giga cells per liter (GI/L) | Standard Deviation 0.5839 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Lymphocytes; visit 9 (Week 121); n= 35 | 0.008 Giga cells per liter (GI/L) | Standard Deviation 0.8295 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Lymphocytes; visit 10 (Week 138); n= 33 | -0.177 Giga cells per liter (GI/L) | Standard Deviation 0.6622 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Lymphocytes; visit 11 (Week 156); n= 29 | -0.324 Giga cells per liter (GI/L) | Standard Deviation 0.6801 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Lymphocytes; visit 12 (Week 173); n= 24 | -0.226 Giga cells per liter (GI/L) | Standard Deviation 0.572 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Lymphocytes; visit 13 (Week 190); n= 17 | -0.325 Giga cells per liter (GI/L) | Standard Deviation 0.7086 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Lymphocytes; visit 14 (Week 208); n= 10 | -0.354 Giga cells per liter (GI/L) | Standard Deviation 0.6563 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Lymphocytes; visit 15 (Week 225); n= 4 | -0.990 Giga cells per liter (GI/L) | Standard Deviation 0.6633 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Lymphocytes; visit 16 (Week 242); n= 4 | -0.818 Giga cells per liter (GI/L) | Standard Deviation 0.9694 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Lymphocytes; visit 17 (Week 260); n= 4 | -0.993 Giga cells per liter (GI/L) | Standard Deviation 0.72 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Lymphocytes; visit 18 (Week 277); n= 2 | -1.465 Giga cells per liter (GI/L) | Standard Deviation 0.6718 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Lymphocytes; withdrawal visit; n= 78 | -0.153 Giga cells per liter (GI/L) | Standard Deviation 0.6466 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Lymphocytes; follow up visit; n= 56 | -0.081 Giga cells per liter (GI/L) | Standard Deviation 0.7105 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Monocytes; visit 1 (Screening); n= 84 | -0.043 Giga cells per liter (GI/L) | Standard Deviation 0.18 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Monocytes; visit 2 (Week 13); n= 85 | -0.009 Giga cells per liter (GI/L) | Standard Deviation 0.1603 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Monocytes; visit 3 (Week 26); n= 71 | 0.039 Giga cells per liter (GI/L) | Standard Deviation 0.2031 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Monocytes; visit 4 (Week 39); n= 65 | -0.005 Giga cells per liter (GI/L) | Standard Deviation 0.194 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Monocytes; visit 5 (Week 52); n= 60 | -0.006 Giga cells per liter (GI/L) | Standard Deviation 0.1876 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Monocytes; visit 6 (Week 69); n= 58 | 0.018 Giga cells per liter (GI/L) | Standard Deviation 0.1697 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Monocytes; visit 7 (Week 86); n= 53 | 0.055 Giga cells per liter (GI/L) | Standard Deviation 0.2375 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Monocytes; visit 8 (Week 104); n= 36 | -0.032 Giga cells per liter (GI/L) | Standard Deviation 0.1911 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Monocytes; visit 9 (Week 121); n= 35 | 0.023 Giga cells per liter (GI/L) | Standard Deviation 0.1777 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Monocytes; visit 10 (Week 138); n= 33 | 0.005 Giga cells per liter (GI/L) | Standard Deviation 0.1796 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Monocytes; visit 11 (Week 156); n= 29 | -0.028 Giga cells per liter (GI/L) | Standard Deviation 0.1982 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Monocytes; visit 12 (Week 173); n= 24 | -0.032 Giga cells per liter (GI/L) | Standard Deviation 0.1648 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Monocytes; visit 13 (Week 190); n= 17 | -0.078 Giga cells per liter (GI/L) | Standard Deviation 0.2279 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Monocytes; visit 15 (Week 225); n= 4 | -0.037 Giga cells per liter (GI/L) | Standard Deviation 0.045 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Monocytes; visit 16 (Week 242); n= 4 | -0.020 Giga cells per liter (GI/L) | Standard Deviation 0.0829 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Monocytes; visit 17 (Week 260); n= 4 | 0.025 Giga cells per liter (GI/L) | Standard Deviation 0.1173 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Monocytes; visit 18 (Week 277); n= 2 | 0.080 Giga cells per liter (GI/L) | Standard Deviation 0 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Monocytes; withdrawal visit; n= 78 | 0.041 Giga cells per liter (GI/L) | Standard Deviation 0.2417 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Monocytes; follow up visit; n= 56 | -0.021 Giga cells per liter (GI/L) | Standard Deviation 0.2091 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Total neutrophils; visit 1 (Screening); n= 84 | -0.108 Giga cells per liter (GI/L) | Standard Deviation 1.6418 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Total neutrophils; visit 2 (Week 13); n= 85 | -0.354 Giga cells per liter (GI/L) | Standard Deviation 1.4357 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Total neutrophils; visit 3 (Week 26); n= 71 | -0.175 Giga cells per liter (GI/L) | Standard Deviation 1.4304 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Total neutrophils; visit 4 (Week 39); n= 65 | -0.582 Giga cells per liter (GI/L) | Standard Deviation 1.5237 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Total neutrophils; visit 5 (Week 52); n= 60 | 0.165 Giga cells per liter (GI/L) | Standard Deviation 1.9517 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Total neutrophils; visit 6 (Week 69); n= 58 | -0.159 Giga cells per liter (GI/L) | Standard Deviation 1.5356 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Total neutrophils; visit 7 (Week 86); n= 53 | -0.046 Giga cells per liter (GI/L) | Standard Deviation 2.0418 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Total neutrophils; visit 8 (Week 104); n= 36 | -0.403 Giga cells per liter (GI/L) | Standard Deviation 1.5416 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Total neutrophils; visit 9 (Week 121); n= 35 | 0.519 Giga cells per liter (GI/L) | Standard Deviation 1.9016 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Total neutrophils; visit 10 (Week 138); n= 33 | 0.412 Giga cells per liter (GI/L) | Standard Deviation 1.908 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Total neutrophils; visit 11 (Week 156); n= 29 | 0.361 Giga cells per liter (GI/L) | Standard Deviation 1.5062 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Total neutrophils; visit 12 (Week 173); n= 24 | 0.144 Giga cells per liter (GI/L) | Standard Deviation 1.7867 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Total neutrophils; visit 13 (Week 190); n= 17 | 0.669 Giga cells per liter (GI/L) | Standard Deviation 2.6453 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Total neutrophils; visit 14 (Week 208); n= 10 | 0.113 Giga cells per liter (GI/L) | Standard Deviation 1.7471 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Total neutrophils; visit 15 (Week 225); n= 4 | -0.825 Giga cells per liter (GI/L) | Standard Deviation 1.9404 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Total neutrophils; visit 16 (Week 242); n= 4 | -1.183 Giga cells per liter (GI/L) | Standard Deviation 1.9538 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Total neutrophils; visit 17 (Week 260); n= 4 | -0.990 Giga cells per liter (GI/L) | Standard Deviation 2.151 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Total neutrophils; visit 18 (Week 277); n= 2 | -2.210 Giga cells per liter (GI/L) | Standard Deviation 2.6446 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Total neutrophils; withdrawal visit; n= 78 | 0.209 Giga cells per liter (GI/L) | Standard Deviation 1.6761 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Total neutrophils; follow up visit; n= 56 | 0.095 Giga cells per liter (GI/L) | Standard Deviation 1.9626 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Platelet count; visit 1 (Screening); n= 84 | -1.7 Giga cells per liter (GI/L) | Standard Deviation 34.31 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Platelet count; visit 2 (Week 13); n= 88 | 3.7 Giga cells per liter (GI/L) | Standard Deviation 38.83 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Platelet count; visit 3 (Week 26); n= 73 | 5.1 Giga cells per liter (GI/L) | Standard Deviation 44.34 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Platelet count; visit 4 (Week 39); n= 68 | 2.9 Giga cells per liter (GI/L) | Standard Deviation 45.75 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Platelet count; visit 5 (Week 52); n= 63 | 4.1 Giga cells per liter (GI/L) | Standard Deviation 37.72 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Platelet count; visit 6 (Week 69); n= 62 | 6.9 Giga cells per liter (GI/L) | Standard Deviation 39.48 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Platelet count; visit 7 (Week 86); n= 55 | 1.5 Giga cells per liter (GI/L) | Standard Deviation 50.29 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Platelet count; visit 8 (Week 104); n= 41 | 4.5 Giga cells per liter (GI/L) | Standard Deviation 43.95 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Platelet count; visit 9 (Week 121); n= 35 | 8.7 Giga cells per liter (GI/L) | Standard Deviation 45.39 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Platelet count; visit 10 (Week 138); n= 36 | 6.8 Giga cells per liter (GI/L) | Standard Deviation 42.37 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Platelet count; visit 11 (Week 156); n= 31 | 1.9 Giga cells per liter (GI/L) | Standard Deviation 37.92 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Platelet count; visit 12 (Week 173); n= 24 | 9.7 Giga cells per liter (GI/L) | Standard Deviation 37.95 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Platelet count; visit 13 (Week 190); n= 18 | 7.0 Giga cells per liter (GI/L) | Standard Deviation 37.15 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Platelet count; visit 14 (Week 208); n= 10 | 18.9 Giga cells per liter (GI/L) | Standard Deviation 69.95 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Platelet count; visit 15 (Week 225); n= 4 | -31.3 Giga cells per liter (GI/L) | Standard Deviation 11.15 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Platelet count; visit 16 (Week 242); n= 4 | -9.0 Giga cells per liter (GI/L) | Standard Deviation 63.92 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Platelet count; visit 17 (Week 260); n= 4 | -10.0 Giga cells per liter (GI/L) | Standard Deviation 61.6 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Platelet count; visit 18 (Week 277); n= 2 | -19.0 Giga cells per liter (GI/L) | Standard Deviation 100.41 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | Platelet count; follow up visit; n= 58 | 8.9 Giga cells per liter (GI/L) | Standard Deviation 54.58 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | WBC count; visit 1 (Screening); n= 84 | 0.30 Giga cells per liter (GI/L) | Standard Deviation 6.496 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | WBC count; visit 2 (Week 13); n= 78 | -0.46 Giga cells per liter (GI/L) | Standard Deviation 1.512 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | WBC count; visit 3 (Week 26); n= 66 | -0.24 Giga cells per liter (GI/L) | Standard Deviation 1.354 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | WBC count; visit 4 (Week 39); n= 59 | -0.84 Giga cells per liter (GI/L) | Standard Deviation 1.627 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | WBC count; visit 5 (Week 52); n= 54 | -0.05 Giga cells per liter (GI/L) | Standard Deviation 1.989 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | WBC count; visit 6 (Week 69); n= 54 | -0.41 Giga cells per liter (GI/L) | Standard Deviation 1.637 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | WBC count; visit 7 (Week 86); n= 50 | -0.12 Giga cells per liter (GI/L) | Standard Deviation 2.059 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | WBC count; visit 8 (Week 104); n= 33 | -0.51 Giga cells per liter (GI/L) | Standard Deviation 1.666 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | WBC count; visit 9 (Week 121); n= 32 | 0.58 Giga cells per liter (GI/L) | Standard Deviation 1.968 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | WBC count; visit 10 (Week 138); n= 32 | 0.22 Giga cells per liter (GI/L) | Standard Deviation 2.106 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | WBC count; visit 11 (Week 156); n= 27 | 0.09 Giga cells per liter (GI/L) | Standard Deviation 1.805 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | WBC count; visit 12 (Week 173); n= 22 | -0.15 Giga cells per liter (GI/L) | Standard Deviation 1.971 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | WBC count; visit 13 (Week 190); n= 15 | 0.43 Giga cells per liter (GI/L) | Standard Deviation 2.804 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | WBC count; visit 14 (Week 208); n= 10 | -0.49 Giga cells per liter (GI/L) | Standard Deviation 2.247 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | WBC count; visit 15 (Week 225); n= 4 | -2.00 Giga cells per liter (GI/L) | Standard Deviation 2.608 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | WBC count; visit 16 (Week 242); n= 4 | -2.10 Giga cells per liter (GI/L) | Standard Deviation 2.825 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | WBC count; visit 17 (Week 260); n= 4 | -2.03 Giga cells per liter (GI/L) | Standard Deviation 2.941 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | WBC count; visit 18 (Week 277); n= 2 | -3.60 Giga cells per liter (GI/L) | Standard Deviation 3.394 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | WBC count; withdrawal visit; n= 70 | 0.13 Giga cells per liter (GI/L) | Standard Deviation 1.757 |
| Retigabine IR | Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count | WBC count; follow up visit; n= 50 | -0.05 Giga cells per liter (GI/L) | Standard Deviation 1.905 |
Primary
Change From Baseline in Albumin and Total Protein
Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including albumin and total protein. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline and up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Albumin; visit 1 (Screening); n= 83 | -1.6 Gram per liter (G/L) | Standard Deviation 2.72 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Albumin; visit 2 (Week 13); n= 87 | -0.9 Gram per liter (G/L) | Standard Deviation 2.7 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Albumin; visit 3 (Week 26); n= 75 | -0.8 Gram per liter (G/L) | Standard Deviation 2.83 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Albumin; visit 4 (Week 39); n= 70 | -0.7 Gram per liter (G/L) | Standard Deviation 3.09 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Albumin; visit 5 (Week 52); n= 65 | -1.5 Gram per liter (G/L) | Standard Deviation 3.25 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Albumin; visit 6 (Week 69); n= 62 | -1.1 Gram per liter (G/L) | Standard Deviation 3.11 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Albumin; visit 7 (Week 86); n= 54 | -1.0 Gram per liter (G/L) | Standard Deviation 2.7 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Albumin; visit 8 (Week 104); n= 42 | -1.6 Gram per liter (G/L) | Standard Deviation 3.05 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Albumin; visit 9 (Week 121); n= 39 | -2.1 Gram per liter (G/L) | Standard Deviation 2.88 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Albumin; visit 10 (Week 138); n= 36 | -2.2 Gram per liter (G/L) | Standard Deviation 3.16 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Albumin; visit 11 (Week 156); n= 30 | -3.0 Gram per liter (G/L) | Standard Deviation 3.62 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Albumin; visit 12 (Week 173); n= 23 | -1.7 Gram per liter (G/L) | Standard Deviation 2.82 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Albumin; visit 13 (Week 190); n= 19 | -2.9 Gram per liter (G/L) | Standard Deviation 3.62 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Albumin; visit14 (Week 208); n= 10 | -3.9 Gram per liter (G/L) | Standard Deviation 3.78 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Albumin; visit 15 (Week 225); n= 5 | -3.4 Gram per liter (G/L) | Standard Deviation 1.52 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Albumin; visit 16 (Week242); n= 4 | -4.3 Gram per liter (G/L) | Standard Deviation 1.26 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Albumin; visit 17 (Week 260); n= 4 | -4.0 Gram per liter (G/L) | Standard Deviation 1.15 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Albumin; visit 18 (Week 277); n= 2 | -4.5 Gram per liter (G/L) | Standard Deviation 0.71 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Albumin; withdrawal visit; n= 79 | -1.8 Gram per liter (G/L) | Standard Deviation 3.11 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Albumin; follow up visit; n= 60 | -2.3 Gram per liter (G/L) | Standard Deviation 3.42 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Total protein; visit 1 (Screening); n= 83 | -2.0 Gram per liter (G/L) | Standard Deviation 4.57 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Total protein; visit 2 (Week 13); n= 87 | -1.0 Gram per liter (G/L) | Standard Deviation 4.59 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Total protein; visit 3 (Week 26); n= 75 | -1.5 Gram per liter (G/L) | Standard Deviation 5.15 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Total protein; visit 4 (Week 39); n= 70 | -1.8 Gram per liter (G/L) | Standard Deviation 4.13 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Total protein; visit 5 (Week 52); n= 65 | -2.6 Gram per liter (G/L) | Standard Deviation 4.74 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Total protein; visit 6 (Week 69); n= 62 | -1.4 Gram per liter (G/L) | Standard Deviation 4.09 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Total protein; visit 7 (Week 86); n= 54 | -1.0 Gram per liter (G/L) | Standard Deviation 4.44 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Total protein; visit 8 (Week 104); n= 42 | -1.5 Gram per liter (G/L) | Standard Deviation 4.65 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Total protein; visit 9 (Week 121); n= 39 | -2.1 Gram per liter (G/L) | Standard Deviation 4.58 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Total protein; visit 10 (Week 138); n= 36 | -2.7 Gram per liter (G/L) | Standard Deviation 4.9 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Total protein; visit 11 (Week 156); n= 30 | -3.2 Gram per liter (G/L) | Standard Deviation 5.4 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Total protein; visit 12 (Week 173); n= 23 | -1.1 Gram per liter (G/L) | Standard Deviation 4.07 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Total protein; visit 13 (Week 190); n= 19 | -1.9 Gram per liter (G/L) | Standard Deviation 5.57 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Total protein; visit 14 (Week 208); n= 10 | -3.1 Gram per liter (G/L) | Standard Deviation 3.41 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Total protein; visit 15 (Week 225); n= 5 | -3.4 Gram per liter (G/L) | Standard Deviation 2.51 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Total protein; visit 16 (Week 242); n= 4 | -3.8 Gram per liter (G/L) | Standard Deviation 4.99 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Total protein; visit 17 (Week 260); n= 4 | -2.3 Gram per liter (G/L) | Standard Deviation 3.3 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Total protein; visit 18 (Week 277); n= 2 | -4.5 Gram per liter (G/L) | Standard Deviation 2.12 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Total protein; withdrawal visit; n= 79 | -2.5 Gram per liter (G/L) | Standard Deviation 5.27 |
| Retigabine IR | Change From Baseline in Albumin and Total Protein | Total protein; follow up visit; n= 60 | -2.1 Gram per liter (G/L) | Standard Deviation 6.12 |
Primary
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels
Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including alk. phosphatase, ALT, AST, creatine kinase and LD. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline and up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | ALT; visit 9 (Week 121); n= 39 | 0.4 International unit per liter (IU/L) | Standard Deviation 8.8 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | ALT; visit 10 (Week 138); n= 36 | 3.4 International unit per liter (IU/L) | Standard Deviation 21.74 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | ALT; visit 11 (Week 156); n= 29 | -1.1 International unit per liter (IU/L) | Standard Deviation 8.21 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | ALT; visit 12 (Week 173); n= 23 | -1.3 International unit per liter (IU/L) | Standard Deviation 7.97 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | ALT; visit 13 (Week 190); n= 19 | 0.0 International unit per liter (IU/L) | Standard Deviation 8.1 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | ALT; visit 14 (Week 208); n= 10 | 0.7 International unit per liter (IU/L) | Standard Deviation 7.32 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | ALT; visit 15 (Week 225); n= 5 | -2.0 International unit per liter (IU/L) | Standard Deviation 4.47 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | ALT; visit 16 (Week 242); n= 4 | -0.5 International unit per liter (IU/L) | Standard Deviation 8.54 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | ALT; visit 17 (Week 260); n= 4 | 0.0 International unit per liter (IU/L) | Standard Deviation 6.98 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | ALT; visit 18 (Week 277); n= 2 | 3.5 International unit per liter (IU/L) | Standard Deviation 3.54 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | ALT; withdrawal visit; n= 79 | 0.7 International unit per liter (IU/L) | Standard Deviation 10.17 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | ALT; follow up visit; n= 60 | 0.1 International unit per liter (IU/L) | Standard Deviation 8.43 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | AST; visit 1 (Screening); n= 82 | 1.7 International unit per liter (IU/L) | Standard Deviation 7.97 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | AST; visit 2 (Week 13); n= 86 | 5.1 International unit per liter (IU/L) | Standard Deviation 31.13 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | AST; visit 3 (Week 26); n= 75 | 2.9 International unit per liter (IU/L) | Standard Deviation 23.95 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | AST; visit 4 (Week 39); n= 70 | 1.3 International unit per liter (IU/L) | Standard Deviation 8.23 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | AST; visit 5 (Week 52); n= 65 | 2.5 International unit per liter (IU/L) | Standard Deviation 6.01 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | AST; visit 6 (Week 69); n= 62 | 1.5 International unit per liter (IU/L) | Standard Deviation 7.55 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | AST; visit 14 (Week 208); n= 10 | 3.5 International unit per liter (IU/L) | Standard Deviation 6.42 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | AST; visit 7 (Week 86); n= 54 | 1.7 International unit per liter (IU/L) | Standard Deviation 8.2 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | AST; visit 8 (Week 104); n= 42 | 1.5 International unit per liter (IU/L) | Standard Deviation 7.94 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | AST; visit 9 (Week 121); n= 39 | 2.6 International unit per liter (IU/L) | Standard Deviation 7.99 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | AST; visit 10 (Week 138); n= 36 | 6.4 International unit per liter (IU/L) | Standard Deviation 17.36 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | AST; visit 11 (Week 156); n= 30 | 1.4 International unit per liter (IU/L) | Standard Deviation 7.38 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | AST; visit 12 (Week 173); n= 23 | 2.7 International unit per liter (IU/L) | Standard Deviation 4.71 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | AST; visit 13 (Week 190); n= 19 | 3.3 International unit per liter (IU/L) | Standard Deviation 5.21 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | AST; visit 15 (Week 225); n= 5 | 4.2 International unit per liter (IU/L) | Standard Deviation 2.95 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | AST; visit 16 (Week 242); n= 4 | 4.3 International unit per liter (IU/L) | Standard Deviation 4.72 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | AST; visit 17 (Week 260); n= 4 | 5.5 International unit per liter (IU/L) | Standard Deviation 3.11 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | AST; visit 18 (Week 277); n= 2 | 10.0 International unit per liter (IU/L) | Standard Deviation 9.9 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | AST; withdrawal visit; n= 78 | 1.8 International unit per liter (IU/L) | Standard Deviation 7.87 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | AST; follow up visit; n= 60 | 1.2 International unit per liter (IU/L) | Standard Deviation 6.99 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Creatine kinase; Visit 1 (Screening); n= 82 | 16.4 International unit per liter (IU/L) | Standard Deviation 132.76 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Creatine kinase; Visit 2 (Week 13); n= 86 | 11.3 International unit per liter (IU/L) | Standard Deviation 78.18 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Creatine kinase; Visit 3 (Week 26); n= 74 | 11.7 International unit per liter (IU/L) | Standard Deviation 59.78 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Creatine kinase; Visit 4 (Week 39); n= 70 | 49.4 International unit per liter (IU/L) | Standard Deviation 397.67 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Creatine kinase; Visit 5 (Week 52); n= 65 | 31.3 International unit per liter (IU/L) | Standard Deviation 136.41 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Creatine kinase; Visit 6 (Week 69); n= 62 | 11.1 International unit per liter (IU/L) | Standard Deviation 55.13 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Creatine kinase; Visit 7 (Week 86); n= 54 | 23.6 International unit per liter (IU/L) | Standard Deviation 92.64 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Creatine kinase; Visit 8 (Week 104); n= 42 | 33.2 International unit per liter (IU/L) | Standard Deviation 110.99 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Creatine kinase; Visit 9 (Week 121); n= 39 | 22.5 International unit per liter (IU/L) | Standard Deviation 77.04 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Creatine kinase; Visit 10 (Week 138); n= 36 | 24.8 International unit per liter (IU/L) | Standard Deviation 83.8 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Creatine kinase; Visit 11 (Week 156); n= 30 | 31.9 International unit per liter (IU/L) | Standard Deviation 86.68 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Creatine kinase; Visit 12 (Week 173); n= 23 | 29.1 International unit per liter (IU/L) | Standard Deviation 97.1 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Creatine kinase; Visit 13 (Week 190); n= 19 | 50.2 International unit per liter (IU/L) | Standard Deviation 125.12 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Creatine kinase; Visit 14 (Week 208); n= 10 | -7.9 International unit per liter (IU/L) | Standard Deviation 101.39 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Creatine kinase; Visit 15 (Week 225); n= 5 | 42.6 International unit per liter (IU/L) | Standard Deviation 99.09 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Creatine kinase; Visit 16 (Week 242); n= 4 | 90.3 International unit per liter (IU/L) | Standard Deviation 127.49 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Creatine kinase; Visit 17 (Week 260); n= 4 | 78.8 International unit per liter (IU/L) | Standard Deviation 110.78 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Creatine kinase; Visit 18 (Week 277); n= 2 | -27.5 International unit per liter (IU/L) | Standard Deviation 102.53 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Creatine kinase; withdrawal visit; n= 78 | 28.7 International unit per liter (IU/L) | Standard Deviation 139.96 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Creatine kinase; follow up visit; n= 60 | 33.9 International unit per liter (IU/L) | Standard Deviation 128.19 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | LD; visit 1(Screening); n= 82 | 3.7 International unit per liter (IU/L) | Standard Deviation 23.16 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | LD; visit 2 (Week 13); n= 86 | 4.3 International unit per liter (IU/L) | Standard Deviation 32.66 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | LD; visit 3 (Week 26); n= 74 | 0.0 International unit per liter (IU/L) | Standard Deviation 27.88 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | LD; visit 4 (Week 39); n= 69 | 0.4 International unit per liter (IU/L) | Standard Deviation 28.51 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | LD; visit 5 (Week 52); n= 64 | 2.1 International unit per liter (IU/L) | Standard Deviation 28.01 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | LD; visit 6 (Week 69); n= 61 | -0.1 International unit per liter (IU/L) | Standard Deviation 25.98 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | LD; visit 7 (Week 86); n= 54 | 9.2 International unit per liter (IU/L) | Standard Deviation 30.42 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | LD; visit 8 (Week 104); n= 42 | 4.7 International unit per liter (IU/L) | Standard Deviation 29.37 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | LD; visit 9 (Week 121); n= 39 | 18.8 International unit per liter (IU/L) | Standard Deviation 53.56 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | LD; visit 10 (Week 138); n= 36 | 33.0 International unit per liter (IU/L) | Standard Deviation 131.87 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | LD; visit 11 (Week 156); n= 30 | 13.7 International unit per liter (IU/L) | Standard Deviation 33.18 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | LD; visit 12 (Week 173); n= 23 | 4.1 International unit per liter (IU/L) | Standard Deviation 31.91 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | LD; visit 13 (Week 190); n= 19 | 30.0 International unit per liter (IU/L) | Standard Deviation 58.17 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | LD; visit 14 (Week 208); n= 10 | 25.8 International unit per liter (IU/L) | Standard Deviation 42.76 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | LD; visit 15 (Week 225); n= 5 | 34.6 International unit per liter (IU/L) | Standard Deviation 25.93 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | LD; visit 16 (Week 242); n= 4 | 25.8 International unit per liter (IU/L) | Standard Deviation 15.97 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | LD; visit 17 (Week 260); n= 4 | 20.8 International unit per liter (IU/L) | Standard Deviation 25.86 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | LD; visit 18 (Week 277); n= 2 | 52.0 International unit per liter (IU/L) | Standard Deviation 60.81 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | LD; withdrawal visit; n= 78 | 7.8 International unit per liter (IU/L) | Standard Deviation 31.17 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | LD; follow up visit; n= 60 | 5.6 International unit per liter (IU/L) | Standard Deviation 36.94 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Alk. phosphatase; visit 1 (Screening); n= 82 | -2.7 International unit per liter (IU/L) | Standard Deviation 15.51 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Alk. phosphatase; visit 2 (Week 13); n= 86 | 1.1 International unit per liter (IU/L) | Standard Deviation 14.02 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Alk. phosphatase; visit 3 (Week 26); n= 75 | 3.5 International unit per liter (IU/L) | Standard Deviation 15.8 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Alk. phosphatase; visit 4 (week 39); n= 70 | 3.9 International unit per liter (IU/L) | Standard Deviation 15.46 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Alk. phosphatase; visit 5 (Week 52); n= 65 | 1.0 International unit per liter (IU/L) | Standard Deviation 15.36 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Alk. phosphatase; visit 6 (Week 69); n= 62 | 4.1 International unit per liter (IU/L) | Standard Deviation 14.22 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Alk. phosphatase; visit 7 (Week 86); n= 54 | 4.0 International unit per liter (IU/L) | Standard Deviation 16.01 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Alk. phosphatase; visit 8 (Week 104); n= 42 | -0.3 International unit per liter (IU/L) | Standard Deviation 18.27 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Alk. phosphatase; visit 9 (Week 121); n= 39 | 2.4 International unit per liter (IU/L) | Standard Deviation 16.33 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Alk. phosphatase; visit 10 (Week 138); n= 36 | 2.2 International unit per liter (IU/L) | Standard Deviation 21.08 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Alk. phosphatase; visit 11 (Week 156); n= 30 | -1.4 International unit per liter (IU/L) | Standard Deviation 18.49 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Alk. phosphatase; visit 12 (Week 173); n= 23 | 5.5 International unit per liter (IU/L) | Standard Deviation 20.76 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Alk. phosphatase; visit 13 (Week 190); n= 19 | 6.3 International unit per liter (IU/L) | Standard Deviation 23.61 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Alk. phosphatase; visit 14 (Week 208); n= 10 | 6.1 International unit per liter (IU/L) | Standard Deviation 19.84 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Alk. phosphatase; visit 15 (Week 225); n= 5 | 5.8 International unit per liter (IU/L) | Standard Deviation 16.95 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Alk. phosphatase; visit 16 (Week 242); n= 4 | 9.5 International unit per liter (IU/L) | Standard Deviation 15.55 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Alk. phosphatase; visit 17 (Week 260); n= 4 | 7.3 International unit per liter (IU/L) | Standard Deviation 7.14 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Alk. phosphatase; visit 18 (Week 277); n= 2 | -4.5 International unit per liter (IU/L) | Standard Deviation 10.61 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Alk. phosphatase; withdrawal visit; n= 78 | 2.5 International unit per liter (IU/L) | Standard Deviation 19.86 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | Alk. phosphatase; follow up visit; n= 60 | -0.3 International unit per liter (IU/L) | Standard Deviation 19.59 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | ALT; visit 1 (Screening); n= 83 | 1.3 International unit per liter (IU/L) | Standard Deviation 10.9 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | ALT; visit 2 (Week 13); n= 87 | 3.4 International unit per liter (IU/L) | Standard Deviation 23.41 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | ALT; visit 3 (Week 26); n= 76 | 1.0 International unit per liter (IU/L) | Standard Deviation 23.35 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | ALT; visit 4 (Week 39); n= 70 | -0.5 International unit per liter (IU/L) | Standard Deviation 10.22 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | ALT; visit 5 (Week 52); n= 65 | -0.4 International unit per liter (IU/L) | Standard Deviation 8.21 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | ALT; visit 6 (Week 69); n= 62 | -0.0 International unit per liter (IU/L) | Standard Deviation 11.51 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | ALT; visit 7 (Week 86); n= 54 | -1.9 International unit per liter (IU/L) | Standard Deviation 10.02 |
| Retigabine IR | Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels | ALT; visit 8 (Week 104); n= 42 | -1.5 International unit per liter (IU/L) | Standard Deviation 8.58 |
Primary
Change From Baseline in BUN/Creatinine Ratio
Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including BUN/creatinine ratio. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline and up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine IR | Change From Baseline in BUN/Creatinine Ratio | Visit 1 (Screening); n= 82 | 0.3 Ratio of BUN to creatinine | Standard Deviation 20.71 |
| Retigabine IR | Change From Baseline in BUN/Creatinine Ratio | Visit 2 (Week 13); n= 86 | 3.8 Ratio of BUN to creatinine | Standard Deviation 23.49 |
| Retigabine IR | Change From Baseline in BUN/Creatinine Ratio | Visit 3 (Week 26); n= 74 | 2.7 Ratio of BUN to creatinine | Standard Deviation 20.38 |
| Retigabine IR | Change From Baseline in BUN/Creatinine Ratio | Visit 4 (Week 39); n= 70 | 1.0 Ratio of BUN to creatinine | Standard Deviation 23.43 |
| Retigabine IR | Change From Baseline in BUN/Creatinine Ratio | Visit 5 (Week 52); n= 65 | 1.9 Ratio of BUN to creatinine | Standard Deviation 27.3 |
| Retigabine IR | Change From Baseline in BUN/Creatinine Ratio | Visit 6 (Week 69); n= 62 | -0.0 Ratio of BUN to creatinine | Standard Deviation 22.69 |
| Retigabine IR | Change From Baseline in BUN/Creatinine Ratio | Visit 7 (Week 86); n= 54 | 2.5 Ratio of BUN to creatinine | Standard Deviation 24.05 |
| Retigabine IR | Change From Baseline in BUN/Creatinine Ratio | Visit 8 (Week 104); n= 42 | -2.5 Ratio of BUN to creatinine | Standard Deviation 24.45 |
| Retigabine IR | Change From Baseline in BUN/Creatinine Ratio | Visit 9 (Week 121); n= 39 | 0.6 Ratio of BUN to creatinine | Standard Deviation 24.67 |
| Retigabine IR | Change From Baseline in BUN/Creatinine Ratio | Visit 10 (Week 138); n= 36 | 0.2 Ratio of BUN to creatinine | Standard Deviation 27.01 |
| Retigabine IR | Change From Baseline in BUN/Creatinine Ratio | Visit 11 (Week 156); n= 30 | -6.2 Ratio of BUN to creatinine | Standard Deviation 24.68 |
| Retigabine IR | Change From Baseline in BUN/Creatinine Ratio | Visit 12 (Week 173); n= 23 | -5.7 Ratio of BUN to creatinine | Standard Deviation 22.82 |
| Retigabine IR | Change From Baseline in BUN/Creatinine Ratio | Visit 13 (Week 190); n= 19 | 1.1 Ratio of BUN to creatinine | Standard Deviation 22.19 |
| Retigabine IR | Change From Baseline in BUN/Creatinine Ratio | Visit 14 (Week 208); n= 10 | -0.8 Ratio of BUN to creatinine | Standard Deviation 23.37 |
| Retigabine IR | Change From Baseline in BUN/Creatinine Ratio | Visit 15 (Week 225); n= 5 | -8.8 Ratio of BUN to creatinine | Standard Deviation 20.22 |
| Retigabine IR | Change From Baseline in BUN/Creatinine Ratio | Visit 16 (Week 242); n= 4 | 4.0 Ratio of BUN to creatinine | Standard Deviation 18.49 |
| Retigabine IR | Change From Baseline in BUN/Creatinine Ratio | Visit 17 (Week 260); n= 4 | 2.0 Ratio of BUN to creatinine | Standard Deviation 32.81 |
| Retigabine IR | Change From Baseline in BUN/Creatinine Ratio | Visit 18 (Week 277); n= 2 | 3.0 Ratio of BUN to creatinine | Standard Deviation 11.31 |
| Retigabine IR | Change From Baseline in BUN/Creatinine Ratio | Withdrawal visit; n= 78 | 4.2 Ratio of BUN to creatinine | Standard Deviation 23.96 |
| Retigabine IR | Change From Baseline in BUN/Creatinine Ratio | Follow up visit; n= 60 | 0.4 Ratio of BUN to creatinine | Standard Deviation 22.68 |
Primary
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN
Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including calcium, chloride, CO2, glucose, potassium, magnesium, sodium and BUN. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline and up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Calcium; visit 1 (Screening); n= 82 | -0.028 Millimoles per liter (mmol/L) | Standard Deviation 0.094 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Calcium; visit 2 (Week 13); n= 86 | -0.011 Millimoles per liter (mmol/L) | Standard Deviation 0.1067 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Calcium; visit 3 (Week 26); n= 74 | -0.026 Millimoles per liter (mmol/L) | Standard Deviation 0.1061 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Calcium; visit 4 (Week 39); n= 69 | -0.025 Millimoles per liter (mmol/L) | Standard Deviation 0.1024 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Calcium; visit 5 (Week 52); n= 64 | -0.026 Millimoles per liter (mmol/L) | Standard Deviation 0.11 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Calcium; visit 6 (Week 69); n= 61 | -0.019 Millimoles per liter (mmol/L) | Standard Deviation 0.0942 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Calcium; visit 7 (Week 86); n= 54 | -0.016 Millimoles per liter (mmol/L) | Standard Deviation 0.0911 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Calcium; visit 8 (Week 104); n= 42 | -0.008 Millimoles per liter (mmol/L) | Standard Deviation 0.0975 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Calcium; visit 9 (Week 121); n= 39 | -0.024 Millimoles per liter (mmol/L) | Standard Deviation 0.1096 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Calcium; visit 10 (Week 138); n= 36 | -0.038 Millimoles per liter (mmol/L) | Standard Deviation 0.1335 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Calcium; visit 11 (Week 156); n= 30 | -0.053 Millimoles per liter (mmol/L) | Standard Deviation 0.1181 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Calcium; visit 12 (Week 173); n= 23 | -0.059 Millimoles per liter (mmol/L) | Standard Deviation 0.1031 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Calcium; visit 13 (Week 190); n= 19 | -0.074 Millimoles per liter (mmol/L) | Standard Deviation 0.1 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Calcium; visit 14 (Week 208); n= 10 | -0.094 Millimoles per liter (mmol/L) | Standard Deviation 0.095 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Calcium; visit 15 (Week 225); n= 5 | -0.108 Millimoles per liter (mmol/L) | Standard Deviation 0.0858 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Calcium; visit 16 (Week 242); n= 4 | -0.093 Millimoles per liter (mmol/L) | Standard Deviation 0.0877 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Calcium; visit 17 (Week 260); n= 4 | -0.073 Millimoles per liter (mmol/L) | Standard Deviation 0.067 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Calcium; visit 18 (Week 277); n= 2 | -0.125 Millimoles per liter (mmol/L) | Standard Deviation 0.02122 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Calcium; withdrawal visit; n= 78 | -0.033 Millimoles per liter (mmol/L) | Standard Deviation 0.1148 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Calcium; follow up visit; n= 60 | -0.050 Millimoles per liter (mmol/L) | Standard Deviation 0.1059 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Chloride; visit 1 (Screening); n= 83 | 0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.88 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Chloride; visit 2 (Week 13); n= 87 | 0.4 Millimoles per liter (mmol/L) | Standard Deviation 2.73 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Chloride; visit 3 (Week 26); n=75 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.79 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Chloride; visit 4 (Week 39); n= 70 | 1.5 Millimoles per liter (mmol/L) | Standard Deviation 2.8 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Chloride; visit 5 (Week 52); n= 65 | 1.2 Millimoles per liter (mmol/L) | Standard Deviation 3.58 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Chloride; visit 6 (Week 69); n= 62 | 0.4 Millimoles per liter (mmol/L) | Standard Deviation 2.68 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Chloride; visit 7 (Week 86); n= 54 | 1.5 Millimoles per liter (mmol/L) | Standard Deviation 3.34 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Chloride; visit 8 (Week 104); n= 42 | 1.3 Millimoles per liter (mmol/L) | Standard Deviation 2.83 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Chloride; visit 9 (Week 121); n= 39 | 1.4 Millimoles per liter (mmol/L) | Standard Deviation 3.28 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Chloride; visit 10 (Week 138); n= 36 | 1.2 Millimoles per liter (mmol/L) | Standard Deviation 3.35 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Chloride; visit 11 (Week 156); n= 30 | 2.0 Millimoles per liter (mmol/L) | Standard Deviation 2.99 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Chloride; visit 12 (Week 173); n= 23 | 1.6 Millimoles per liter (mmol/L) | Standard Deviation 2.74 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Chloride; visit 13 (Week 190); n= 19 | 2.4 Millimoles per liter (mmol/L) | Standard Deviation 2.09 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Chloride; visit 14 (Week 208); n= 10 | 1.2 Millimoles per liter (mmol/L) | Standard Deviation 2.49 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Chloride; visit 15 (Week 225); n= 5 | 1.2 Millimoles per liter (mmol/L) | Standard Deviation 3.11 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Chloride; visit 16 (Week 242); n= 4 | 2.0 Millimoles per liter (mmol/L) | Standard Deviation 2 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Chloride; visit 17 (Week 260); n= 4 | 3.5 Millimoles per liter (mmol/L) | Standard Deviation 3.11 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Chloride; visit 18 (Week 277); n= 2 | -0.5 Millimoles per liter (mmol/L) | Standard Deviation 0.71 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Chloride; withdrawal visit; n= 79 | 0.6 Millimoles per liter (mmol/L) | Standard Deviation 2.89 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Chloride; follow up visit; n= 60 | -0.0 Millimoles per liter (mmol/L) | Standard Deviation 2.79 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | CO2; visit 1 (Screening); n= 82 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 3.07 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | CO2; visit 2 (Week 13); n= 86 | 0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.42 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | CO2; visit 3 (Week 26); n= 74 | 0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.82 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | CO2; visit 4 (Week 39); n= 69 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 3.03 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | CO2; visit 5 (Week 52); n= 64 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.88 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | CO2; visit 6 (Week 69); n= 61 | -0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.99 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | CO2; visit 7 (Week 86); n= 54 | -0.6 Millimoles per liter (mmol/L) | Standard Deviation 2.71 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | CO2; visit 8 (Week 104); n= 42 | -0.6 Millimoles per liter (mmol/L) | Standard Deviation 2.64 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | CO2; visit 9 (Week 121); n= 39 | -1.0 Millimoles per liter (mmol/L) | Standard Deviation 3.02 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | CO2; visit 10 (Week 138); n= 36 | -0.9 Millimoles per liter (mmol/L) | Standard Deviation 3.42 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | CO2; visit 11 (Week 156); n= 30 | -1.0 Millimoles per liter (mmol/L) | Standard Deviation 2.48 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | CO2; visit 12 (Week 173); n= 23 | -0.9 Millimoles per liter (mmol/L) | Standard Deviation 2.8 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | CO2; visit 13 (Week 190); n= 19 | -1.5 Millimoles per liter (mmol/L) | Standard Deviation 3.39 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | CO2; visit 14 (Week 208); n= 10 | -3.6 Millimoles per liter (mmol/L) | Standard Deviation 4.53 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | CO2; visit 15 (Week 225); n= 5 | -2.4 Millimoles per liter (mmol/L) | Standard Deviation 1.82 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | CO2; visit 16 (Week 242); n= 4 | -1.0 Millimoles per liter (mmol/L) | Standard Deviation 1.41 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | CO2; visit 17 (Week 260); n= 4 | -0.5 Millimoles per liter (mmol/L) | Standard Deviation 0.58 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | CO2; visit 18 (Week 277); n= 2 | -0.5 Millimoles per liter (mmol/L) | Standard Deviation 0.71 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | CO2; withdrawal visit; n= 78 | -0.0 Millimoles per liter (mmol/L) | Standard Deviation 2.33 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | CO2; follow up visit; n= 60 | -0.8 Millimoles per liter (mmol/L) | Standard Deviation 2.92 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Glucose; visit 1 (Screening); n= 83 | 0.20 Millimoles per liter (mmol/L) | Standard Deviation 1.303 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Glucose; visit 2 (Week 13); n= 87 | 0.16 Millimoles per liter (mmol/L) | Standard Deviation 0.933 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Glucose; visit 3 (Week 26); n= 75 | 0.17 Millimoles per liter (mmol/L) | Standard Deviation 0.765 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Glucose; visit 4 (Week 39); n= 70 | 0.40 Millimoles per liter (mmol/L) | Standard Deviation 1.259 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Glucose; visit 5 (Week 52); n= 65 | 0.23 Millimoles per liter (mmol/L) | Standard Deviation 0.814 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Glucose; visit 6 (Week 69); n= 62 | 0.25 Millimoles per liter (mmol/L) | Standard Deviation 1.103 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Glucose; visit 7 (Week 86); n= 54 | 0.21 Millimoles per liter (mmol/L) | Standard Deviation 0.985 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Glucose; visit 8 (Week 104); n= 42 | 0.21 Millimoles per liter (mmol/L) | Standard Deviation 0.679 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Glucose; visit 9 (Week 121); n= 39 | 0.31 Millimoles per liter (mmol/L) | Standard Deviation 1.073 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Glucose; visit 10 (Week 138); n= 36 | 0.30 Millimoles per liter (mmol/L) | Standard Deviation 1.007 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Glucose; visit 11 (Week 156); n= 30 | 0.10 Millimoles per liter (mmol/L) | Standard Deviation 0.511 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Glucose; visit 12 (Week 173); n= 23 | -0.03 Millimoles per liter (mmol/L) | Standard Deviation 0.82 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Glucose; visit 13 (Week 190); n= 19 | 0.21 Millimoles per liter (mmol/L) | Standard Deviation 1.446 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Glucose; visit 14 (Week 208); n= 10 | 0.15 Millimoles per liter (mmol/L) | Standard Deviation 0.412 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Glucose; visit 15 (Week 225); n= 5 | 0.38 Millimoles per liter (mmol/L) | Standard Deviation 0.981 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Glucose; visit 16 (Week 242); n= 4 | 1.95 Millimoles per liter (mmol/L) | Standard Deviation 3.313 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Glucose; visit 17 (Week 260); n= 4 | -0.10 Millimoles per liter (mmol/L) | Standard Deviation 0.648 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Glucose; visit 18 (Week 277); n= 2 | -0.30 Millimoles per liter (mmol/L) | Standard Deviation 0.141 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Glucose; withdrawal visit; n= 79 | 0.14 Millimoles per liter (mmol/L) | Standard Deviation 1.035 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Glucose; follow up visit; n= 60 | 0.39 Millimoles per liter (mmol/L) | Standard Deviation 1.162 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Potassium; visit 1 (Screening); n= 82 | -0.04 Millimoles per liter (mmol/L) | Standard Deviation 0.467 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Potassium; visit 2 (Week 13); n= 86 | -0.07 Millimoles per liter (mmol/L) | Standard Deviation 0.403 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Potassium; visit 3 (Week 26); n= 74 | -0.09 Millimoles per liter (mmol/L) | Standard Deviation 0.453 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Potassium; visit 4 (Week 39); n= 69 | -0.11 Millimoles per liter (mmol/L) | Standard Deviation 0.432 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Potassium; visit 5 (Week 52); n= 64 | -0.13 Millimoles per liter (mmol/L) | Standard Deviation 0.43 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Potassium; visit 6 (Week 69); n= 61 | -0.21 Millimoles per liter (mmol/L) | Standard Deviation 0.42 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Potassium; visit 7 (Week 86); n= 54 | -0.13 Millimoles per liter (mmol/L) | Standard Deviation 0.411 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Potassium; visit 8 (Week 104); n= 42 | -0.05 Millimoles per liter (mmol/L) | Standard Deviation 0.433 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Potassium; visit 9 (Week 121); n= 39 | -0.09 Millimoles per liter (mmol/L) | Standard Deviation 0.376 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Potassium; visit 10 (Week 138); n= 36 | -0.07 Millimoles per liter (mmol/L) | Standard Deviation 0.388 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Potassium; visit 11 (Week 156); n= 30 | -0.16 Millimoles per liter (mmol/L) | Standard Deviation 0.39 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Potassium; visit 12 (Week 173); n= 23 | -0.13 Millimoles per liter (mmol/L) | Standard Deviation 0.411 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Potassium; visit 13 (Week 190); n= 19 | -0.02 Millimoles per liter (mmol/L) | Standard Deviation 0.351 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Potassium; visit 14 (Week 208); n= 10 | -0.16 Millimoles per liter (mmol/L) | Standard Deviation 0.43 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Potassium; visit 15 (Week 225); n= 5 | 0.14 Millimoles per liter (mmol/L) | Standard Deviation 0.321 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Potassium; visit 16 (Week 242); n= 4 | 0.30 Millimoles per liter (mmol/L) | Standard Deviation 0.294 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Potassium; visit 17 (Week 260); n= 4 | 0.25 Millimoles per liter (mmol/L) | Standard Deviation 0.351 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Potassium; visit 18 (Week 277); n= 2 | 0.10 Millimoles per liter (mmol/L) | Standard Deviation 0.424 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Potassium; withdrawal visit; n= 78 | -0.04 Millimoles per liter (mmol/L) | Standard Deviation 0.367 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Potassium; follow up visit; n= 60 | -0.20 Millimoles per liter (mmol/L) | Standard Deviation 0.478 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Magnesium; visit 1 (Screening); n= 83 | -0.017 Millimoles per liter (mmol/L) | Standard Deviation 0.0576 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Magnesium; visit 2 (Week 13); n= 87 | -0.012 Millimoles per liter (mmol/L) | Standard Deviation 0.0558 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Magnesium; visit 3 (Week 26); n= 75 | -0.007 Millimoles per liter (mmol/L) | Standard Deviation 0.0619 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Magnesium; visit 4 (Week 39); n= 70 | -0.004 Millimoles per liter (mmol/L) | Standard Deviation 0.058 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Magnesium; visit 5 (Week 52); n= 65 | -0.008 Millimoles per liter (mmol/L) | Standard Deviation 0.0625 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Magnesium; visit 6 (Week 69); n= 62 | -0.012 Millimoles per liter (mmol/L) | Standard Deviation 0.0599 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Magnesium; visit 7 (Week 86); n= 54 | -0.018 Millimoles per liter (mmol/L) | Standard Deviation 0.0627 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Magnesium; visit 8 (Week 104); n= 42 | 0.007 Millimoles per liter (mmol/L) | Standard Deviation 0.0632 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Magnesium; visit 9 (Week 121); n= 39 | -0.011 Millimoles per liter (mmol/L) | Standard Deviation 0.0763 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Magnesium; visit 10 (Week 138); n= 36 | -0.007 Millimoles per liter (mmol/L) | Standard Deviation 0.0543 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Magnesium; visit 11 (Week 156); n= 30 | 0.005 Millimoles per liter (mmol/L) | Standard Deviation 0.0651 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Magnesium; visit 12 (Week 173); n= 23 | -0.003 Millimoles per liter (mmol/L) | Standard Deviation 0.0688 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Magnesium; visit 13 (Week 190); n= 19 | -0.000 Millimoles per liter (mmol/L) | Standard Deviation 0.0627 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Magnesium; visit 14 (Week 208); n= 10 | -0.013 Millimoles per liter (mmol/L) | Standard Deviation 0.0579 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Magnesium; visit 15 (Week 225); n= 5 | 0.000 Millimoles per liter (mmol/L) | Standard Deviation 0.0474 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Magnesium; visit 16 (Week 242); n= 4 | -0.008 Millimoles per liter (mmol/L) | Standard Deviation 0.1075 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Magnesium; visit 17 (Week 260); n= 4 | 0.053 Millimoles per liter (mmol/L) | Standard Deviation 0.1258 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Magnesium; visit 18 (Week 277); n= 2 | 0.070 Millimoles per liter (mmol/L) | Standard Deviation 0.0424 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Magnesium; withdrawal visit; n= 79 | -0.003 Millimoles per liter (mmol/L) | Standard Deviation 0.0763 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Magnesium; follow up visit; n= 60 | -0.007 Millimoles per liter (mmol/L) | Standard Deviation 0.0727 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Sodium; visit 1 (Screening); n= 83 | 0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.88 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Sodium; visit 2 (Week 13); n= 80 | 0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.83 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Sodium; visit 3 (Week 26); n= 69 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.79 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Sodium; visit 4 (Week 39); n= 64 | 0.7 Millimoles per liter (mmol/L) | Standard Deviation 2.37 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Sodium; visit 5 (Week 52); n= 59 | 0.5 Millimoles per liter (mmol/L) | Standard Deviation 3.35 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Sodium; visit 6 (Week 69); n= 58 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.34 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Sodium; visit 7 (Week 86); n= 51 | 0.6 Millimoles per liter (mmol/L) | Standard Deviation 3.03 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Sodium; visit 8 (Week 104); n= 39 | 0.9 Millimoles per liter (mmol/L) | Standard Deviation 2.28 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Sodium; visit 9 (Week 121); n= 36 | 0.7 Millimoles per liter (mmol/L) | Standard Deviation 2.78 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Sodium; visit 10 (Week 138); n= 35 | 0.3 Millimoles per liter (mmol/L) | Standard Deviation 3.06 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Sodium; visit 11 (Week 156); n= 28 | 0.9 Millimoles per liter (mmol/L) | Standard Deviation 3.47 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Sodium; visit 12 (Week 173); n= 21 | 0.7 Millimoles per liter (mmol/L) | Standard Deviation 3.38 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Sodium; visit 13 (Week 190); n= 17 | 0.6 Millimoles per liter (mmol/L) | Standard Deviation 1.73 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Sodium; visit 14 (Week 208); n= 10 | -1.2 Millimoles per liter (mmol/L) | Standard Deviation 1.03 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Sodium; visit 15 (Week 225); n= 5 | -0.4 Millimoles per liter (mmol/L) | Standard Deviation 1.52 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Sodium; visit 16 (Week 242); n= 4 | -0.8 Millimoles per liter (mmol/L) | Standard Deviation 1.89 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Sodium; visit 17 (Week 260); n= 4 | 0.8 Millimoles per liter (mmol/L) | Standard Deviation 2.63 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Sodium; visit 18 (Week 277); n= 2 | -1.0 Millimoles per liter (mmol/L) | Standard Deviation 0 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Sodium; withdrawal visit; n= 71 | 0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.85 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | Sodium; follow up visit; n= 53 | -0.7 Millimoles per liter (mmol/L) | Standard Deviation 2.45 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | BUN; visit 1 (Screening); n= 83 | 0.32 Millimoles per liter (mmol/L) | Standard Deviation 1.317 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | BUN; visit 2 (Week 13); n= 80 | 0.44 Millimoles per liter (mmol/L) | Standard Deviation 1.483 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | BUN; visit 3 (Week 26); n= 69 | 0.31 Millimoles per liter (mmol/L) | Standard Deviation 1.287 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | BUN; visit 4 (Week 39); n= 64 | 0.22 Millimoles per liter (mmol/L) | Standard Deviation 1.322 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | BUN; visit 5 (Week 52); n= 59 | 0.37 Millimoles per liter (mmol/L) | Standard Deviation 1.643 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | BUN; visit 6 (Week 69); n= 58 | 0.13 Millimoles per liter (mmol/L) | Standard Deviation 1.329 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | BUN; visit 7 (Week 86); n= 51 | 0.22 Millimoles per liter (mmol/L) | Standard Deviation 1.467 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | BUN; visit 8 (Week 104); n= 39 | 0.22 Millimoles per liter (mmol/L) | Standard Deviation 1.477 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | BUN; visit 9 (Week 121); n= 36 | 0.35 Millimoles per liter (mmol/L) | Standard Deviation 1.444 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | BUN; visit 10 (Week 138); n= 35 | 0.18 Millimoles per liter (mmol/L) | Standard Deviation 1.578 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | BUN; visit 11 (Week 156); n= 28 | -0.06 Millimoles per liter (mmol/L) | Standard Deviation 1.515 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | BUN; visit 12 (Week 173); n= 21 | -0.40 Millimoles per liter (mmol/L) | Standard Deviation 1.362 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | BUN; visit 13 (Week 190); n= 17 | 0.23 Millimoles per liter (mmol/L) | Standard Deviation 1.088 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | BUN; visit 14 (Week 208); n= 10 | -0.11 Millimoles per liter (mmol/L) | Standard Deviation 1.604 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | BUN; visit 15 (Week 225); n= 5 | -0.40 Millimoles per liter (mmol/L) | Standard Deviation 1.416 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | BUN; visit 16 (Week 242); n= 4 | 0.80 Millimoles per liter (mmol/L) | Standard Deviation 0.707 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | BUN; visit 17 (Week 260); n= 4 | 1.10 Millimoles per liter (mmol/L) | Standard Deviation 2.889 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | BUN; visit 18 (Week 277); n= 2 | 0.50 Millimoles per liter (mmol/L) | Standard Deviation 0.141 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | BUN; withdrawal visit; n= 71 | 0.49 Millimoles per liter (mmol/L) | Standard Deviation 1.45 |
