Epilepsy
Conditions
Brief summary
This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of ezogabine/retigabine in subjects aged 12 years to less than 18 years with uncontrolled partial onset seizures or Lennos-Gastaut syndrome.
Interventions
ezogabine dose escalation
Sponsors
Bausch Health Americas, Inc.
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Between 12 and 18 years of age. * Diagnosis of uncontrolled partial onset seizures (with or without secondarily generalized seizures) or Lennox-Gastaut syndrome. * Taking between one and three antiepileptic drugs. * Able to swallow tablets. * Females must be of : (1) Non-childbearing potential or (2) Child-bearing potential and agrees to use acceptable contraception.
Exclusion criteria
* Epilepsy secondary to progressive cerebral disease, tumor or any progressive neurodegenerative disease. * History of status epilepticus in the last six months. * Currently treated with felbamate or has been treated with vigabatrin within the past 6 months. * Following the ketogenic diet. * Suicidal intent or history of suicide attempt in the last 2 years. * Elevated liver enzymes or abnormal kidney function. * Current disturbance of micturition or known urinary obstructions. * History of vesicoureteric reflux. * Abnormal post-void residual bladder ultrasound. * Urinary retention and/or required urinary catheterization in the preceding 6 months. * Abnormal urine sample at screening/.baseline. * Abnormal blood sample at screening. * Clinically significant arrhythmias. * Abnormal ECG at screening. * BMI lower than the 10th percentile for age and gender or subject weighs less than 30kg.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) Following Oral Administration of Ezogabine/Retigabine | Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 | The steady state pharmacokinetic profile following oral administration of ezogabine/retigabine included determining the area under the curve over the dosing interval (AUC\[0-tau\]). The area under the plasma concentration-time curve over the dosing interval (AUC\[0-tau\]) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate AUC(0-tau). |
| Apparent Clearance (CL/F) Following Oral Administration of Ezogabine/Retigabine | Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 | Clearance (CL/F) is defined as dose/AUC(0-tau). Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate CL/F. |
| Maximum Observed Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) Following Oral Administration of Ezogabine/Retigabine | Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 | Cmax is defined as the first occurrence of the maximum observed plasma concentration. Ctau refers to the pre-dose (trough) concentration after the dosing interval which is equal to the minimum observed concentration (Cmin) at Steady State. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate Cmax and Ctau. |
| Apparent Volume of Distribution (Vd/F) Following Oral Administration of Ezogabine/Retigabine | Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 | The volume of distribution (Vd/F) is defined as MRT\*CL/F, where MRT is the mean residence time (calculated as AUMC\[0-tau\]/AUC\[0-tau\], where AUMC\[0-tau\] is the area under the first moment curve determined as the area under the concentration\*time versus time curve). Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate the apparent volume of distribution. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Baseline (Screening), Day 7, Day 21, and Day 35 | Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit. |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration | Baseline (Screening), Day 7, Day 21, and Day 35 | Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit. |
| Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration at Day 7 Post Each Up-titration | Baseline (Screening), Day 7, Day 21, and Day 35 | Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit. |
| Change From Baseline in Hematocrit at Day 7 Post Each Up-titration | Baseline (Screening), Day 7, Day 21, and Day 35 | Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit. The International System of Units (SI) Fraction of one unit (1) is reported here. |
| Change From Baseline in Mean Corpuscle Hemoglobin at Day 7 Post Each Up-titration | Baseline (Screening), Day 7, Day 21, and Day 35 | Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit. |
| Change From Baseline in Mean Corpuscle Volume at Day 7 Post Each Up-titration | Baseline (Screening), Day 7, Day 21, and Day 35 | Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit. |
| Change From Baseline in Red Blood Cell Count at Day 7 Post Each Up-titration | Baseline (Screening), Day 7, Day 21, and Day 35 | Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit. |
| Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | Screening, Day 1 (D1), Day 7 (D7), Day 14 (D14), Day 21 (D21), Day 28 (D28), Day 35 (D35), and at the Follow-up Visit (up to Day 46) | Urinalysis parameters analyzed included: urine occult blood (UOB), urine glucose (UG), urine ketones (UK), and urine protein (UP). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test provides results in a semi-quantitative manner, and results can be read as negative (Neg), Trace, and 80, indicating proportional concentrations in the urine sample. Urinalysis parameters were assessed at Titration 1 (T1; 300 mg/day), Titration 2 (T2; 450 mg/day), Titration 3 (T3; 600 mg/day), Titration 4 (T4; 750 mg/day), and Titration 5 (T5; 900 mg/day). |
| Percent Change From Baseline in 28-day Seizure Frequency Rate | Baseline (Screening) and until Follow-up or early discontinuation (assessed up to 46 days) | Participants or their caregivers recorded the number of seizures experienced by the participant, by seizure type (e.g., simple partial seizure \[seizure that affects only a small region of the brain; consciousness is unaffected\], complex partial seizure \[seizure associated with unilateral cerebral hemisphere involvement and causing impairment of awareness or responsiveness\], etc.), as well as by duration of episodes of innumerable seizure activity, in their daily diaries during all phases of this study. Percent change from baseline is defined as 100 \* (rate in a given period minus the baseline rate) / (baseline rate). baseline seizures are defined as those seizures that occurred after Screening and before the start of the treatment. Post-baseline seizures are defined as those seizures that occurred from the start of the treatment until the start of Follow-up. Seizure frequency rate was computed as: 28 \* (number of seizures during given period / number of days in given period). |
| Number of Participants With Any Adverse Event (AE) | From the start of the first titration until follow-up (assessed up to 46 days) | An AE is defined as 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. |
| Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) for the N-acetyl Metabolite of Ezogabine/Retigabine | Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 | Ctau refers to the pre-dose (trough) concentration at the end of the dosing interval which is equivalent to the minimum observed concetration (Cmin) at Steady State. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess the Ctau for n-acetyl metabolite (NAMR) of ezogabine/retigabine following oral administration of ezogabine/retigabine. |
| Time to Maximum Concentration (Tmax) Following Oral Administration of Ezogabine/Retigabine | Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 | Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess plasma Tmax. |
| Plasma Half Life at Steady State (t1/2) Following Oral Administration of Ezogabine/Retigabine | Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 | Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess plasma t1/2. Steady-state t1/2 is derived as (Vd/F) / (CL/F), where Vd/F is defined as the apparent volume of distribution after extravascular (e.g., oral) administration, and CL/F is defined as the apparent clearance following oral dosing. |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Baseline (Screening) and Day 7 post up-titration, up to Day 35 | An ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected for heart rate (QTc intervals) was used. Measurements were taken 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 14 for up-titration to 450 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 28 for up-titration to 750 mg/day dose; Day 35 for up-titration to 900 mg/day dose). ECG parameters were assessed at Titration 1 (T1; 300 mg/day): Day 1 pre-dose, Day 1 at 3 hours (h), pre-dose, and 3 h post-dose. Titration 2 (T2; 450 mg/day): Day 7. Titration 3 (T3; 600 mg/day): pre-dose and 3 h post-dose. Titration 3 Dose Held (T3DH): pre-dose. Titration 4 (T4; 750 mg/day): Day 7. Titration 5 (T5; 900 mg/day): pre-dose and 3 h post-dose. The number of participants with abnormal (Abn) clinically significant (CS) and not clinically significant (NCS) ECG findings was recorded. The investigator determined if an ECG finding was CS or NCS. |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | Baseline (Screening) and Day 7 post up-titration, up to Day 35 | Vital sign assessment included the measurement of systolic and diastolic blood pressure at Titration 1 (T1; 300 mg/day): Day 1 pre-dose, Day 1 at 3 hours (h), Day 7 pre-dose, and 3 h post dose. Titration 2 (T2; 450 mg/day): Day 7. Titration 3 (T3; 600 mg/day): Day 21 pre-dose and 3 h post-dose. Titration 3 Dose Held (T3DH): pre-dose. Titration 4 (T4; 750 mg/day): Day 7. Titration 5 (T5; 900 mg/day): Day 35 pre-dose and 3 h post-dose. Measurements were taken 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 14 for up-titration to 450 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 28 for up-titration to 750 mg/day dose; Day 35 for up-titration to 900 mg/day dose). Change from baseline was calculated by subtracting the baseline value from the individual post-dose values. Baseline is defined as as the Day 1 pre-dose value. |