| Retigabine IR | Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN | BUN; follow up visit; n= 53 | 0.14 Millimoles per liter (mmol/L) | Standard Deviation 1.468 |
Primary
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine
Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including direct bilirubin, total bilirubin and creatinine. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline and up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Direct bilirubin; visit 1 (Screening); n= 83 | 0.1 Micromole per liter (µmol/L) | Standard Deviation 0.95 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Direct bilirubin; visit 2 (Week 13); n= 87 | -0.1 Micromole per liter (µmol/L) | Standard Deviation 0.96 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Direct bilirubin; visit 3 (Week 26); n= 75 | -0.2 Micromole per liter (µmol/L) | Standard Deviation 0.94 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Direct bilirubin; visit 4 (Week 39); n= 69 | -0.1 Micromole per liter (µmol/L) | Standard Deviation 0.91 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Direct bilirubin; visit 5 (Week 52); n= 65 | 0.0 Micromole per liter (µmol/L) | Standard Deviation 0.95 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Direct bilirubin; visit 6 (Week 69); n= 62 | -0.0 Micromole per liter (µmol/L) | Standard Deviation 0.97 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Direct bilirubin; visit 7 (Week 86); n= 54 | -0.2 Micromole per liter (µmol/L) | Standard Deviation 1.17 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Direct bilirubin; visit 8 (Week 104); n= 42 | -0.0 Micromole per liter (µmol/L) | Standard Deviation 0.91 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Direct bilirubin; visit 9 (Week 121); n= 39 | -0.2 Micromole per liter (µmol/L) | Standard Deviation 0.87 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Direct bilirubin; visit 10 (Week 138); n= 36 | -0.1 Micromole per liter (µmol/L) | Standard Deviation 1.27 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Direct bilirubin; visit 11 (Week 156); n= 30 | 0.0 Micromole per liter (µmol/L) | Standard Deviation 0.72 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Direct bilirubin; visit 12 (Week 173); n= 23 | -0.1 Micromole per liter (µmol/L) | Standard Deviation 0.73 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Direct bilirubin; visit 13 (Week 190); n= 19 | 0.1 Micromole per liter (µmol/L) | Standard Deviation 0.91 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Direct bilirubin; visit 14 (Week 208); n= 10 | 0.0 Micromole per liter (µmol/L) | Standard Deviation 0.67 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Direct bilirubin; visit 15 (Week 225); n= 5 | -0.2 Micromole per liter (µmol/L) | Standard Deviation 0.84 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Direct bilirubin; visit 16 (Week 242); n= 4 | -0.5 Micromole per liter (µmol/L) | Standard Deviation 1 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Direct bilirubin; visit 17 (Week 260); n= 4 | -0.5 Micromole per liter (µmol/L) | Standard Deviation 1.29 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Direct bilirubin; visit 18 (Week 277); n= 2 | 0.5 Micromole per liter (µmol/L) | Standard Deviation 2.12 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Direct bilirubin; withdrawal visit; n= 79 | 0.0 Micromole per liter (µmol/L) | Standard Deviation 1.15 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Direct bilirubin; follow up visit; n= 60 | -0.2 Micromole per liter (µmol/L) | Standard Deviation 0.98 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Total bilirubin; visit 1 (Screening); n= 83 | 2.5 Micromole per liter (µmol/L) | Standard Deviation 3.78 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Total bilirubin; visit 2 (Week 13); n= 87 | 1.8 Micromole per liter (µmol/L) | Standard Deviation 4.28 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Total bilirubin; visit 3 (Week 26); n= 76 | 1.8 Micromole per liter (µmol/L) | Standard Deviation 3.78 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Total bilirubin; visit 4 (Week 39); n= 70 | 2.1 Micromole per liter (µmol/L) | Standard Deviation 4.46 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Total bilirubin; visit 5 (Week 52); n= 65 | 2.6 Micromole per liter (µmol/L) | Standard Deviation 4.26 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Total bilirubin; visit 6 (Week 69); n= 62 | 1.8 Micromole per liter (µmol/L) | Standard Deviation 4.21 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Total bilirubin; visit 7 (Week 86); n= 54 | 1.4 Micromole per liter (µmol/L) | Standard Deviation 4.41 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Total bilirubin; visit 8 (Week 104); n= 42 | 1.8 Micromole per liter (µmol/L) | Standard Deviation 3.28 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Total bilirubin; visit 9 (Week 121); n= 39 | 1.1 Micromole per liter (µmol/L) | Standard Deviation 3.59 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Total bilirubin; visit 10 (Week 138); n= 36 | 1.6 Micromole per liter (µmol/L) | Standard Deviation 6.5 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Total bilirubin; visit 11 (Week 156); n= 30 | 0.5 Micromole per liter (µmol/L) | Standard Deviation 2.99 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Total bilirubin; visit 12 (Week 173); n= 23 | 0.6 Micromole per liter (µmol/L) | Standard Deviation 2.81 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Total bilirubin; visit 13 (Week 190); n= 19 | 0.2 Micromole per liter (µmol/L) | Standard Deviation 4.26 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Total bilirubin; visit 14 (Week 208); n= 10 | 0.3 Micromole per liter (µmol/L) | Standard Deviation 3.27 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Total bilirubin; visit 15 (Week 225); n= 5 | 0.8 Micromole per liter (µmol/L) | Standard Deviation 2.17 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Total bilirubin; visit 16 (Week 242); n= 4 | 1.3 Micromole per liter (µmol/L) | Standard Deviation 1.89 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Total bilirubin; visit 17 (Week 260); n= 4 | -0.3 Micromole per liter (µmol/L) | Standard Deviation 2.63 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Total bilirubin; visit 18 (Week 277); n= 2 | 1.5 Micromole per liter (µmol/L) | Standard Deviation 0.71 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Total bilirubin; withdrawal visit; n= 79 | 1.2 Micromole per liter (µmol/L) | Standard Deviation 3.75 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Total bilirubin; follow up visit; n= 60 | -0.8 Micromole per liter (µmol/L) | Standard Deviation 3.97 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Creatinine; visit 1 (Screening); n= 82 | 3.68 Micromole per liter (µmol/L) | Standard Deviation 9.813 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Creatinine; visit 2 (Week 13); n= 86 | 0.42 Micromole per liter (µmol/L) | Standard Deviation 8.033 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Creatinine; visit 3 (Week 26); n= 74 | 0.65 Micromole per liter (µmol/L) | Standard Deviation 8.879 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Creatinine; visit 4 (Week 39); n= 70 | 1.82 Micromole per liter (µmol/L) | Standard Deviation 9.716 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Creatinine; visit 5 (Week 52); n= 65 | 1.40 Micromole per liter (µmol/L) | Standard Deviation 9.394 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Creatinine; visit 6 (Week 69); n= 62 | 1.25 Micromole per liter (µmol/L) | Standard Deviation 8.98 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Creatinine; visit 7 (Week 86); n= 54 | 0.55 Micromole per liter (µmol/L) | Standard Deviation 9.053 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Creatinine; visit 8 (Week 104); n= 42 | 4.78 Micromole per liter (µmol/L) | Standard Deviation 8.921 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Creatinine; visit 9 (Week 121); n= 39 | 3.67 Micromole per liter (µmol/L) | Standard Deviation 9.581 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Creatinine; visit 10 (Week 138); n= 36 | 2.10 Micromole per liter (µmol/L) | Standard Deviation 11.317 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Creatinine; visit 11 (Week 156); n= 30 | 5.33 Micromole per liter (µmol/L) | Standard Deviation 11.211 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Creatinine; visit 12 (Week 173); n= 23 | -0.93 Micromole per liter (µmol/L) | Standard Deviation 10.097 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Creatinine; visit 13 (Week 190); n= 19 | 1.67 Micromole per liter (µmol/L) | Standard Deviation 11.314 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Creatinine; visit 14 (Week 208); n= 10 | -1.74 Micromole per liter (µmol/L) | Standard Deviation 13.636 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Creatinine; visit 15 (Week 225); n= 5 | 2.08 Micromole per liter (µmol/L) | Standard Deviation 6.68 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Creatinine; visit 16 (Week 242); n= 4 | 5.80 Micromole per liter (µmol/L) | Standard Deviation 8.844 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Creatinine; visit 17 (Week 260); n= 4 | 9.23 Micromole per liter (µmol/L) | Standard Deviation 14.076 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Creatinine; visit 18 (Week 277); n= 2 | 3.45 Micromole per liter (µmol/L) | Standard Deviation 8.697 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Creatinine; withdrawal visit; n= 78 | 0.88 Micromole per liter (µmol/L) | Standard Deviation 8.92 |
| Retigabine IR | Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine | Creatinine; follow up visit; n= 60 | 0.16 Micromole per liter (µmol/L) | Standard Deviation 9.873 |
Primary
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval
Single measurements of 12-lead ECG were obtained in supine position after at least 10 minutes of rest using an ECG machine to measure parameters including PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF and RR interval. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline and up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | PR interval; Visit 2 (Week 13); n= 88 | 1.3 Milliseconds (msec) | Standard Deviation 15.42 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | PR interval; Visit 3 (Week 26); n= 78 | 3.2 Milliseconds (msec) | Standard Deviation 12.99 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | PR interval; Visit 6 (Week 69); n= 62 | 1.3 Milliseconds (msec) | Standard Deviation 13.93 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | PR interval; Visit 8 (Week 104); n= 42 | 3.1 Milliseconds (msec) | Standard Deviation 10.85 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | PR interval; Visit 9 (Week 121); n= 38 | -1.1 Milliseconds (msec) | Standard Deviation 12.79 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | PR interval; Withdrawal visit; n= 81 | 3.6 Milliseconds (msec) | Standard Deviation 13.86 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QRS duration; Visit 13 (Week 190); n= 19 | -4.9 Milliseconds (msec) | Standard Deviation 8.8 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QRS duration; Visit 14 (Week 208); n= 10 | -6.1 Milliseconds (msec) | Standard Deviation 6.34 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QRS duration; Visit 16 (Week 242); n= 4 | -5.9 Milliseconds (msec) | Standard Deviation 9.58 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | Uncorrected QT interval; Visit 4 (Week 39); n= 69 | 9.3 Milliseconds (msec) | Standard Deviation 23.77 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | Uncorrected QT interval; Visit 5 (Week 52); n= 65 | 6.6 Milliseconds (msec) | Standard Deviation 25.18 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | Uncorrected QT interval; Visit 6 (Week 69); n= 61 | 7.4 Milliseconds (msec) | Standard Deviation 26.39 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | Uncorrected QT interval; Visit 7 (Week 86); n= 53 | -1.6 Milliseconds (msec) | Standard Deviation 23.81 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | Uncorrected QT interval; Visit 10 (Week 138);n= 36 | -8.7 Milliseconds (msec) | Standard Deviation 33.6 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | Uncorrected QT interval; Visit 11 (Week 156);n= 29 | -4.9 Milliseconds (msec) | Standard Deviation 33.01 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | Uncorrected QT interval; Visit 12 (Week 173);n= 23 | 4.7 Milliseconds (msec) | Standard Deviation 25.06 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | Uncorrected QT interval; Visit 13 (Week 190);n= 19 | -1.9 Milliseconds (msec) | Standard Deviation 26.01 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | Uncorrected QT interval; Visit 14 (Week 208);n= 10 | -17.0 Milliseconds (msec) | Standard Deviation 27.93 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | Uncorrected QT interval; Visit 15 (Week 225);n= 5 | -1.5 Milliseconds (msec) | Standard Deviation 5.68 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | Uncorrected QT interval; Visit 16 (Week 242);n= 4 | 3.1 Milliseconds (msec) | Standard Deviation 26.9 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | Uncorrected QT interval; Visit 17 (Week 260);n= 4 | 17.5 Milliseconds (msec) | Standard Deviation 36.08 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | Uncorrected QT interval; Visit 18 (Week 277);n= 2 | -3.5 Milliseconds (msec) | Standard Deviation 36.06 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcF; Visit 16 (Week 242); n= 4 | -5.4 Milliseconds (msec) | Standard Deviation 8.96 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | RR interval; visit 2 (Week 13); n= 90 | 12.2 Milliseconds (msec) | Standard Deviation 115.82 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | RR interval; visit 5 (Week 52); n= 67 | 10.3 Milliseconds (msec) | Standard Deviation 128.05 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | RR interval; follow up visit; n= 59 | 15.9 Milliseconds (msec) | Standard Deviation 150.13 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | PR interval; Visit 1 (Screening); n= 86 | 2.4 Milliseconds (msec) | Standard Deviation 13.11 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | PR interval; Visit 4 (Week 39); n= 70 | 1.2 Milliseconds (msec) | Standard Deviation 13.25 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | PR interval; visit 5 (Week 52); n= 66 | -0.2 Milliseconds (msec) | Standard Deviation 13.17 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | PR interval; Visit 7 (Week 86); n= 54 | -0.7 Milliseconds (msec) | Standard Deviation 12.58 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | PR interval; Visit 10 (Week 138); n= 37 | 1.2 Milliseconds (msec) | Standard Deviation 15.13 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | PR interval; Visit 11 (Week 156); n= 30 | -0.5 Milliseconds (msec) | Standard Deviation 13.5 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | PR interval; Visit 12 (Week 173); n= 24 | 4.8 Milliseconds (msec) | Standard Deviation 11.89 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | PR interval; Visit 13 (week 190); n= 19 | -2.1 Milliseconds (msec) | Standard Deviation 10.19 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | PR interval; Visit 14 (Week 208); n= 10 | 7.8 Milliseconds (msec) | Standard Deviation 15.03 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | PR interval; Visit 15 (Week 225); n= 5 | 8.4 Milliseconds (msec) | Standard Deviation 7.23 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | PR interval; Visit 16 (Week 242); n= 4 | -3.0 Milliseconds (msec) | Standard Deviation 8.04 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | PR interval; Visit 17 (Week 260); n= 4 | 9.3 Milliseconds (msec) | Standard Deviation 11.09 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | PR interval; Visit 18 (Week 277); n= 2 | -5.5 Milliseconds (msec) | Standard Deviation 7.78 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | PR interval; follow up visit; n= 57 | 3.7 Milliseconds (msec) | Standard Deviation 12.43 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QRS duration; Visit 1 (Screening); n= 88 | -0.1 Milliseconds (msec) | Standard Deviation 6.37 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QRS duration; Visit 2 (Week 13); n= 89 | 0.2 Milliseconds (msec) | Standard Deviation 6.99 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QRS duration; Visit 3 (Week 26); n= 80 | 1.1 Milliseconds (msec) | Standard Deviation 8.77 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QRS duration; Visit 4 (Week 39); n= 71 | 1.1 Milliseconds (msec) | Standard Deviation 7.1 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QRS duration; Visit 5 (Week 52); n= 67 | 0.9 Milliseconds (msec) | Standard Deviation 9.81 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QRS duration; Visit 6 (Week 69); n= 63 | 1.9 Milliseconds (msec) | Standard Deviation 8.56 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QRS duration; Visit 7 (Week 86); n= 55 | -0.4 Milliseconds (msec) | Standard Deviation 7.2 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QRS duration; Visit 8 (Week 104); n= 42 | 0.1 Milliseconds (msec) | Standard Deviation 6.4 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QRS duration; Visit 9 (Week 121); n= 38 | -0.7 Milliseconds (msec) | Standard Deviation 7.79 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QRS duration; Visit 10 (Week 138); n= 37 | -2.0 Milliseconds (msec) | Standard Deviation 7.85 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QRS duration; Visit 11 (Week 156); n= 30 | -3.3 Milliseconds (msec) | Standard Deviation 9.54 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QRS duration; Visit 12 (Week 173); n= 24 | -1.3 Milliseconds (msec) | Standard Deviation 9.04 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QRS duration; Visit 15 (Week 225); n= 5 | -2.9 Milliseconds (msec) | Standard Deviation 3.44 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QRS duration; Visit 17 (Week 260); n= 4 | -7.8 Milliseconds (msec) | Standard Deviation 5.19 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QRS duration; Visit 18 (Week 277); n= 2 | -4.5 Milliseconds (msec) | Standard Deviation 2.12 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QRS duration; withdrawal visit; n= 82 | -2.5 Milliseconds (msec) | Standard Deviation 9.49 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QRS duration; follow up visit; n= 59 | 0.0 Milliseconds (msec) | Standard Deviation 11.9 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | Uncorrected QT interval;Visit 1 (Screening); n= 85 | 10.1 Milliseconds (msec) | Standard Deviation 26.19 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | Uncorrected QT interval; Visit 2 (Week 13); n= 88 | 4.9 Milliseconds (msec) | Standard Deviation 23.43 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | Uncorrected QT interval; Visit 3 (Week 26); n= 78 | 7.9 Milliseconds (msec) | Standard Deviation 23.44 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | Uncorrected QT interval; Visit 8 (Week 104); n= 41 | 6.0 Milliseconds (msec) | Standard Deviation 26.77 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | Uncorrected QT interval; withdrawal visit; n= 80 | 5.2 Milliseconds (msec) | Standard Deviation 29.01 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | Uncorrected QT interval; follow up visit; n= 56 | 2.7 Milliseconds (msec) | Standard Deviation 28.41 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcB; Visit 1 (Screening); n= 85 | 5.0 Milliseconds (msec) | Standard Deviation 17.35 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcB; Visit 2 (Week 13); n= 88 | 3.2 Milliseconds (msec) | Standard Deviation 18.52 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcB; Visit 3 (Week 26); n= 78 | 4.0 Milliseconds (msec) | Standard Deviation 16.48 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcB; Visit 4 (Week 39); n= 69 | 6.0 Milliseconds (msec) | Standard Deviation 17.27 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcB; Visit 5 (Week 52); n= 65 | 5.8 Milliseconds (msec) | Standard Deviation 17.14 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcB; Visit 6 (Week 69); n= 61 | 6.8 Milliseconds (msec) | Standard Deviation 15.01 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcB; Visit 7 (Week 86); n= 53 | 4.3 Milliseconds (msec) | Standard Deviation 15.71 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcB; Visit 8 (Week 104); n= 41 | 2.5 Milliseconds (msec) | Standard Deviation 20.7 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcB; Visit 9 (Week 121); n= 37 | 4.9 Milliseconds (msec) | Standard Deviation 16.01 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcB; Visit 10 (Week 138); n= 36 | -2.8 Milliseconds (msec) | Standard Deviation 16.46 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcB; Visit 11 (Week 156); n= 29 | -0.3 Milliseconds (msec) | Standard