| Change From Baseline in Heart Rate (HR) | Baseline (Screening) and Day 7 post up-titration, up to Day 35 | Vital sign assessment included heart rate measurement and was assessed at Titration 1 (T1; 300 mg/day): Day 1 pre-dose, Day 1 at 3 hours (h), pre-dose and 3 h post-dose. Titration 2 (T2; 450 mg/day): Day 7. Titration 3 (T3; 600 mg/day): pre-dose and 3 h post-dose. Titration 3 Dose Held (T3DH): pre-dose. Titration 4 (T4; 750 mg/day): Day 7. Titration 5 (T5; 900 mg/day): pre-dose and 3 h post-dose. Measurements were taken 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 14 for up-titration to 450 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 28 for up-titration to 750 mg/day dose; Day 35 for up-titration to 900 mg/day dose). Change from baseline was calculated by subtracting the baseline value from the individual post-dose values. Baseline is defined as as the Day 1 pre-dose value. |
| Change From Baseline in Post Void Residual Ultrasound at Day 21 | Screening and Day 7 of Titration 3 (Day 21) | A post void residual (PVR) bladder ultrasound was carried out as a measure of bladder function. PVR was clinically indicated following the occurrence of adverse events relating to the lower urinary tract (e.g., micturition difficulties, including urinary hesitancy or urinary retention). These assessments were also repeated following drug withdrawal following such events. A prompt follow-up PVR was recommended if a high score was obtained from a participant on the Pediatric Lower Urinary Tract Symptom scale (the PLUTS scale is a clinician-rated scale used to assess lower urinary tract symptoms, including urinary retention) and if the clinician felt that the participant was at risk or had symptoms of urinary retention. PVR was measured at Day 7 of Titration 3 (600 mg/day). Baseline is defined as the Screening visit. |
| Number of Participants With the Indicated Neurological Abnormality | Screening and Day 7 of Titration 3 (Day 21) | Abnormal Central Nervous System (CNS) symptoms were assessed by a full and brief neurological examination. A full neurological examination included assessment of mental status, cranial nerves, gait, coordination, sensation, speech/language, muscle strength, muscle tone, and reflexes. A brief neurological examination included assessment of mental status, cranial nerves, gait, coordination, reflexes, and speech/language. Neurological parameters assessed were memory impairment, impaired intellect, decreased attention, psychomotor slowing, decreased muscle strength, hpertonia, somnolence, right and left bicpes, right and left brachioradialis, right and left knee, right and left ankle, and right and left planter response. Neurological examination was performed at Day 7 of Titration 3 (600 mg/day). |
| Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Last Time of Quantifiable Concentration (AUC [0-t]) for the N-acetyl Metabolite of Ezogabine/Retigabine | Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 | The area under the curve was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess the plasma n-acetyl metabolite (NAMR) of ezogabine/retigabine following oral administration of ezogabine/retigabine. |
| Change From Baseline in Albumin and Total Protein at Day 7 Post Each Up-titration | Baseline (Screening), Day 7, Day 21, and Day 35 | Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit. |
| Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Day 7 Post Each Up-titration | Baseline (Screening), Day 7, Day 21, and Day 35 | Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit. |
| Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Day 7 Post Each Up-titration | Baseline (Screening), Day 7, Day 21, and Day 35 | Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit. |
Countries
United States
Participant flow
Recruitment details
Enrolled participants (par.) were aged 12 years to less than 18 years with partial onset seizures or Lennox-Gastaut syndrome (LGS), and were required to be on at least 1 but not more than 3 anti-epileptic therapies without achieving complete control of their seizures.
Pre-assignment details
A total of 5 par. who met the eligibility criteria were assigned to Regimen A (\>50 kilograms \[kg\]) or B (30 to \<=50 kg) based on body weight and entered a 2-week Screening phase, followed by a dosing phase (up to 5 weeks). Upon completion of the dosing phase, par. either entered a follow-up phase or a separate extension study.
Participants by arm
| Arm | Count |
|---|---|
| Ezogabine/Retigabine Participants received an initial dose of ezogabine/retigabine 300 milligrams (mg) per day administered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at Weeks 1, 3, and 5. Dose titration occurred no more than once per week, with participants receiving up-titrated daily doses of 450 mg (150 mg TID), 600 mg (200 mg TID), 750 mg (250 mg TID), and 900 mg (300 mg TID) at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval. | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study Closed/Terminated | 1 |
Baseline characteristics
| Characteristic | Ezogabine/Retigabine |
|---|---|
| Age, Continuous | 14.6 Years STANDARD_DEVIATION 1.34 |
| Race/Ethnicity, Customized White-White/Caucasian/European Heritage | 5 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 5 | 1 / 5 | 1 / 4 | 0 / 4 | 0 / 3 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 4 | 0 / 4 | 0 / 3 |
Outcome results
Primary
Apparent Clearance (CL/F) Following Oral Administration of Ezogabine/Retigabine
Clearance (CL/F) is defined as dose/AUC(0-tau). Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate CL/F.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Apparent Clearance (CL/F) Following Oral Administration of Ezogabine/Retigabine | 178.6 Liters/Hour |
| Regimen A: E/R 300/450 mg Then 600 mg | Apparent Clearance (CL/F) Following Oral Administration of Ezogabine/Retigabine | 234.5 Liters/Hour |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Apparent Clearance (CL/F) Following Oral Administration of Ezogabine/Retigabine | 237.9 Liters/Hour |
Primary
Apparent Volume of Distribution (Vd/F) Following Oral Administration of Ezogabine/Retigabine
The volume of distribution (Vd/F) is defined as MRT\*CL/F, where MRT is the mean residence time (calculated as AUMC\[0-tau\]/AUC\[0-tau\], where AUMC\[0-tau\] is the area under the first moment curve determined as the area under the concentration\*time versus time curve). Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate the apparent volume of distribution.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35
Population: Pharmacokinetic Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Apparent Volume of Distribution (Vd/F) Following Oral Administration of Ezogabine/Retigabine | 1130.9 Liters |
| Regimen A: E/R 300/450 mg Then 600 mg | Apparent Volume of Distribution (Vd/F) Following Oral Administration of Ezogabine/Retigabine | 2118.0 Liters |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Apparent Volume of Distribution (Vd/F) Following Oral Administration of Ezogabine/Retigabine | 1934.3 Liters |
Primary
Maximum Observed Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) Following Oral Administration of Ezogabine/Retigabine
Cmax is defined as the first occurrence of the maximum observed plasma concentration. Ctau refers to the pre-dose (trough) concentration after the dosing interval which is equal to the minimum observed concentration (Cmin) at Steady State. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate Cmax and Ctau.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35
Population: Pharmacokinetic Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Maximum Observed Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) Following Oral Administration of Ezogabine/Retigabine | Cmax | 370.0 Nanograms/Milliliter (ng/mL) |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Maximum Observed Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) Following Oral Administration of Ezogabine/Retigabine | Ctau | 105.32 Nanograms/Milliliter (ng/mL) |
| Regimen A: E/R 300/450 mg Then 600 mg | Maximum Observed Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) Following Oral Administration of Ezogabine/Retigabine | Cmax | 535.9 Nanograms/Milliliter (ng/mL) |
| Regimen A: E/R 300/450 mg Then 600 mg | Maximum Observed Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) Following Oral Administration of Ezogabine/Retigabine | Ctau | 199.77 Nanograms/Milliliter (ng/mL) |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Maximum Observed Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) Following Oral Administration of Ezogabine/Retigabine | Cmax | 750.9 Nanograms/Milliliter (ng/mL) |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Maximum Observed Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) Following Oral Administration of Ezogabine/Retigabine | Ctau | 287.48 Nanograms/Milliliter (ng/mL) |
Primary
The Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) Following Oral Administration of Ezogabine/Retigabine
The steady state pharmacokinetic profile following oral administration of ezogabine/retigabine included determining the area under the curve over the dosing interval (AUC\[0-tau\]). The area under the plasma concentration-time curve over the dosing interval (AUC\[0-tau\]) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate AUC(0-tau).