Deviation 19.63 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcB; Visit 12 (Week 173); n= 23 | 4.2 Milliseconds (msec) | Standard Deviation 24.12 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcB; Visit 13 (Week 190); n= 19 | 3.9 Milliseconds (msec) | Standard Deviation 20.16 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcB; Visit 14 (Week 208); n= 10 | -1.6 Milliseconds (msec) | Standard Deviation 14.91 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcB; Visit 15 (Week 225); n= 5 | -1.9 Milliseconds (msec) | Standard Deviation 18.26 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcB; Visit 16 (Week 242); n= 4 | -9.8 Milliseconds (msec) | Standard Deviation 15.09 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcB; Visit 17 (Week 260); n= 4 | -2.0 Milliseconds (msec) | Standard Deviation 27.12 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcB; Visit 18 (Week 277); n= 2 | 4.5 Milliseconds (msec) | Standard Deviation 17.68 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcB; withdrawal visit; n= 80 | -0.7 Milliseconds (msec) | Standard Deviation 20.78 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcB; follow up visit; n= 56 | -1.0 Milliseconds (msec) | Standard Deviation 17.84 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcF; Visit 1 (Screening); n= 85 | 6.8 Milliseconds (msec) | Standard Deviation 16.11 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcF; Visit 2 (Week 13); n= 88 | 3.7 Milliseconds (msec) | Standard Deviation 15.74 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcF; Visit 3 (Week 26); n= 78 | 5.4 Milliseconds (msec) | Standard Deviation 15.01 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcF; Visit 4 (Week 39); n= 69 | 7.1 Milliseconds (msec) | Standard Deviation 16.58 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcF; Visit 5 (Week 52); n= 65 | 6.1 Milliseconds (msec) | Standard Deviation 14.92 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcF; Visit 6 (Week 69); n= 61 | 7.1 Milliseconds (msec) | Standard Deviation 14.47 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcF; Visit 7 (Week 86); n= 53 | 2.3 Milliseconds (msec) | Standard Deviation 16.04 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcF; Visit 8 (Week 104); n= 41 | 3.7 Milliseconds (msec) | Standard Deviation 19.31 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcF; Visit 9 (Week 121); n= 37 | 3.0 Milliseconds (msec) | Standard Deviation 12.9 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcF; Visit 10 (Week 138); n= 36 | -4.8 Milliseconds (msec) | Standard Deviation 18.22 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcF; Visit 11 (Week 156); n= 29 | -1.8 Milliseconds (msec) | Standard Deviation 21.86 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcF; Visit 12 (Week 173); n= 23 | 4.6 Milliseconds (msec) | Standard Deviation 17.51 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcF; Visit 13 (Week 190); n= 19 | 1.9 Milliseconds (msec) | Standard Deviation 17.47 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcF; Visit 14 (Week 208); n= 10 | -7.0 Milliseconds (msec) | Standard Deviation 14.99 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | Uncorrected QT interval; Visit 9 (Week 121); n= 37 | -0.5 Milliseconds (msec) | Standard Deviation 24.52 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcF; Visit 15 (Week 225); n= 5 | -1.6 Milliseconds (msec) | Standard Deviation 10.53 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcF; Visit 17 (Week 260); n= 4 | 5.3 Milliseconds (msec) | Standard Deviation 29.75 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcF; Visit 18 (Week 277); n= 2 | 2.0 Milliseconds (msec) | Standard Deviation 24.04 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcF; withdrawal visit; n= 80 | 1.3 Milliseconds (msec) | Standard Deviation 18.24 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | QTcF; follow up visit; n= 56 | 0.3 Milliseconds (msec) | Standard Deviation 15.49 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | RR interval; visit 1 (Screening); n= 89 | 27.9 Milliseconds (msec) | Standard Deviation 120.57 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | RR interval; visit 3 (Week 26); n= 80 | 20.5 Milliseconds (msec) | Standard Deviation 110.48 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | RR interval; visit 4 (Week 39); n= 71 | 22.4 Milliseconds (msec) | Standard Deviation 107.77 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | RR interval; visit 6 (Week 69); n= 63 | 6.2 Milliseconds (msec) | Standard Deviation 127.01 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | RR interval; visit 7 (Week 86); n= 56 | -18.5 Milliseconds (msec) | Standard Deviation 102.45 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | RR interval; visit 8 (Week 104); n= 42 | 23.7 Milliseconds (msec) | Standard Deviation 121.17 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | RR interval; visit 9 (Week 121); n= 38 | -17.5 Milliseconds (msec) | Standard Deviation 134.18 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | RR interval; visit 10 (Week 138); n= 37 | -19.6 Milliseconds (msec) | Standard Deviation 145.64 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | RR interval; visit 11 (Week 156); n= 30 | -16.0 Milliseconds (msec) | Standard Deviation 120.5 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | RR interval; visit 12 (Week 173); n= 24 | 12.9 Milliseconds (msec) | Standard Deviation 163.66 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | RR interval; visit 13 (Week 190); n= 19 | -19.5 Milliseconds (msec) | Standard Deviation 138.03 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | RR interval; visit 14 (Week 208); n= 10 | -70.7 Milliseconds (msec) | Standard Deviation 130.51 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | RR interval; visit 15 (Week 225); n= 5 | -2.8 Milliseconds (msec) | Standard Deviation 108.3 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | RR interval; visit 16 (Week 242); n= 4 | 56.6 Milliseconds (msec) | Standard Deviation 165.75 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | RR interval; visit 17 (Week 260); n= 4 | 83.5 Milliseconds (msec) | Standard Deviation 91.72 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | RR interval; visit 18 (Week 277); n= 2 | -30.0 Milliseconds (msec) | Standard Deviation 86.27 |
| Retigabine IR | Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval | RR interval; withdrawal visit; n= 83 | 29.1 Milliseconds (msec) | Standard Deviation 152.19 |
Primary
Change From Baseline in Electrocardiogram (ECG) Parameter Including HR
Single measurements of 12-lead ECG were obtained in supine position after at least 10 minutes of rest using an ECG machine to measure HR. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline and up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine IR | Change From Baseline in Electrocardiogram (ECG) Parameter Including HR | Visit 1 (Screening); n= 89 | -2.2 Beats per minute (bpm) | Standard Deviation 10.54 |
| Retigabine IR | Change From Baseline in Electrocardiogram (ECG) Parameter Including HR | Visit 3 (Week 26); n= 80 | -1.5 Beats per minute (bpm) | Standard Deviation 9.21 |
| Retigabine IR | Change From Baseline in Electrocardiogram (ECG) Parameter Including HR | Visit 8 (Week 104); n= 42 | -1.8 Beats per minute (bpm) | Standard Deviation 10.3 |
| Retigabine IR | Change From Baseline in Electrocardiogram (ECG) Parameter Including HR | Visit 9 (Week 121); n= 38 | 1.7 Beats per minute (bpm) | Standard Deviation 11.01 |
| Retigabine IR | Change From Baseline in Electrocardiogram (ECG) Parameter Including HR | Visit 11 (Week 156); n= 30 | 1.1 Beats per minute (bpm) | Standard Deviation 10.23 |
| Retigabine IR | Change From Baseline in Electrocardiogram (ECG) Parameter Including HR | Visit 12 (Week 173); n= 24 | -0.8 Beats per minute (bpm) | Standard Deviation 13.43 |
| Retigabine IR | Change From Baseline in Electrocardiogram (ECG) Parameter Including HR | Visit 13 (Week 190); n= 19 | 2.7 Beats per minute (bpm) | Standard Deviation 11.29 |
| Retigabine IR | Change From Baseline in Electrocardiogram (ECG) Parameter Including HR | Visit 18 (Week 277); n= 2 | 2.5 Beats per minute (bpm) | Standard Deviation 9.19 |
| Retigabine IR | Change From Baseline in Electrocardiogram (ECG) Parameter Including HR | Withdrawal visit; n= 83 | -1.8 Beats per minute (bpm) | Standard Deviation 11.49 |
| Retigabine IR | Change From Baseline in Electrocardiogram (ECG) Parameter Including HR | Visit 2 (Week 13); n= 90 | -0.6 Beats per minute (bpm) | Standard Deviation 9.77 |
| Retigabine IR | Change From Baseline in Electrocardiogram (ECG) Parameter Including HR | Visit 4 (Week 39); n= 71 | -1.7 Beats per minute (bpm) | Standard Deviation 8.72 |
| Retigabine IR | Change From Baseline in Electrocardiogram (ECG) Parameter Including HR | Visit 5 (Week 52); n= 67 | -0.6 Beats per minute (bpm) | Standard Deviation 10.3 |
| Retigabine IR | Change From Baseline in Electrocardiogram (ECG) Parameter Including HR | Visit 6 (Week 69); n= 63 | -0.2 Beats per minute (bpm) | Standard Deviation 9.96 |
| Retigabine IR | Change From Baseline in Electrocardiogram (ECG) Parameter Including HR | Visit 7 (Week 86); n= 56 | 1.6 Beats per minute (bpm) | Standard Deviation 8.89 |
| Retigabine IR | Change From Baseline in Electrocardiogram (ECG) Parameter Including HR | Visit 10 (Week 138); n= 37 | 1.6 Beats per minute (bpm) | Standard Deviation 12.17 |
| Retigabine IR | Change From Baseline in Electrocardiogram (ECG) Parameter Including HR | Visit 14 (Week 208); n= 10 | 5.6 Beats per minute (bpm) | Standard Deviation 10.41 |
| Retigabine IR | Change From Baseline in Electrocardiogram (ECG) Parameter Including HR | Visit 15 (Week 225); n= 5 | -0.2 Beats per minute (bpm) | Standard Deviation 8.04 |
| Retigabine IR | Change From Baseline in Electrocardiogram (ECG) Parameter Including HR | Visit 16 (Week 242); n= 4 | -4.3 Beats per minute (bpm) | Standard Deviation 13.3 |
| Retigabine IR | Change From Baseline in Electrocardiogram (ECG) Parameter Including HR | Visit 17 (Week 260); n= 4 | -7.3 Beats per minute (bpm) | Standard Deviation 6.95 |
| Retigabine IR | Change From Baseline in Electrocardiogram (ECG) Parameter Including HR | Follow up visit; n= 59 | -1.1 Beats per minute (bpm) | Standard Deviation 11.95 |
Primary
Change From Baseline in Hematocrit Levels
Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including hematocrit. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline and up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine IR | Change From Baseline in Hematocrit Levels | Visit 14 (Week 208); n= 10 | 0.0015 Proportion of red blood cells in blood | Standard Deviation 0.03213 |
| Retigabine IR | Change From Baseline in Hematocrit Levels | Visit 1 (Screening); n= 85 | -0.0080 Proportion of red blood cells in blood | Standard Deviation 0.02259 |
| Retigabine IR | Change From Baseline in Hematocrit Levels | Visit 2 (Week 13); n= 89 | -0.0087 Proportion of red blood cells in blood | Standard Deviation 0.02508 |
| Retigabine IR | Change From Baseline in Hematocrit Levels | Visit 3 (Week 26); n= 74 | -0.0066 Proportion of red blood cells in blood | Standard Deviation 0.02651 |
| Retigabine IR | Change From Baseline in Hematocrit Levels | Visit 4 (Week 39); n= 69 | -0.0030 Proportion of red blood cells in blood | Standard Deviation 0.02861 |
| Retigabine IR | Change From Baseline in Hematocrit Levels | Visit 5 (Week 52); n= 64 | -0.0020 Proportion of red blood cells in blood | Standard Deviation 0.02985 |
| Retigabine IR | Change From Baseline in Hematocrit Levels | Visit 6 (Week 69); n= 62 | -0.0020 Proportion of red blood cells in blood | Standard Deviation 0.02821 |
| Retigabine IR | Change From Baseline in Hematocrit Levels | Visit 7 (Week 86); n= 55 | 0.0063 Proportion of red blood cells in blood | Standard Deviation 0.02627 |
| Retigabine IR | Change From Baseline in Hematocrit Levels | Visit 8 (Week 104); n= 41 | 0.0103 Proportion of red blood cells in blood | Standard Deviation 0.02839 |
| Retigabine IR | Change From Baseline in Hematocrit Levels | Visit 9 (Week 121); n= 36 | 0.0053 Proportion of red blood cells in blood | Standard Deviation 0.02819 |
| Retigabine IR | Change From Baseline in Hematocrit Levels | Visit 10 (Week 138); n= 36 | 0.0129 Proportion of red blood cells in blood | Standard Deviation 0.04091 |
| Retigabine IR | Change From Baseline in Hematocrit Levels | Visit 11 (Week 156); n= 31 | 0.0025 Proportion of red blood cells in blood | Standard Deviation 0.02755 |
| Retigabine IR | Change From Baseline in Hematocrit Levels | Visit 12 (Week 173); n= 24 | 0.0070 Proportion of red blood cells in blood | Standard Deviation 0.03167 |
| Retigabine IR | Change From Baseline in Hematocrit Levels | Visit 13 (Week 190); n= 18 | 0.0061 Proportion of red blood cells in blood | Standard Deviation 0.02857 |
| Retigabine IR | Change From Baseline in Hematocrit Levels | Visit 15 (Week 225); n= 4 | 0.0050 Proportion of red blood cells in blood | Standard Deviation 0.01857 |
| Retigabine IR | Change From Baseline in Hematocrit Levels | Visit 16 (Week 242); n= 4 | -0.0097 Proportion of red blood cells in blood | Standard Deviation 0.02017 |
| Retigabine IR | Change From Baseline in Hematocrit Levels | Visit 17 (Week 260); n= 4 | -0.0040 Proportion of red blood cells in blood | Standard Deviation 0.00841 |
| Retigabine IR | Change From Baseline in Hematocrit Levels | Visit 18 (Week 277); n= 2 | -0.0270 Proportion of red blood cells in blood | Standard Deviation 0.03677 |
| Retigabine IR | Change From Baseline in Hematocrit Levels | Withdrawal visit; n= 79 | 0.0034 Proportion of red blood cells in blood | Standard Deviation 0.02926 |
| Retigabine IR | Change From Baseline in Hematocrit Levels | Follow up visit; n= 59 | 0.0039 Proportion of red blood cells in blood | Standard Deviation 0.03501 |
Primary
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels
Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including hemoglobin and MCHC. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline and up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; visit 1 (Screening); n= 85 | -3.5 G/L | Standard Deviation 6.75 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; visit 2 (Week 13); n= 89 | -2.4 G/L | Standard Deviation 7.87 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; visit 3 (Week 26); n= 74 | -2.7 G/L | Standard Deviation 7.59 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; visit 4 (Week 39); n= 69 | -2.9 G/L | Standard Deviation 9.09 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; visit 5 (Week 52); n= 64 | -2.9 G/L | Standard Deviation 9.51 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; visit 6 (Week 69); n= 62 | -2.5 G/L | Standard Deviation 9.83 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; visit 7 (Week 86); n= 55 | -0.4 G/L | Standard Deviation 8.75 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; visit 8 (Week 104); n= 41 | -0.7 G/L | Standard Deviation 8.35 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; visit 9 (Week 121); n= 36 | -1.4 G/L | Standard Deviation 8.68 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; visit 10 (Week 138); n= 36 | 0.1 G/L | Standard Deviation 12.38 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; visit 11 (Week 156); n= 31 | -3.4 G/L | Standard Deviation 9.73 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; visit 12 (Week 173); n= 24 | -2.2 G/L | Standard Deviation 9.46 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; visit 13 (Week 190); n= 18 | -4.3 G/L | Standard Deviation 9.11 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; visit 14 (Week 208); n= 10 | -8.0 G/L | Standard Deviation 10.02 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; visit 15 (Week 225); n= 4 | -6.0 G/L | Standard Deviation 4.76 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; visit 16 (Week 242); n= 4 | -9.5 G/L | Standard Deviation 6.66 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; visit 17 (Week 260); n= 4 | -8.0 G/L | Standard Deviation 6.16 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; visit 18 (Week 277); n= 2 | -10.5 G/L | Standard Deviation 7.78 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; withdrawal visit; n= 79 | -1.7 G/L | Standard Deviation 9.69 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; follow up visit; n= 59 | -2.3 G/L | Standard Deviation 11.53 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; visit 1 (Screening); n= 85 | -2.1 G/L | Standard Deviation 12.61 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; visit 2 (Week 13); n= 89 | 1.4 G/L | Standard Deviation 12.22 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; visit 3 (Week 26); n= 74 | -1.1 G/L | Standard Deviation 11.5 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; visit 4 (Week 39); n= 69 | -4.6 G/L | Standard Deviation 12.75 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; visit 5 (Week 52); n= 64 | -5.4 G/L | Standard Deviation 13.35 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; visit 6 (Week 69); n= 62 | -4.8 G/L | Standard Deviation 11.64 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; visit 7 (Week 86); n= 55 | -5.8 G/L | Standard Deviation 9.79 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; visit 8 (Week 104); n= 41 | -9.1 G/L | Standard Deviation 10.62 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; visit 9 (Week 121); n= 36 | -6.9 G/L | Standard Deviation 11.74 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; visit 10 (Week 138); n= 36 | -9.6 G/L | Standard Deviation 9.87 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; visit 11 (Week 156); n= 31 | -10.1 G/L | Standard Deviation 11.76 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; visit 12 (Week 173); n= 24 | -10.7 G/L | Standard Deviation 9.45 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; visit 13 (Week 190); n= 18 | -15.2 G/L | Standard Deviation 9.24 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; visit 14 (Week 208); n= 10 | -21.5 G/L | Standard Deviation 10.48 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; visit 15 (Week 225); n= 4 | -16.3 G/L | Standard Deviation 7.59 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; visit 16 (Week 242); n= 4 | -14.5 G/L | Standard Deviation 5.51 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; visit 17 (Week 260); n= 4 | -16.0 G/L | Standard Deviation 8.25 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; visit 18 (Week 277); n= 2 | -4.5 G/L | Standard Deviation 9.19 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; withdrawal visit; n= 79 | -6.8 G/L | Standard Deviation 9.61 |
| Retigabine IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; follow up visit; n= 59 | -8.6 G/L | Standard Deviation 10.18 |
Primary
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels
Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including MCH. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline and up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Visit 1 (Screening); n= 85 | -0.17 Picograms (Pg) | Standard Deviation 0.91 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Visit 2 (Week 13); n= 89 | -0.33 Picograms (Pg) | Standard Deviation 1.058 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Visit 3 (Week 26); n= 74 | -0.47 Picograms (Pg) | Standard Deviation 0.809 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Visit 4 (Week 39); n= 69 | -0.83 Picograms (Pg) | Standard Deviation 1.238 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Visit 5 (Week 52); n= 64 | -0.77 Picograms (Pg) | Standard Deviation 1.087 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Visit 6 (Week 69); n= 62 | -0.91 Picograms (Pg) | Standard Deviation 1.317 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Visit 7 (Week 86); n= 55 | -0.99 Picograms (Pg) | Standard Deviation 1.227 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Visit 8 (Week 104); n= 41 | -1.17 Picograms (Pg) | Standard Deviation 1.503 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Visit 9 (Week 121); n= 36 | -1.11 Picograms (Pg) | Standard Deviation 1.551 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Visit 10 (Week 138); n= 36 | -1.28 Picograms (Pg) | Standard Deviation 1.282 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Visit 11 (Week 156); n= 31 | -1.44 Picograms (Pg) | Standard Deviation 1.065 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Visit 12 (Week 173); n= 24 | -1.78 Picograms (Pg) | Standard Deviation 1.38 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Visit 13 (Week 190); n= 18 | -1.90 Picograms (Pg) | Standard Deviation 1.251 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Visit 14 (Week 208); n= 10 | -2.19 Picograms (Pg) | Standard Deviation 1.883 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Visit 15 (Week 225); n= 4 | -2.00 Picograms (Pg) | Standard Deviation 1.291 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Visit 16 (Week 242); n= 4 | -2.50 Picograms (Pg) | Standard Deviation 1.669 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Visit 17 (Week 260); n= 4 | -1.83 Picograms (Pg) | Standard Deviation 1.382 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Visit 18 (Week 277); n= 2 | -2.65 Picograms (Pg) | Standard Deviation 0.354 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Withdrawal visit; n= 79 | -1.11 Picograms (Pg) | Standard Deviation 1.305 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Follow up visit; n= 59 | -1.08 Picograms (Pg) | Standard Deviation 1.437 |