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35
Population: Pharmacokinetic Population: all participants in the All Subjects Population (defined as all participants who received at least one dose of study medication) for whom a pharmacokinetic sample was obtained and analyzed
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | The Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) Following Oral Administration of Ezogabine/Retigabine | 1680.0 Hour*Nanograms/Milliliter (h.ng/mL) |
| Regimen A: E/R 300/450 mg Then 600 mg | The Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) Following Oral Administration of Ezogabine/Retigabine | 2558.8 Hour*Nanograms/Milliliter (h.ng/mL) |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | The Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) Following Oral Administration of Ezogabine/Retigabine | 3783.8 Hour*Nanograms/Milliliter (h.ng/mL) |
Secondary
Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Last Time of Quantifiable Concentration (AUC [0-t]) for the N-acetyl Metabolite of Ezogabine/Retigabine
The area under the curve was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess the plasma n-acetyl metabolite (NAMR) of ezogabine/retigabine following oral administration of ezogabine/retigabine.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Last Time of Quantifiable Concentration (AUC [0-t]) for the N-acetyl Metabolite of Ezogabine/Retigabine | 2222.1 h*ng/mL |
| Regimen A: E/R 300/450 mg Then 600 mg | Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Last Time of Quantifiable Concentration (AUC [0-t]) for the N-acetyl Metabolite of Ezogabine/Retigabine | 3479.2 h*ng/mL |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Last Time of Quantifiable Concentration (AUC [0-t]) for the N-acetyl Metabolite of Ezogabine/Retigabine | 5000.6 h*ng/mL |
Secondary
Change From Baseline in Albumin and Total Protein at Day 7 Post Each Up-titration
Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.
Time frame: Baseline (Screening), Day 7, Day 21, and Day 35
Population: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Albumin and Total Protein at Day 7 Post Each Up-titration | Albumin, n=4, 4, 3 | -3.8 Grams per Liter (G/L) | Standard Deviation 0.96 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Albumin and Total Protein at Day 7 Post Each Up-titration | Total protein, n=4, 4, 3 | -4.0 Grams per Liter (G/L) | Standard Deviation 2.94 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Albumin and Total Protein at Day 7 Post Each Up-titration | Albumin, n=4, 4, 3 | -3.0 Grams per Liter (G/L) | Standard Deviation 3.46 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Albumin and Total Protein at Day 7 Post Each Up-titration | Total protein, n=4, 4, 3 | -3.5 Grams per Liter (G/L) | Standard Deviation 3.79 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Albumin and Total Protein at Day 7 Post Each Up-titration | Albumin, n=4, 4, 3 | -0.7 Grams per Liter (G/L) | Standard Deviation 3.06 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Albumin and Total Protein at Day 7 Post Each Up-titration | Total protein, n=4, 4, 3 | -0.7 Grams per Liter (G/L) | Standard Deviation 5.03 |
Secondary
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Day 7 Post Each Up-titration
Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.
Time frame: Baseline (Screening), Day 7, Day 21, and Day 35
Population: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Day 7 Post Each Up-titration | Alkaline phosphatse, n=4, 4, 3 | -5.8 International Units per Liter (IU/L) | Standard Deviation 16.17 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Day 7 Post Each Up-titration | Alanine amino transferase, n=4, 4, 3 | -2.0 International Units per Liter (IU/L) | Standard Deviation 2.16 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Day 7 Post Each Up-titration | Aspartate amino transferase, n=4, 4, 3 | -0.8 International Units per Liter (IU/L) | Standard Deviation 2.5 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Day 7 Post Each Up-titration | Gamma glutamyl transferase, n=3, 3, 2 | -1.3 International Units per Liter (IU/L) | Standard Deviation 0.58 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Day 7 Post Each Up-titration | Gamma glutamyl transferase, n=3, 3, 2 | 111.0 International Units per Liter (IU/L) | Standard Deviation 181.06 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Day 7 Post Each Up-titration | Alkaline phosphatse, n=4, 4, 3 | 10.3 International Units per Liter (IU/L) | Standard Deviation 35.93 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Day 7 Post Each Up-titration | Aspartate amino transferase, n=4, 4, 3 | 10.8 International Units per Liter (IU/L) | Standard Deviation 17.75 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Day 7 Post Each Up-titration | Alanine amino transferase, n=4, 4, 3 | 35.0 International Units per Liter (IU/L) | Standard Deviation 74.02 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Day 7 Post Each Up-titration | Gamma glutamyl transferase, n=3, 3, 2 | 50.5 International Units per Liter (IU/L) | Standard Deviation 47.38 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Day 7 Post Each Up-titration | Alanine amino transferase, n=4, 4, 3 | -1.0 International Units per Liter (IU/L) | Standard Deviation 2 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Day 7 Post Each Up-titration | Aspartate amino transferase, n=4, 4, 3 | 1.7 International Units per Liter (IU/L) | Standard Deviation 3.21 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Day 7 Post Each Up-titration | Alkaline phosphatse, n=4, 4, 3 | 5.0 International Units per Liter (IU/L) | Standard Deviation 6.93 |
Secondary
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration
Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.
Time frame: Baseline (Screening), Day 7, Day 21, and Day 35
Population: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration | Eosinophils, n=3, 3, 2 | 0.07 Giga (10^9) cells per liter (GI/L) | Standard Deviation 0.059 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration | Total neutrophils, n=3, 3, 2 | 14.90 Giga (10^9) cells per liter (GI/L) | Standard Deviation 24.176 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration | Monocytes, n=3, 3, 2 | -0.04 Giga (10^9) cells per liter (GI/L) | Standard Deviation 0.347 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration | Basophils, n=3, 3, 2 | 0.03 Giga (10^9) cells per liter (GI/L) | Standard Deviation 0.062 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration | White blood cell count, n=4, 4, 3 | 0.393 Giga (10^9) cells per liter (GI/L) | Standard Deviation 1.2125 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration | Platelet count, n=4, 4, 3 | -17.0 Giga (10^9) cells per liter (GI/L) | Standard Deviation 40.12 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration | Lymphocytes, n=3, 3, 2 | 14.77 Giga (10^9) cells per liter (GI/L) | Standard Deviation 26.358 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration | Monocytes, n=3, 3, 2 | 0.09 Giga (10^9) cells per liter (GI/L) | Standard Deviation 0.101 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration | Basophils, n=3, 3, 2 | 0.04 Giga (10^9) cells per liter (GI/L) | Standard Deviation 0.053 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration | Eosinophils, n=3, 3, 2 | 0.09 Giga (10^9) cells per liter (GI/L) | Standard Deviation 0.2 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration | Lymphocytes, n=3, 3, 2 | -0.45 Giga (10^9) cells per liter (GI/L) | Standard Deviation 0.654 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration | Total neutrophils, n=3, 3, 2 | -0.11 Giga (10^9) cells per liter (GI/L) | Standard Deviation 0.37 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration | Platelet count, n=4, 4, 3 | -15.8 Giga (10^9) cells per liter (GI/L) | Standard Deviation 34.32 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration | White blood cell count, n=4, 4, 3 | -0.600 Giga (10^9) cells per liter (GI/L) | Standard Deviation 0.6272 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration | Total neutrophils, n=3, 3, 2 | 0.61 Giga (10^9) cells per liter (GI/L) | Standard Deviation 0.263 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration | Eosinophils, n=3, 3, 2 | 0.10 Giga (10^9) cells per liter (GI/L) | Standard Deviation 0.005 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration | White blood cell count, n=4, 4, 3 | -0.583 Giga (10^9) cells per liter (GI/L) | Standard Deviation 1.3345 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration | Platelet count, n=4, 4, 3 | -1.3 Giga (10^9) cells per liter (GI/L) | Standard Deviation 17.16 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration | Monocytes, n=3, 3, 2 | 0.05 Giga (10^9) cells per liter (GI/L) | Standard Deviation 0.065 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration | Lymphocytes, n=3, 3, 2 | -0.65 Giga (10^9) cells per liter (GI/L) | Standard Deviation 0.918 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration | Basophils, n=3, 3, 2 | 0.00 Giga (10^9) cells per liter (GI/L) | Standard Deviation 0.006 |
Secondary
Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration
Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.