Primary
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels
Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including MCV and MPV. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline and up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MCV (Screening); Visit 1; n= 85 | 0.0 Femtoliter (fL) | Standard Deviation 3.55 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MCV; Visit 2 (Week 13); n= 89 | -1.5 Femtoliter (fL) | Standard Deviation 3.63 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MCV; Visit 3 (Week 26); n= 74 | -1.0 Femtoliter (fL) | Standard Deviation 3.32 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MCV; Visit 4 (Week 39); n= 69 | -1.2 Femtoliter (fL) | Standard Deviation 3.62 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MCV; Visit 5 (Week 52); n= 64 | -0.8 Femtoliter (fL) | Standard Deviation 3.71 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MCV; Visit 6 (Week 69); n= 62 | -1.4 Femtoliter (fL) | Standard Deviation 4.29 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MCV; Visit 7 (Week 86); n= 55 | -1.2 Femtoliter (fL) | Standard Deviation 3.56 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MCV; Visit 8 (Week 104); n= 41 | -0.9 Femtoliter (fL) | Standard Deviation 4.75 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MCV; Visit 9 (Week 121); n= 36 | -1.4 Femtoliter (fL) | Standard Deviation 4 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MCV; Visit 10 (Week 138); n= 36 | -1.1 Femtoliter (fL) | Standard Deviation 4.3 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MCV; Visit 11 (Week 156); n= 31 | -1.5 Femtoliter (fL) | Standard Deviation 4.18 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MCV; Visit 12 (Week 173); n= 24 | -2.5 Femtoliter (fL) | Standard Deviation 4.64 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MCV; Visit 13 (Week 190); n= 18 | -1.2 Femtoliter (fL) | Standard Deviation 4.4 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MCV; Visit 14 (Week 208); n= 10 | -0.9 Femtoliter (fL) | Standard Deviation 4.48 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MCV; Visit 15 (Week 225); n= 4 | -1.5 Femtoliter (fL) | Standard Deviation 1.73 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MCV; Visit 16 (Week 242); n= 4 | -4.0 Femtoliter (fL) | Standard Deviation 3.92 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MCV; Visit 17 (Week 260); n= 4 | -1.3 Femtoliter (fL) | Standard Deviation 2.63 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MCV; Visit 18 (Week 277); n= 2 | -7.0 Femtoliter (fL) | Standard Deviation 4.24 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MCV; Withdrawal visit; n= 79 | -1.4 Femtoliter (fL) | Standard Deviation 4.14 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MCV; Follow up visit; n= 59 | -0.9 Femtoliter (fL) | Standard Deviation 4.39 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MPV; visit 1 (Screening); n= 84 | -0.12 Femtoliter (fL) | Standard Deviation 0.715 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MPV: visit 2 (Week 13); n= 86 | -0.10 Femtoliter (fL) | Standard Deviation 0.756 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MPV: visit 3 (Week 26); n= 71 | -0.08 Femtoliter (fL) | Standard Deviation 0.612 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MPV; visit 4 (Week 39); n= 67 | -0.17 Femtoliter (fL) | Standard Deviation 0.823 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MPV; visit 5 (Week 52); n= 61 | -0.06 Femtoliter (fL) | Standard Deviation 0.746 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MPV; visit 6 (Week 69); n= 58 | -0.03 Femtoliter (fL) | Standard Deviation 0.654 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MPV; visit 7 (Week 86); n= 53 | 0.12 Femtoliter (fL) | Standard Deviation 0.786 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MPV; visit 8 (Week 104); n= 38 | 0.01 Femtoliter (fL) | Standard Deviation 0.902 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MPV: visit 9 (Week 121); n= 35 | 0.13 Femtoliter (fL) | Standard Deviation 0.788 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MPV; visit 10 (Week 138); n= 34 | 0.06 Femtoliter (fL) | Standard Deviation 0.773 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MPV; visit 11 (Week 156); n= 29 | 0.14 Femtoliter (fL) | Standard Deviation 0.728 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MPV: visit 12 (Week 173); n= 24 | 0.04 Femtoliter (fL) | Standard Deviation 0.944 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MPV; visit 13 (Week 190); n= 17 | -0.09 Femtoliter (fL) | Standard Deviation 0.766 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MPV; visit 14 (Week 208); n= 10 | -0.37 Femtoliter (fL) | Standard Deviation 0.455 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MPV; visit 15 (Week 225); n= 4 | -0.33 Femtoliter (fL) | Standard Deviation 1.053 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MPV; visit 16 (Week 242); n= 4 | -0.75 Femtoliter (fL) | Standard Deviation 0.802 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MPV; visit 17 (Week 260); n= 4 | -0.17 Femtoliter (fL) | Standard Deviation 0.67 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MPV; visit 18 (Week 277); n= 2 | -1.15 Femtoliter (fL) | Standard Deviation 0.071 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MPV; withdrawal visit; n= 78 | 0.19 Femtoliter (fL) | Standard Deviation 0.902 |
| Retigabine IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels | MPV; follow up visit; n= 57 | 0.12 Femtoliter (fL) | Standard Deviation 0.859 |
Primary
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels
Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including percent basophils, eosinophils, lymphocytes, monocytes, neutrophils and RDW. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline and up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | RDW; visit 1 (Screening); n= 85 | 0.41 Percent of blood components | Standard Deviation 1.398 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | RDW; visit 2 (Week 13); n= 89 | -0.07 Percent of blood components | Standard Deviation 1.532 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | RDW; visit 3 (Week 26); n= 74 | 0.05 Percent of blood components | Standard Deviation 0.924 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | RDW; visit 4 (Week 39); n= 69 | 0.47 Percent of blood components | Standard Deviation 1.637 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | RDW; visit 5 (Week 52); n= 64 | 0.35 Percent of blood components | Standard Deviation 1.598 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | RDW; visit 6 (Week 69); n= 62 | 0.05 Percent of blood components | Standard Deviation 1.437 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | RDW; visit 7 (Week 86); n= 55 | 0.05 Percent of blood components | Standard Deviation 1.109 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | RDW; visit 8 (Week 104); n= 41 | 0.32 Percent of blood components | Standard Deviation 1.386 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | RDW; visit 9 (Week 121); n= 36 | -0.19 Percent of blood components | Standard Deviation 1.084 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | RDW; visit 10 (Week 138); n= 36 | 0.22 Percent of blood components | Standard Deviation 0.885 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | RDW; visit 11 (Week 156); n= 31 | 0.94 Percent of blood components | Standard Deviation 1.76 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | RDW; visit 12 (Week 173); n= 24 | 0.41 Percent of blood components | Standard Deviation 1.292 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | RDW; visit 13 (Week 190); n= 18 | 0.88 Percent of blood components | Standard Deviation 0.919 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | RDW; visit 14 (Week 208); n= 10 | 1.98 Percent of blood components | Standard Deviation 1.605 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | RDW; visit 15 (Week 225); n= 4 | 0.28 Percent of blood components | Standard Deviation 0.55 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | RDW; visit 16 (Week 242); n= 4 | 3.95 Percent of blood components | Standard Deviation 6.855 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | RDW; visit 17 (Week 260); n= 4 | 2.50 Percent of blood components | Standard Deviation 2.202 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | RDW; visit 18 (Week 277); n= 2 | 2.05 Percent of blood components | Standard Deviation 0.495 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | RDW; withdrawal visit; n= 79 | 0.10 Percent of blood components | Standard Deviation 1.097 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | RDW; follow up visit; n= 59 | 0.27 Percent of blood components | Standard Deviation 1.235 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent basophils; visit 1 (Screening); n= 84 | -0.00 Percent of blood components | Standard Deviation 0.312 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent basophils; visit 2 (Week 13); n= 85 | -0.06 Percent of blood components | Standard Deviation 0.243 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent basophils; visit 3 (Week 26); n= 71 | -0.03 Percent of blood components | Standard Deviation 0.305 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent basophils; visit 4 (Week 39); n= 65 | 0.07 Percent of blood components | Standard Deviation 0.393 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent basophils; visit 5 (Week 52); n= 60 | 0.04 Percent of blood components | Standard Deviation 0.279 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent basophils; visit 6 (Week 69); n= 58 | -0.02 Percent of blood components | Standard Deviation 0.315 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent basophils; visit 7 (Week 86); n= 53 | -0.02 Percent of blood components | Standard Deviation 0.302 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent basophils; visit 8 (Week 104); n= 36 | 0.11 Percent of blood components | Standard Deviation 0.271 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent basophils; visit 9 (Week 121); n= 35 | -0.06 Percent of blood components | Standard Deviation 0.239 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent basophils; visit 10 (Week 138); n= 33 | -0.02 Percent of blood components | Standard Deviation 0.255 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent basophils; visit 11 (Week 156); n= 29 | -0.00 Percent of blood components | Standard Deviation 0.267 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent basophils; visit 12 (Week 173); n= 24 | -0.06 Percent of blood components | Standard Deviation 0.253 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent basophils; visit 13 (Week 190); n= 17 | -0.01 Percent of blood components | Standard Deviation 0.339 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent basophils; visit 14 (Week 208); n= 10 | -0.03 Percent of blood components | Standard Deviation 0.283 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent basophils; visit 15 (Week 225); n= 4 | 0.00 Percent of blood components | Standard Deviation 0.216 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent basophils; visit 16 (Week 242); n= 4 | 0.03 Percent of blood components | Standard Deviation 0.126 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent basophils; visit 17 (Week 260); n= 4 | 0.03 Percent of blood components | Standard Deviation 0.05 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent basophils; visit 18 (Week 277); n= 2 | 0.25 Percent of blood components | Standard Deviation 0.212 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent basophils; withdrawal visit; n= 78 | 0.01 Percent of blood components | Standard Deviation 0.291 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent basophils; follow up visit; n= 56 | -0.13 Percent of blood components | Standard Deviation 0.304 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent eosinophils; visit 1 (Screening); n= 84 | -0.06 Percent of blood components | Standard Deviation 1.745 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent eosinophils; visit 2 (Week 13); n= 85 | -0.00 Percent of blood components | Standard Deviation 3.214 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent eosinophils; visit 3 (Week 26); n= 71 | -0.29 Percent of blood components | Standard Deviation 2.773 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent eosinophils; visit 4 (Week 39); n= 65 | -0.44 Percent of blood components | Standard Deviation 3.339 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent eosinophils; visit 5 (Week 52); n= 60 | -0.77 Percent of blood components | Standard Deviation 4.046 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent eosinophils; visit 6 (Week 69); n= 58 | -0.26 Percent of blood components | Standard Deviation 2.63 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent eosinophils; visit 7 (Week 86); n= 53 | -0.30 Percent of blood components | Standard Deviation 2.634 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent eosinophils; visit 8 (Week 104); n= 36 | -0.04 Percent of blood components | Standard Deviation 3.003 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent eosinophils; visit 9 (Week 121); n= 35 | -0.47 Percent of blood components | Standard Deviation 2.653 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent eosinophils; visit 10 (Week 138); n= 33 | -0.92 Percent of blood components | Standard Deviation 2.942 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent eosinophils; visit 11 (Week 156); n= 29 | -0.79 Percent of blood components | Standard Deviation 2.484 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent eosinophils; visit 12 (Week 173); n= 24 | -0.70 Percent of blood components | Standard Deviation 5.548 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent eosinophils; visit 13 (Week 190); n= 17 | -1.38 Percent of blood components | Standard Deviation 5.539 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent eosinophils; visit 14 (Week 208); n= 10 | -2.49 Percent of blood components | Standard Deviation 2.975 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent eosinophils; visit 15 (Week 225); n= 4 | -1.53 Percent of blood components | Standard Deviation 1.565 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent eosinophils; visit 16 (Week 242); n= 4 | -0.43 Percent of blood components | Standard Deviation 1.628 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent eosinophils; visit 17 (Week 260); n= 4 | 0.00 Percent of blood components | Standard Deviation 1.359 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent eosinophils; visit 18 (Week 277); n= 2 | 1.65 Percent of blood components | Standard Deviation 0.636 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent eosinophils; withdrawal visit; n= 78 | -0.83 Percent of blood components | Standard Deviation 3.466 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent eosinophils; follow up visit; n= 56 | -1.30 Percent of blood components | Standard Deviation 3.804 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent lymphocytes; visit 1 (Screening); n= 84 | -2.21 Percent of blood components | Standard Deviation 8.44 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent lymphocytes; visit 2 (Week 13); n= 85 | -0.40 Percent of blood components | Standard Deviation 9.55 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent lymphocytes; visit 3 (Week 26); n= 71 | -1.14 Percent of blood components | Standard Deviation 10.82 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent lymphocytes; visit 4 (Week 39); n= 65 | 0.27 Percent of blood components | Standard Deviation 9.306 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent lymphocytes; visit 5 (Week 52); n= 60 | -2.58 Percent of blood components | Standard Deviation 11.216 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent lymphocytes; visit 6 (Week 69); n= 58 | -1.26 Percent of blood components | Standard Deviation 8.119 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent lymphocytes; visit 7 (Week 86); n= 53 | -0.53 Percent of blood components | Standard Deviation 11.226 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent lymphocytes; visit 8 (Week 104); n= 36 | 0.69 Percent of blood components | Standard Deviation 9.013 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent lymphocytes; visit 9 (Week 121); n= 35 | -2.27 Percent of blood components | Standard Deviation 11.733 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent lymphocytes; visit 10 (Week 138); n= 33 | -3.91 Percent of blood components | Standard Deviation 8.96 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent lymphocytes; visit 11 (Week 156); n= 29 | -4.52 Percent of blood components | Standard Deviation 9.015 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent lymphocytes; visit 12 (Week 173); n= 24 | -3.19 Percent of blood components | Standard Deviation 9.398 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent lymphocytes; visit 13 (Week 190); n= 17 | -4.73 Percent of blood components | Standard Deviation 12.168 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent lymphocytes; visit 14 (Week 208); n= 10 | -3.72 Percent of blood components | Standard Deviation 5.911 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent lymphocytes; visit 15 (Week 225); n= 4 | -6.58 Percent of blood components | Standard Deviation 3.848 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent lymphocytes; visit 16 (Week 242); n= 4 | -3.88 Percent of blood components | Standard Deviation 10.16 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent lymphocytes; visit 17 (Week 260); n= 4 | -5.85 Percent of blood components | Standard Deviation 4.886 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent lymphocytes; visit 18 (Week 277); n= 2 | -8.10 Percent of blood components | Standard Deviation 3.818 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent lymphocytes; withdrawal visit; n= 78 | -2.60 Percent of blood components | Standard Deviation 10.978 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent lymphocytes; follow up visit; n= 56 | -0.81 Percent of blood components | Standard Deviation 12.709 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent monocytes; visit 1 (Screening); n= 84 | -0.33 Percent of blood components | Standard Deviation 3.048 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent monocytes; visit 2 (Week 13); n= 85 | 0.27 Percent of blood components | Standard Deviation 2.72 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent monocytes; visit 3 (Week 26); n= 71 | 0.86 Percent of blood components | Standard Deviation 3.274 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent monocytes; visit 4 (Week 39); n= 65 | 0.76 Percent of blood components | Standard Deviation 3.286 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent monocytes; visit 5 (Week 52); n= 60 | -0.01 Percent of blood components | Standard Deviation 3.058 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent monocytes; visit 6 (Week 69); n= 58 | 0.64 Percent of blood components | Standard Deviation 2.834 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent monocytes; visit 7 (Week 86); n= 53 | 0.94 Percent of blood components | Standard Deviation 3.148 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent monocytes; visit 8 (Week 104); n= 36 | 0.04 Percent of blood components | Standard Deviation 3.458 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent monocytes; visit 9 (Week 121); n= 35 | -0.11 Percent of blood components | Standard Deviation 2.895 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent monocytes; visit 10 (Week 138); n= 33 | 0.15 Percent of blood components | Standard Deviation 3.16 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent monocytes; visit 11 (Week 156); n= 29 | -0.27 Percent of blood components | Standard Deviation 3.007 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent monocytes; visit 12 (Week 173); n= 24 | -0.44 Percent of blood components | Standard Deviation 2.687 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent monocytes; visit 13 (Week 190); n= 17 | -1.43 Percent of blood components | Standard Deviation 2.909 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent monocytes; visit 14 (Week 208); n= 10 | -0.71 Percent of blood components | Standard Deviation 5.153 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent monocytes; visit 15 (Week 225); n= 4 | 1.08 Percent of blood components | Standard Deviation 1.09 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent monocytes; visit 16 (Week 242); n= 4 | 1.25 Percent of blood components | Standard Deviation 1.686 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent monocytes; visit 17 (Week 260); n= 4 | 2.03 Percent of blood components | Standard Deviation 2.219 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent monocytes; visit 18 (Week 277); n= 2 | 4.20 Percent of blood components | Standard Deviation 2.687 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent monocytes; withdrawal visit; n= 78 | 0.48 Percent of blood components | Standard Deviation 3.355 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent monocytes; follow up visit; n= 56 | -0.35 Percent of blood components | Standard Deviation 3.293 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent neutrophils; visit 1 (Screening); n= 84 | 2.60 Percent of blood components | Standard Deviation 11.021 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent neutrophils; visit 2 (Week 13); n= 85 | 0.19 Percent of blood components | Standard Deviation 11.584 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent neutrophils; visit 3 (Week 26); n= 71 | 0.60 Percent of blood components | Standard Deviation 12.994 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent neutrophils; visit 4 (Week 39); n= 65 | -0.66 Percent of blood components | Standard Deviation 11.81 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent neutrophils; visit 5 (Week 52); n= 60 | 3.31 Percent of blood components | Standard Deviation 14.222 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent neutrophils; visit 6 (Week 69); n= 58 | 0.90 Percent of blood components | Standard Deviation 10.552 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent neutrophils; visit 7 (Week 86); n= 53 | -0.09 Percent of blood components | Standard Deviation 14.427 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent neutrophils; visit 8 (Week 104); n= 37 | -0.81 Percent of blood components | Standard Deviation 11.595 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent neutrophils; visit 9 (Week 121); n= 35 | 2.91 Percent of blood components | Standard Deviation 14.604 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent neutrophils; visit 10 (Week 138); n= 33 | 4.70 Percent of blood components | Standard Deviation 12.464 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent neutrophils; visit 11 (Week 156); n= 29 | 5.58 Percent of blood components | Standard Deviation 10.691 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent neutrophils; visit 12 (Week 173); n= 24 | 4.39 Percent of blood components | Standard Deviation 13.509 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent neutrophils; visit 13 (Week 190); n= 17 | 7.55 Percent of blood components | Standard Deviation 16.056 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent neutrophils; visit 14 (Week 208); n= 10 | 6.95 Percent of blood components | Standard Deviation 7.643 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent neutrophils; visit 15 (Week 225); n= 4 | 7.03 Percent of blood components | Standard Deviation 5.9 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent neutrophils; visit 16 (Week 242); n= 4 | 3.03 Percent of blood components | Standard Deviation 10.46 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent neutrophils; visit 17 (Week 260); n= 4 | 3.80 Percent of blood components | Standard Deviation 3.99 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent neutrophils; visit 18 (Week 277); n= 2 | 2.00 Percent of blood components | Standard Deviation 7.354 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent neutrophils; withdrawal visit; n= 78 | 2.94 Percent of blood components | Standard Deviation 13.146 |
| Retigabine IR | Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels | Percent neutrophils; follow up visit; n= 56 | 2.58 Percent of blood components | Standard Deviation 14.68 |
Primary
Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Urine Volume
The PVR bladder ultrasound was used to assess urinary retention. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline and up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine IR | Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Urine Volume | Visit 3 (Week 26); n= 77 | -6.0 Milliliter (mL) | Standard Deviation 24.73 |
| Retigabine IR | Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Urine Volume | Visit 5 (Week 52); n= 64 | 2.7 Milliliter (mL) | Standard Deviation 49.2 |
| Retigabine IR | Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Urine Volume | Visit 8 (Week 104); n= 40 | 3.9 Milliliter (mL) | Standard Deviation 49.03 |
| Retigabine IR | Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Urine Volume | Visit 11 (Week 156); n= 25 | 2.0 Milliliter (mL) | Standard Deviation 18.4 |
| Retigabine IR | Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Urine Volume | Visit 14 (Week 208); n= 10 | -16.0 Milliliter (mL) | Standard Deviation 21.33 |
| Retigabine IR | Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Urine Volume | Visit 17 (Week 260); n= 4 | -23.3 Milliliter (mL) | Standard Deviation 25 |
| Retigabine IR | Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Urine Volume | Withdrawal visit; n= 67 | -7.6 Milliliter (mL) | Standard Deviation 30.39 |
Primary
Change From Baseline in RBC Count
Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including RBC count. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine IR | Change From Baseline in RBC Count | Visit 1 (Screening); n= 85 | -0.10 Tetra cells per liter (TI/L) | Standard Deviation 0.212 |
| Retigabine IR | Change From Baseline in RBC Count | Visit 2 (Week 13); n= 89 | -0.03 Tetra cells per liter (TI/L) | Standard Deviation 0.255 |
| Retigabine IR | Change From Baseline in RBC Count | Visit 3 (Week 26); n= 74 | -0.03 Tetra cells per liter (TI/L) | Standard Deviation 0.24 |
| Retigabine IR | Change From Baseline in RBC Count | Visit 4 (Week 39); n= 69 | 0.01 Tetra cells per liter (TI/L) | Standard Deviation 0.272 |
| Retigabine IR | Change From Baseline in RBC Count | Visit 5 (Week 52); n= 64 | 0.00 Tetra cells per liter (TI/L) | Standard Deviation 0.311 |
| Retigabine IR | Change From Baseline in RBC Count | Visit 6 (Week 69); n= 62 | 0.04 Tetra cells per liter (TI/L) | Standard Deviation 0.3 |
| Retigabine IR | Change From Baseline in RBC Count | Visit 7 (Week 86); n= 55 | 0.12 Tetra cells per liter (TI/L) | Standard Deviation 0.26 |
| Retigabine IR | Change From Baseline in RBC Count | Visit 8 (Week 104); n= 41 | 0.14 Tetra cells per liter (TI/L) | Standard Deviation 0.28 |
| Retigabine IR | Change From Baseline in RBC Count | Visit 9 (Week 121); n= 36 | 0.11 Tetra cells per liter (TI/L) | Standard Deviation 0.299 |
| Retigabine IR | Change From Baseline in RBC Count | Visit 10 (Week 138); n= 36 | 0.19 Tetra cells per liter (TI/L) | Standard Deviation 0.445 |
| Retigabine IR | Change From Baseline in RBC Count | Visit 11 (Week 156); n= 31 | 0.09 Tetra cells per liter (TI/L) | Standard Deviation 0.344 |
| Retigabine IR | Change From Baseline in RBC Count | Visit 12 (Week 173); n= 24 | 0.18 Tetra cells per liter (TI/L) | Standard Deviation 0.385 |
| Retigabine IR | Change From Baseline in RBC Count | Visit 13 (Week 190); n= 18 | 0.12 Tetra cells per liter (TI/L) | Standard Deviation 0.343 |
| Retigabine IR | Change From Baseline in RBC Count | Visit 14 (Week 208); n= 10 | 0.05 Tetra cells per liter (TI/L) | Standard Deviation 0.366 |
| Retigabine IR | Change From Baseline in RBC Count | Visit 15 (Week 225); n= 4 | 0.13 Tetra cells per liter (TI/L) | Standard Deviation 0.206 |
| Retigabine IR | Change From Baseline in RBC Count | Visit 16 (Week 242); n= 4 | 0.10 Tetra cells per liter (TI/L) | Standard Deviation 0.216 |
| Retigabine IR | Change From Baseline in RBC Count | Visit 17 (Week 260); n= 4 | 0.00 Tetra cells per liter (TI/L) | Standard Deviation 0.082 |
| Retigabine IR | Change From Baseline in RBC Count | Visit 18 (Week 277); n= 2 | 0.05 Tetra cells per liter (TI/L) | Standard Deviation 0.212 |
| Retigabine IR | Change From Baseline in RBC Count | Withdrawal visit; n= 79 | 0.10 Tetra cells per liter (TI/L) | Standard Deviation 0.327 |
| Retigabine IR | Change From Baseline in RBC Count | Follow up visit; n= 59 | 0.07 Tetra cells per liter (TI/L) | Standard Deviation 0.409 |
Primary
Change From Baseline in Urine Albumin Creatinine Ratio
Urine samples were collected from participants for evaluation of change from Baseline in urinalysis parameters including albumin creatinine ratio. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline and up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine IR | Change From Baseline in Urine Albumin Creatinine Ratio | Visit 13 (Week 190); n= 10 | -0.59 Mg of urine albumin/ mmol of creatinine | Standard Deviation 1.748 |
| Retigabine IR | Change From Baseline in Urine Albumin Creatinine Ratio | Visit 1 (Screening); n= 39 | -0.57 Mg of urine albumin/ mmol of creatinine | Standard Deviation 3.573 |
| Retigabine IR | Change From Baseline in Urine Albumin Creatinine Ratio | Visit 2 (Week 13); n= 72 | -0.07 Mg of urine albumin/ mmol of creatinine | Standard Deviation 3.172 |
| Retigabine IR | Change From Baseline in Urine Albumin Creatinine Ratio | Visit 3 (Week 26); n= 54 | 0.15 Mg of urine albumin/ mmol of creatinine | Standard Deviation 3.678 |
| Retigabine IR | Change From Baseline in Urine Albumin Creatinine Ratio | Visit 4 (Week 39); n= 53 | -0.64 Mg of urine albumin/ mmol of creatinine | Standard Deviation 3.241 |
| Retigabine IR | Change From Baseline in Urine Albumin Creatinine Ratio | Visit 5 (Week 52); n= 52 | -0.69 Mg of urine albumin/ mmol of creatinine | Standard Deviation 3.065 |
| Retigabine IR | Change From Baseline in Urine Albumin Creatinine Ratio | Visit 6 (Week 69); n= 46 | -0.53 Mg of urine albumin/ mmol of creatinine | Standard Deviation 3.489 |
| Retigabine IR | Change From Baseline in Urine Albumin Creatinine Ratio | Visit 7 (Week 86); n= 47 | 0.07 Mg of urine albumin/ mmol of creatinine | Standard Deviation 6.062 |
| Retigabine IR | Change From Baseline in Urine Albumin Creatinine Ratio | Visit 8 (Week 104); n= 32 | -0.75 Mg of urine albumin/ mmol of creatinine | Standard Deviation 4.508 |
| Retigabine IR | Change From Baseline in Urine Albumin Creatinine Ratio | Visit 9 (Week 121); n= 30 | -0.89 Mg of urine albumin/ mmol of creatinine | Standard Deviation 5.421 |
| Retigabine IR | Change From Baseline in Urine Albumin Creatinine Ratio | Visit 10 (Week 138); n= 26 | -1.05 Mg of urine albumin/ mmol of creatinine | Standard Deviation 4.236 |
| Retigabine IR | Change From Baseline in Urine Albumin Creatinine Ratio | Visit 11 (Week 156); n= 22 | -0.65 Mg of urine albumin/ mmol of creatinine | Standard Deviation 2.494 |
| Retigabine IR | Change From Baseline in Urine Albumin Creatinine Ratio | Visit 12 (Week 173); n= 19 | -1.81 Mg of urine albumin/ mmol of creatinine | Standard Deviation 5.06 |
| Retigabine IR | Change From Baseline in Urine Albumin Creatinine Ratio | Visit 14 (Week 208); n= 8 | -1.70 Mg of urine albumin/ mmol of creatinine | Standard Deviation 4.032 |
| Retigabine IR | Change From Baseline in Urine Albumin Creatinine Ratio | Visit 15 (Week 225); n= 4 | 0.13 Mg of urine albumin/ mmol of creatinine | Standard Deviation 0.981 |
| Retigabine IR | Change From Baseline in Urine Albumin Creatinine Ratio | Visit 16 (Week 242); n= 3 | -0.33 Mg of urine albumin/ mmol of creatinine | Standard Deviation 0.153 |
| Retigabine IR | Change From Baseline in Urine Albumin Creatinine Ratio | Visit 17 (Week 260); n= 3 | -0.33 Mg of urine albumin/ mmol of creatinine | Standard Deviation 0.321 |
| Retigabine IR | Change From Baseline in Urine Albumin Creatinine Ratio | Visit 18 (Week 277); n= 2 | -0.50 Mg of urine albumin/ mmol of creatinine | Standard Deviation 0.99 |
| Retigabine IR | Change From Baseline in Urine Albumin Creatinine Ratio | Withdrawal visit; n= 63 | -0.35 Mg of urine albumin/ mmol of creatinine | Standard Deviation 3.874 |
| Retigabine IR | Change From Baseline in Urine Albumin Creatinine Ratio | Follow up visit; n= 48 | -0.62 Mg of urine albumin/ mmol of creatinine | Standard Deviation 3.515 |
Primary
Change From Baseline in Urine Albumin Levels
Urine samples were collected from participants for evaluation of change from Baseline in urinalysis parameters including albumin levels. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline and up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine IR | Change From Baseline in Urine Albumin Levels | Visit 1 (Screening); n= 39 | -5.2 Milligrams per liter (mg/L) | Standard Deviation 57.64 |
| Retigabine IR | Change From Baseline in Urine Albumin Levels | Visit 2 (Week 13); n= 72 | -1.8 Milligrams per liter (mg/L) | Standard Deviation 48.39 |
| Retigabine IR | Change From Baseline in Urine Albumin Levels | Visit 3 (Week 26); n= 54 | -17.1 Milligrams per liter (mg/L) | Standard Deviation 92.34 |
| Retigabine IR | Change From Baseline in Urine Albumin Levels | Visit 4 (Week 39); n= 53 | -21.0 Milligrams per liter (mg/L) | Standard Deviation 94.25 |
| Retigabine IR | Change From Baseline in Urine Albumin Levels | Visit 5 (Week 52); n= 52 | -21.6 Milligrams per liter (mg/L) | Standard Deviation 94.87 |
| Retigabine IR | Change From Baseline in Urine Albumin Levels | Visit 6 (Week 69); n= 46 | -15.7 Milligrams per liter (mg/L) | Standard Deviation 56.98 |
| Retigabine IR | Change From Baseline in Urine Albumin Levels | Visit 7 (Week 86); n= 47 | 7.7 Milligrams per liter (mg/L) | Standard Deviation 131.03 |
| Retigabine IR | Change From Baseline in Urine Albumin Levels | Visit 8 (Week 104); n= 32 | -8.1 Milligrams per liter (mg/L) | Standard Deviation 59.5 |
| Retigabine IR | Change From Baseline in Urine Albumin Levels | Visit 9 (Week 121); n= 30 | -14.7 Milligrams per liter (mg/L) | Standard Deviation 61.73 |
| Retigabine IR | Change From Baseline in Urine Albumin Levels | Visit 10 (Week 138); n= 26 | -16.0 Milligrams per liter (mg/L) | Standard Deviation 66.79 |
| Retigabine IR | Change From Baseline in Urine Albumin Levels | Visit 11 (Week 156); n= 22 | -7.4 Milligrams per liter (mg/L) | Standard Deviation 35.4 |
| Retigabine IR | Change From Baseline in Urine Albumin Levels | Visit 12 (Week 173); n= 19 | -27.2 Milligrams per liter (mg/L) | Standard Deviation 80.24 |
| Retigabine IR | Change From Baseline in Urine Albumin Levels | Visit 13 (Week 190); n= 10 | -2.8 Milligrams per liter (mg/L) | Standard Deviation 27.95 |
| Retigabine IR | Change From Baseline in Urine Albumin Levels | Visit 14 (Week 208); n= 8 | -15.9 Milligrams per liter (mg/L) | Standard Deviation 45.76 |
| Retigabine IR | Change From Baseline in Urine Albumin Levels | Visit 15 (Week 225); n= 4 | -1.8 Milligrams per liter (mg/L) | Standard Deviation 11.53 |
| Retigabine IR | Change From Baseline in Urine Albumin Levels | Visit 16 (Week 242); n= 3 | -8.7 Milligrams per liter (mg/L) | Standard Deviation 9.61 |
| Retigabine IR | Change From Baseline in Urine Albumin Levels | Visit 17 (Week 260); n= 3 | -3.3 Milligrams per liter (mg/L) | Standard Deviation 12.86 |
| Retigabine IR | Change From Baseline in Urine Albumin Levels | Visit 18 (Week 277); n= 2 | -7.5 Milligrams per liter (mg/L) | Standard Deviation 0.71 |
| Retigabine IR | Change From Baseline in Urine Albumin Levels | Withdrawal visit; n= 63 | -6.5 Milligrams per liter (mg/L) | Standard Deviation 51.69 |
| Retigabine IR | Change From Baseline in Urine Albumin Levels | Follow up visit; n= 48 | -19.9 Milligrams per liter (mg/L) | Standard Deviation 99.24 |
Primary
Change From Baseline in Urine Creatinine Levels
Urine samples were collected from participants for evaluation of change from Baseline in urinalysis parameters including creatinine levels. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline and up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine IR | Change From Baseline in Urine Creatinine Levels | Visit 1 (Screening); n= 52 | -2019.6 µmol/L | Standard Deviation 10153.7 |
| Retigabine IR | Change From Baseline in Urine Creatinine Levels | Visit 2 (Week 13); n= 89 | -1846.2 µmol/L | Standard Deviation 8206.65 |
| Retigabine IR | Change From Baseline in Urine Creatinine Levels | Visit 3 (Week 26); n= 75 | -3023.7 µmol/L | Standard Deviation 9197.5 |
| Retigabine IR | Change From Baseline in Urine Creatinine Levels | Visit 4 (Week 39); n= 66 | -2849.6 µmol/L | Standard Deviation 7810.79 |
| Retigabine IR | Change From Baseline in Urine Creatinine Levels | Visit 5 (Week 52); n= 63 | -1626.5 µmol/L | Standard Deviation 10205.13 |
| Retigabine IR | Change From Baseline in Urine Creatinine Levels | Visit 6 (Week 69); n= 59 | -3534.2 µmol/L | Standard Deviation 8657.09 |
| Retigabine IR | Change From Baseline in Urine Creatinine Levels | Visit 7 (Week 86); n= 55 | -2664.4 µmol/L | Standard Deviation 7900.3 |
| Retigabine IR | Change From Baseline in Urine Creatinine Levels | Visit 8 (Week 104); n= 42 | -2645.1 µmol/L | Standard Deviation 8368.43 |
| Retigabine IR | Change From Baseline in Urine Creatinine Levels | Visit 9 (Week 121); n= 37 | -1727.3 µmol/L | Standard Deviation 10330.75 |
| Retigabine IR | Change From Baseline in Urine Creatinine Levels | Visit 10 (Week 138); n= 35 | -1712.6 µmol/L | Standard Deviation 11352.03 |
| Retigabine IR | Change From Baseline in Urine Creatinine Levels | Visit 11 (Week 156); n= 30 | -1400.0 µmol/L | Standard Deviation 13151.92 |
| Retigabine IR | Change From Baseline in Urine Creatinine Levels | Visit 12 (Week 173); n= 23 | -1008.3 µmol/L | Standard Deviation 9395.56 |
| Retigabine IR | Change From Baseline in Urine Creatinine Levels | Visit 13 (Week 190); n= 19 | -3604.1 µmol/L | Standard Deviation 10215.2 |
| Retigabine IR | Change From Baseline in Urine Creatinine Levels | Visit 14 (Week 208); n= 10 | 3238.3 µmol/L | Standard Deviation 12290.24 |
| Retigabine IR | Change From Baseline in Urine Creatinine Levels | Visit 15 (Week 225); n= 5 | -675.0 µmol/L | Standard Deviation 16785.9 |
| Retigabine IR | Change From Baseline in Urine Creatinine Levels | Visit 16 (Week 242); n= 4 | -5426.3 µmol/L | Standard Deviation 13280.49 |
| Retigabine IR | Change From Baseline in Urine Creatinine Levels | Visit 17 (Week 260); n= 4 | 148.8 µmol/L | Standard Deviation 15164.36 |
| Retigabine IR | Change From Baseline in Urine Creatinine Levels | Visit 18 (Week 277); n= 2 | -7337.5 µmol/L | Standard Deviation 10850.55 |
| Retigabine IR | Change From Baseline in Urine Creatinine Levels | Withdrawal visit; n= 80 | -3570.3 µmol/L | Standard Deviation 8244.65 |
| Retigabine IR | Change From Baseline in Urine Creatinine Levels | Follow up visit; n= 60 | -515.8 µmol/L | Standard Deviation 9359.74 |
Primary
Changes From Baseline in American Urological Association Symptom Scale (AUA SS) Score
The effect of retigabine on bladder function was assessed using AUA symptom index. It is a 7-item Likert-scored scale ranging from 0 (no symptom at all) to 5 (almost always symptoms present) with a total possible score of 35. AUA SS score is the sum of the responses to these seven questions. The total score for all questions was classified as mild (0 to 7), moderate (8 to 19), or severe (\>19). Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline and up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine IR | Changes From Baseline in American Urological Association Symptom Scale (AUA SS) Score | Visit 8 (Week 104); n= 42 | -1.0 Score on AUA SS scale | Standard Deviation 3.79 |
| Retigabine IR | Changes From Baseline in American Urological Association Symptom Scale (AUA SS) Score | Visit 11 (Week 156); n= 31 | -1.0 Score on AUA SS scale | Standard Deviation 4.18 |
| Retigabine IR | Changes From Baseline in American Urological Association Symptom Scale (AUA SS) Score | Visit 14 (Week 208); n= 10 | -2.3 Score on AUA SS scale | Standard Deviation 5.54 |
| Retigabine IR | Changes From Baseline in American Urological Association Symptom Scale (AUA SS) Score | Visit 17 (Week 260); n= 4 | -6.5 Score on AUA SS scale | Standard Deviation 7.72 |
| Retigabine IR | Changes From Baseline in American Urological Association Symptom Scale (AUA SS) Score | Withdrawal visit; n= 85 | -1.0 Score on AUA SS scale | Standard Deviation 3.99 |
| Retigabine IR | Changes From Baseline in American Urological Association Symptom Scale (AUA SS) Score | Visit 3 (Week 26); n= 82 | -0.7 Score on AUA SS scale | Standard Deviation 3.5 |
| Retigabine IR | Changes From Baseline in American Urological Association Symptom Scale (AUA SS) Score | Visit 5 (Week 52); n= 68 | -0.9 Score on AUA SS scale | Standard Deviation 4.67 |
Primary
Duration of Retigabine Exposure
Duration of exposure was calculated from the first dose through the last dose during study including the Taper Phase and presented using median and full range.
Time frame: Up to 5.8 years
Population: Safety Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Retigabine IR | Duration of Retigabine Exposure | 103.7 Weeks |
Primary
Number of Participants Experiencing New Seizure Types
Number of participants experiencing new seizure type that is seizure not experienced before were summarized. New seizure types were classified into 5 classes including type A (simple partial seizure), type B (complex partial seizure), type C (Partials, evolving to Secondary Generalized Seizures), type D (Generalized, excluding Myoclonic Seizures), type D2 (Myoclonic Seizures) and type E (Unclassified Seizures).