Time frame: Baseline (Screening), Day 7, Day 21, and Day 35
Population: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Calcium, n=4, 4, 3 | 0.00624 Millimoles per liter (MMOL/L) | Standard Deviation 0.062375 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Chloride, n=4, 4, 3 | 1.8 Millimoles per liter (MMOL/L) | Standard Deviation 0.96 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Carbon dioxide content/bicarbonate, n=4, 4, 3 | 0.8 Millimoles per liter (MMOL/L) | Standard Deviation 3.5 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Glucose, n=4, 4, 3 | 0.69388 Millimoles per liter (MMOL/L) | Standard Deviation 1.184069 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Potassium, n=4, 4, 3 | 0.08 Millimoles per liter (MMOL/L) | Standard Deviation 0.206 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Sodium, n=4, 4, 3 | 1.8 Millimoles per liter (MMOL/L) | Standard Deviation 0.5 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Inorganic phosphorus, n=4, 3, 1 | -0.39555 Millimoles per liter (MMOL/L) | Standard Deviation 0.727481 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Urea/BUN, n=4, 4, 3 | -0.3570 Millimoles per liter (MMOL/L) | Standard Deviation 1.23668 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Carbon dioxide content/bicarbonate, n=4, 4, 3 | -1.5 Millimoles per liter (MMOL/L) | Standard Deviation 1.73 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Inorganic phosphorus, n=4, 3, 1 | -0.04305 Millimoles per liter (MMOL/L) | Standard Deviation 0.189202 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Glucose, n=4, 4, 3 | 0.15265 Millimoles per liter (MMOL/L) | Standard Deviation 0.821317 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Potassium, n=4, 4, 3 | 0.17 Millimoles per liter (MMOL/L) | Standard Deviation 0.574 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Sodium, n=4, 4, 3 | 2.0 Millimoles per liter (MMOL/L) | Standard Deviation 1.83 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Calcium, n=4, 4, 3 | -0.04366 Millimoles per liter (MMOL/L) | Standard Deviation 0.117689 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Chloride, n=4, 4, 3 | 3.0 Millimoles per liter (MMOL/L) | Standard Deviation 0.82 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Urea/BUN, n=4, 4, 3 | 0.7140 Millimoles per liter (MMOL/L) | Standard Deviation 0.714 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Carbon dioxide content/bicarbonate, n=4, 4, 3 | -2.7 Millimoles per liter (MMOL/L) | Standard Deviation 2.08 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Chloride, n=4, 4, 3 | 3.0 Millimoles per liter (MMOL/L) | Standard Deviation 1.73 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Calcium, n=4, 4, 3 | 0.02495 Millimoles per liter (MMOL/L) | Standard Deviation 0.194866 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Glucose, n=4, 4, 3 | 0.29605 Millimoles per liter (MMOL/L) | Standard Deviation 0.279394 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Inorganic phosphorus, n=4, 3, 1 | 0.09687 Millimoles per liter (MMOL/L) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Sodium, n=4, 4, 3 | 2.3 Millimoles per liter (MMOL/L) | Standard Deviation 3.06 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Potassium, n=4, 4, 3 | 0.20 Millimoles per liter (MMOL/L) | Standard Deviation 0.624 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Urea/BUN, n=4, 4, 3 | 1.3090 Millimoles per liter (MMOL/L) | Standard Deviation 0.74315 |
Secondary
Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Day 7 Post Each Up-titration
Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.