Time frame: Up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retigabine IR | Number of Participants Experiencing New Seizure Types | Type A; Simple Partial Seizures | 5 Participants |
| Retigabine IR | Number of Participants Experiencing New Seizure Types | Type B; Complex Partial Seizures | 2 Participants |
| Retigabine IR | Number of Participants Experiencing New Seizure Types | Type C; Partials, evolving to Sec. Gen. Seizures | 0 Participants |
| Retigabine IR | Number of Participants Experiencing New Seizure Types | Type D; Generalized, excl. Myoclonic Seizures | 0 Participants |
| Retigabine IR | Number of Participants Experiencing New Seizure Types | Type D2; Myoclonic Seizures | 0 Participants |
| Retigabine IR | Number of Participants Experiencing New Seizure Types | Type E; Unclassified seizures | 0 Participants |
Primary
Number of Participants Experiencing Worsening of Seizures
Worsening of seizures was defined as an increase in seizure frequency or the occurrence of a new, more severe seizure type, or status epilepticus occurring in a participant without a history of status epilepticus. An increase in seizure frequency was defined as doubling of the 28-day seizure frequency compared to the 28-day Baseline seizure frequency established in the parent study. Number of participants experiencing worsening of seizure during study period are presented.
Time frame: Up to 5.8 years
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Retigabine IR | Number of Participants Experiencing Worsening of Seizures | 1 Participants |
Primary
Number of Participants With Abnormal Discoloration of Skin
Number of participants with Dermatologist-Confirmed abnormal discoloration of skin including skin around the eyes and eyelids, lips, nails, or mucosa were evaluated. Only abnormalities occurring on-treatment with retigabine were presented.
Time frame: Up to 5.8 years
Population: Safety Population. Only those participants who had at least one skin exam by the investigator or dermatologist on or before the last dose of RTG or dermatologist-confirmed discoloration with start date on or before the date of last dose of RTG are presented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retigabine IR | Number of Participants With Abnormal Discoloration of Skin | Discoloration of nails | 10 Participants |
| Retigabine IR | Number of Participants With Abnormal Discoloration of Skin | Discoloration of mucosa | 9 Participants |
| Retigabine IR | Number of Participants With Abnormal Discoloration of Skin | Any abnormal discoloration | 11 Participants |
| Retigabine IR | Number of Participants With Abnormal Discoloration of Skin | Discoloration of skin | 5 Participants |
| Retigabine IR | Number of Participants With Abnormal Discoloration of Skin | Discoloration of lips | 3 Participants |
Primary
Number of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination
Number of participants with a clinically significant decrease in visual acuity from initial examination were evaluated. Only abnormalities occurring on-treatment with retigabine were presented.
Time frame: Up to 5.8 years
Population: Safety Population. Only those participants with both initial and at least 1 follow-up exam while on RTG treatment are presented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Retigabine IR | Number of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination | 3 Participants |
Primary
Number of Participants With AEs and SAEs: All SFUCP Subjects
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect or is associated with liver injury or impaired liver function. The following AEs were collected in the SFUCP: AEs related to the finding(s) of pigmentation/, discoloration of the eye/skin, AEs related to unexplained vision loss, SAEs, Deaths and Pregnancies. SFUCP collected AEs are those for which onset was 31 days or more after the last dose of retigabine. The analysis was performed on the All SFUCP Subjects population which comprised of all subjects who enter the SFUCP.
Time frame: Up to 2.6 years
Population: All SFUCP subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retigabine IR | Number of Participants With AEs and SAEs: All SFUCP Subjects | Any AE | 3 Participants |
| Retigabine IR | Number of Participants With AEs and SAEs: All SFUCP Subjects | Any SAE | 1 Participants |
Primary
Number of Participants With Clinical Chemistry Parameters of PCC
Number of participants with chemistry parameters of PCC at 'any visit post-Baseline' are presented. Chemistry parameters for which PCC values were identified were alanine aminotransferase (ALT) (if value \>=3 \* upper limit of normal \[ULN\]), alkaline phosphatase (alk.phosphatase) (if value \>=3\*ULN), aspartate aminotransferase (AST) (if value \>=3\*ULN), calcium (if value \<=1.8962 or \>=2.8692), carbon-di-oxide (CO2) (if value \<=18 or \>=36), chloride (if value \<=92 or \>=112), creatine kinase (if value \>=3\*ULN), direct bilirubin (if value \>=1.5\*ULN), glucose (if value \<=2.7755 or \>=11.102), lactate dehydrogenase (LD) (if value \>=3\*ULN), magnesium (if value \<0.36 or \>2.50), potassium (if value \<=3.0 or \>=6.0), sodium (if value \<=127 or \>=153), total bilirubin (if value \>=1.5\*ULN), total protein (if value \<45 or \>100), blood urea nitrogen (BUN) (if value \>=14.28). Only those participants with data available at specific time points were analyzed (represented by n=X in the category titles).
Time frame: Up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | ALT; high; n= 98 | 2 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | Alk.phosphatase; high; n= 98 | 0 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | AST; high; n= 98 | 1 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | Calcium; high; n= 98 | 0 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | Calcium; low; n= 98 | 0 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | CO2 content/bicarbonate; high; n= 98 | 0 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | CO2 content/bicrbonate; low; n= 98 | 10 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | Chloride; high; n= 98 | 6 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | Chloride; low; n= 98 | 2 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | Creatine kinase; high; n= 98 | 6 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | Creatinine; high; n= 98 | 0 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | Direct bilirubin; high; n= 98 | 0 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | Glucose; high; n= 98 | 3 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | Glucose; low; n= 98 | 1 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | LD ; high; n= 98 | 1 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | Magnesium; high; n= 98 | 0 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | Magnesium; low; n= 98 | 0 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | Potassium; high; n= 98 | 1 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | Potassium; low; n= 98 | 0 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | Sodium; high; n= 91 | 0 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | Sodium; low; n= 91 | 2 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | Total bilirubin; high; n= 98 | 1 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | Total protein; high; n= 98 | 0 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | Total protein; low; n= 98 | 0 Participants |
| Retigabine IR | Number of Participants With Clinical Chemistry Parameters of PCC | BUN; high; n= 91 | 0 Participants |
Primary
Number of Participants With Decrease in Confrontational Visual Field From Initial Examination
Number of participants with a clinically significant decrease in confrontational visual field from initial examination were evaluated. Only abnormalities occurring on-treatment with retigabine were presented.
Time frame: Up to 5.8 years
Population: Safety Population. Only those subjects with both initial and at least 1 follow-up exam while on RTG treatment are presented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Retigabine IR | Number of Participants With Decrease in Confrontational Visual Field From Initial Examination | 1 Participants |
Primary
Number of Participants Withdrawn Due to TEAEs
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolonged existing hospitalization, results in disability, is a congenital anomaly/birth defect or is associated with liver injury or impaired liver function. TEAE refers to an AE for which the onset was on or after the date of the first retigabine dose and on or before 30 days after the last retigabine dose date.
Time frame: Up to 5.8 years
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Retigabine IR | Number of Participants Withdrawn Due to TEAEs | 16 Participants |
Primary
Number of Participants With Hematology Parameters of PCC
Blood samples were collected from participants to evaluate hematology parameters. Number of participants with clinical hematology parameters of PCC at 'any visit post-Baseline' are presented. Hematology parameters for which PCC values were identified were eosinophils (if value is \>0.8), hematocrit (if value is \<=0.32 for males and \<=0.28 for females), platelet count (if value is \<=100 or \>=550), total neutrophils (if value is \<=1.8), white blood cells (WBC) (if value is \<=2.8 or \>=16). Only those participants with data available at specific time points were analyzed (represented by n=X in the category titles).
Time frame: Up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retigabine IR | Number of Participants With Hematology Parameters of PCC | Hemoglobin; low; n= 98 | 3 Participants |
| Retigabine IR | Number of Participants With Hematology Parameters of PCC | Eosinophils; high; n= 98 | 7 Participants |
| Retigabine IR | Number of Participants With Hematology Parameters of PCC | Hematocrit; low; n= 98 | 4 Participants |
| Retigabine IR | Number of Participants With Hematology Parameters of PCC | Platelet count; high; n= 98 | 1 Participants |
| Retigabine IR | Number of Participants With Hematology Parameters of PCC | Platelet count; low; n= 98 | 4 Participants |
| Retigabine IR | Number of Participants With Hematology Parameters of PCC | Total neutrophils; low; n= 98 | 20 Participants |
| Retigabine IR | Number of Participants With Hematology Parameters of PCC | WBC; high; n= 91 | 2 Participants |
| Retigabine IR | Number of Participants With Hematology Parameters of PCC | WBC; low; n= 91 | 3 Participants |
Primary
Number of Participants With Pigmentation of Non-retinal Ocular Tissue(s)
Number of participants with abnormal findings after eye examination were evaluated. Pigmentation of non-retinal ocular tissue (s) detected on-treatment with retigabine were presented. Non-retinal pigmentary abnormalities included abnormalities in the sclera and/ or conjunctiva, cornea, iris and lens.
Time frame: Up to 5.8 years
Population: Safety Population. Only those participants with \>=1 ophthalmology exam on or before last dose of RTG are presented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Retigabine IR | Number of Participants With Pigmentation of Non-retinal Ocular Tissue(s) | 15 Participants |
Primary
Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline in Vital Signs and Weight
Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were measured after at least 5 minutes of rest. Body weight was measured without shoes and wearing light clothing. Baseline assessments in this OLE study were defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Increase or decrease of \>=20 in SBP, increase or decrease of \>=15 in DBP and HR were considered as PCC values. Number of participants with PCC values of vital signs for any visit post-Baseline are presented.
Time frame: Up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retigabine IR | Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline in Vital Signs and Weight | HR; decrease of >=15 | 15 Participants |
| Retigabine IR | Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline in Vital Signs and Weight | Weight; decrease of >=7 percent | 10 Participants |
| Retigabine IR | Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline in Vital Signs and Weight | Weight; increase of >=7 percent | 32 Participants |
| Retigabine IR | Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline in Vital Signs and Weight | DBP; decrease of >=15 | 15 Participants |
| Retigabine IR | Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline in Vital Signs and Weight | DBP; increase of >=15 | 7 Participants |
| Retigabine IR | Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline in Vital Signs and Weight | HR; increase of >=15 | 18 Participants |
| Retigabine IR | Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline in Vital Signs and Weight | SBP; decrease of >=20 | 18 Participants |
| Retigabine IR | Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline in Vital Signs and Weight | SBP; increase of >=20 | 8 Participants |
Primary
Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine
The ophthalmologist/retina specialist determined the presence or absence of retinal and non-retinal ocular abnormalities. Retinal abnormalities included abnormalities in the macula and/or the peripheral retina and non-retinal ocular pigmentary abnormality.
Time frame: Up to 2.6 years
Population: All SFUCP Subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retigabine IR | Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine | Retinal pigmentary abnormality | 1 Participants |
| Retigabine IR | Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine | Non-retinal ocular pigmentary abnormality | 1 Participants |
Primary
Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration After Discontinuation of Retigabine
Participants who enter the SFUCP who had an on-treatment finding(s) of abnormal discoloration of skin, lips, nails or mucosa confirmed by a dermatologist entered the SFUCP and underwent assessments performed by a dermatologist at 6-monthly intervals. The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa.
Time frame: Up to 2.6 years
Population: All SFUCP Subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Retigabine IR | Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration After Discontinuation of Retigabine | 2 Participants |
Primary
Number of Participants With Retinal Pigmentary Abnormalities
Number of participants with abnormal findings after eye examination were evaluated. Only retinal pigmentary abnormalities detected on-treatment with retigabine were presented. Retinal pigmentary abnormalities included abnormalities in the macula, peripheral retina and unspecified location.
Time frame: Up to 5.8 years
Population: Safety Population. Only those participants with \>=1 ophthalmology exam on or before last dose of RTG are presented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Retigabine IR | Number of Participants With Retinal Pigmentary Abnormalities | 8 Participants |
Primary
Number of Participants With Suicidal Ideation or Behavior Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score
Number of participants with suicidal ideation or behavior during treatment were assessed using the C-SSRS score scale. It is a brief questionnaire designed to assess severity and change in suicidality by integrating both behavior and ideation using a semi-structured interview to probe participant responses. Participants are classified with respect to extent of suicidal ideation, extent of suicidal behavior, and with respect to self-injurious behavior.
Time frame: Up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retigabine IR | Number of Participants With Suicidal Ideation or Behavior Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score | Suicidal ideation | 1 Participants |
| Retigabine IR | Number of Participants With Suicidal Ideation or Behavior Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score | Suicidal behavior | 0 Participants |
| Retigabine IR | Number of Participants With Suicidal Ideation or Behavior Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score | Self-injurious behavior, no suicidal attempt | 0 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (TESAEs): Safety Population
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect or is associated with liver injury or impaired liver function. TEAE refers to an AE for which the onset was on or after the date of the first retigabine dose in this study and on or before 30 days after the last retigabine dose date. AEs that started in the parent study that increased in severity during this study were also considered treatment-emergent. The analysis was performed on Safety Population, which included participants who took at least one dose of study medication after they had enrolled into this OLE study.
Time frame: Up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retigabine IR | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (TESAEs): Safety Population | Any TESAE | 4 Participants |
| Retigabine IR | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (TESAEs): Safety Population | Any TEAE | 38 Participants |
Primary
Number of Participants With Urinalysis Parameters of PCC
Urine samples were collected from participants at specific time points. Number of participants with urinalysis parameters of PCC at 'any visit post-Baseline' are presented. Urinalysis parameters for which PCC values were identified were albumin/creatinine ratio (if value is \>11.3), red blood cells (RBC) (if value is 3-5 or higher), WBC (if value is 5-10 or higher for male and 10-15 or higher for females), specific gravity (if value is \<1.001 or \>1.035) and potential of hydrogen (pH) (if value is \<4.6 or \>8.0). Only those participants with data available at specific time points were analyzed (represented by n=X in the category titles).
Time frame: Up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retigabine IR | Number of Participants With Urinalysis Parameters of PCC | Albumin/creatinine ratio; high; n= 96 | 4 Participants |
| Retigabine IR | Number of Participants With Urinalysis Parameters of PCC | RBC; high; n= 98 | 54 Participants |
| Retigabine IR | Number of Participants With Urinalysis Parameters of PCC | WBC; high; n= 91 | 59 Participants |
| Retigabine IR | Number of Participants With Urinalysis Parameters of PCC | Specific gravity; high; n= 91 | 4 Participants |
| Retigabine IR | Number of Participants With Urinalysis Parameters of PCC | Specific gravity; low; n= 91 | 0 Participants |
| Retigabine IR | Number of Participants With Urinalysis Parameters of PCC | pH; high; n= 98 | 1 Participants |
| Retigabine IR | Number of Participants With Urinalysis Parameters of PCC | pH; low; n= 98 | 0 Participants |
Primary
Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation
Retinal pigmentary abnormality was determined by either an ophthalmologist or retina specialist. Retinal pigmentary abnormality included abnormality of macula, peripheral retina and unspecified location. If a participant had pigmentary abnormality of macula and pigmentary abnormality of the peripheral retina both should be resolved in order for retinal pigmentary abnormality to be considered resolved. If a participant had non-retinal ocular pigmentary abnormality in more than one location (conjunctiva, sclera, cornea, iris or lens), all should be resolved for non-retinal pigmentary abnormality to be considered resolved.
Time frame: Up to 2.6 years
Population: All SFUCP Subjects
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Retigabine IR | Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation | Retinal Pigmentary Abnormality | 157.0 Days |
| Retigabine IR | Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation | Non-Retinal Ocular Pigmentary Abnormality | 119.0 Days |
Primary
Time From Discontinuation of Retigabine to Resolution of All Dermatologist-confirmed Abnormal Discoloration
Assessments were at approximately 6-monthly intervals (timed relative to the participants previous dermatology assessment) until the abnormal discoloration either resolved or stabilized (as defined by no changes over 2 consecutive 6-monthly assessments performed by the dermatologist over at least 12 months after discontinuation of retigabine). The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa. Only participants with resolution of the specified tissue are included in this analysis.
Time frame: Up to 2.6 years
Population: All SFUCP Subjects
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Retigabine IR | Time From Discontinuation of Retigabine to Resolution of All Dermatologist-confirmed Abnormal Discoloration | All; n= 2 | 582.0 Days |
| Retigabine IR | Time From Discontinuation of Retigabine to Resolution of All Dermatologist-confirmed Abnormal Discoloration | Skin; n= 1 | 192.0 Days |
| Retigabine IR | Time From Discontinuation of Retigabine to Resolution of All Dermatologist-confirmed Abnormal Discoloration | Nails; n= 1 | 253.0 Days |
| Retigabine IR | Time From Discontinuation of Retigabine to Resolution of All Dermatologist-confirmed Abnormal Discoloration | Mucosa; n= 3 | 701.0 Days |
Secondary
Number of Participants Experiencing a 0 to <25, 25 to <50, 50 to <75 and 75 to 100 Percent Reduction in 28 Day POS Frequency From Baseline
The seizure frequency was recorded in daily seizure calendar by participants during the treatment period. Baseline assessments in this OLE study are defined by and taken directly from the Baseline assessments in the parent study NCT01336621.
Time frame: Baseline and up to 5.8 years
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retigabine IR | Number of Participants Experiencing a 0 to <25, 25 to <50, 50 to <75 and 75 to 100 Percent Reduction in 28 Day POS Frequency From Baseline | 0 to <25 percent reduction | 7 Participants |
| Retigabine IR | Number of Participants Experiencing a 0 to <25, 25 to <50, 50 to <75 and 75 to 100 Percent Reduction in 28 Day POS Frequency From Baseline | 25 to <50 percent reduction | 13 Participants |
| Retigabine IR | Number of Participants Experiencing a 0 to <25, 25 to <50, 50 to <75 and 75 to 100 Percent Reduction in 28 Day POS Frequency From Baseline | 75 to 100 percent reduction | 42 Participants |
| Retigabine IR | Number of Participants Experiencing a 0 to <25, 25 to <50, 50 to <75 and 75 to 100 Percent Reduction in 28 Day POS Frequency From Baseline | 50 to <75 percent reduction | 26 Participants |
Secondary
Number of Participants Experiencing an Increase in 28-day Partial-onset Seizure Frequency From Baseline
The seizure frequency was recorded in daily seizure calendar by participants during the treatment period. Baseline assessments in this OLE study are defined by and taken directly from the Baseline assessments in the parent study NCT01336621.
Time frame: Baseline and up to 5.8 years
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Retigabine IR | Number of Participants Experiencing an Increase in 28-day Partial-onset Seizure Frequency From Baseline | 10 Participants |
Secondary
Number of Participants Who Remained Seizure-free
The seizure frequency was recorded in daily seizure calendar by participants during the treatment period. Number of participants who were treated retigabine for at least 6 months and who remained seizure free for any 6 continuous months as well as number of participants who were treated with retigabine for at least 12 months and who remained seizure free for any 12 continuous months are presented.
Time frame: Up to 5.8 years
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retigabine IR | Number of Participants Who Remained Seizure-free | Seizure free for 6 months; n= 85 | 27 Participants |
| Retigabine IR | Number of Participants Who Remained Seizure-free | Seizure free for 12 months; n= 71 | 13 Participants |
Secondary
Percent Change From Baseline in 28-day Partial-onset Seizure Frequency
The seizure frequency was recorded in daily seizure calendar by participants during the treatment period. Percent change from Baseline in 28-day partial onset seizure frequency was presented as mean and standard deviation (SD). Baseline assessments in this OLE study are defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Percent change from Baseline was calculated as post-Baseline value minus Baseline value divided by Baseline value into 100.
Time frame: Baseline and up to 5.8 years
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Retigabine IR | Percent Change From Baseline in 28-day Partial-onset Seizure Frequency | -56.9 Percent change | Standard Deviation 52.46 |