Time frame: Baseline (Screening), Day 7, Day 21, and Day 35
Population: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Day 7 Post Each Up-titration | Direct bilirubin, n=1, 2, 1 | 2.7360 Micromoles per liter (UMOL/L) | — |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Day 7 Post Each Up-titration | Total bilirubin, n=4, 4, 3 | 0.855 Micromoles per liter (UMOL/L) | Standard Deviation 2.2076 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Day 7 Post Each Up-titration | Creatinine, n=4, 4, 3 | 1.3260 Micromoles per liter (UMOL/L) | Standard Deviation 1.14124 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Day 7 Post Each Up-titration | Uric acid, n=4, 3, 1 | 16.3570 Micromoles per liter (UMOL/L) | Standard Deviation 19.04289 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Day 7 Post Each Up-titration | Uric acid, n=4, 3, 1 | 15.8613 Micromoles per liter (UMOL/L) | Standard Deviation 36.34288 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Day 7 Post Each Up-titration | Direct bilirubin, n=1, 2, 1 | 2.7360 Micromoles per liter (UMOL/L) | Standard Deviation 3.86929 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Day 7 Post Each Up-titration | Creatinine, n=4, 4, 3 | -4.1990 Micromoles per liter (UMOL/L) | Standard Deviation 5.02015 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Day 7 Post Each Up-titration | Total bilirubin, n=4, 4, 3 | 2.138 Micromoles per liter (UMOL/L) | Standard Deviation 2.565 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Day 7 Post Each Up-titration | Uric acid, n=4, 3, 1 | 23.7920 Micromoles per liter (UMOL/L) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Day 7 Post Each Up-titration | Total bilirubin, n=4, 4, 3 | 4.560 Micromoles per liter (UMOL/L) | Standard Deviation 0.9873 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Day 7 Post Each Up-titration | Creatinine, n=4, 4, 3 | 0.5893 Micromoles per liter (UMOL/L) | Standard Deviation 3.34677 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Day 7 Post Each Up-titration | Direct bilirubin, n=1, 2, 1 | -0.8550 Micromoles per liter (UMOL/L) | — |
Secondary
Change From Baseline in Heart Rate (HR)
Vital sign assessment included heart rate measurement and was assessed at Titration 1 (T1; 300 mg/day): Day 1 pre-dose, Day 1 at 3 hours (h), pre-dose and 3 h post-dose. Titration 2 (T2; 450 mg/day): Day 7. Titration 3 (T3; 600 mg/day): pre-dose and 3 h post-dose. Titration 3 Dose Held (T3DH): pre-dose. Titration 4 (T4; 750 mg/day): Day 7. Titration 5 (T5; 900 mg/day): pre-dose and 3 h post-dose. Measurements were taken 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 14 for up-titration to 450 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 28 for up-titration to 750 mg/day dose; Day 35 for up-titration to 900 mg/day dose). Change from baseline was calculated by subtracting the baseline value from the individual post-dose values. Baseline is defined as as the Day 1 pre-dose value.
Time frame: Baseline (Screening) and Day 7 post up-titration, up to Day 35
Population: All Subjects Population. Only those par. available at the specified time points were analyzed(represented by n=X, X, X, X, X in the category titles). Different par. may have been analyzed at different time points and for different parameters, so the overall number of par. analyzed reflects everyone in the All Subjects Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Heart Rate (HR) | HR, T1, 3h, n=5, 0, 0, 0, 0 | 2.8 Beats per Minute (BPM) | Standard Deviation 5.89 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Heart Rate (HR) | HR, T3DH, Pre-dose, n=0, 0, 1, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Heart Rate (HR) | HR, T2, Day 7, n=0, 5, 0, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Heart Rate (HR) | HR, T5, 3h, n=0, 0, 0, 0, 3 | NA Beats per Minute (BPM) | — |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Heart Rate (HR) | HR, T5, Pre-dose, n=0, 0, 0, 0, 3 | NA Beats per Minute (BPM) | — |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Heart Rate (HR) | HR, T1, Pre-dose, n=5, 0, 0, 0, 0 | -0.8 Beats per Minute (BPM) | Standard Deviation 7.22 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Heart Rate (HR) | HR, T1, Day 1 3h, n=5, 0, 0, 0, 0 | 3.6 Beats per Minute (BPM) | Standard Deviation 11.26 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Heart Rate (HR) | HR, T4, Day 7, n=0, 0, 0, 4, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Heart Rate (HR) | HR, T3, 3h, n=0, 0, 4, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Heart Rate (HR) | HR, T3, Pre-dose, n=0, 0, 4, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Heart Rate (HR) | HR, T1, Pre-dose, n=5, 0, 0, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Heart Rate (HR) | HR, T1, Day 1 3h, n=5, 0, 0, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Heart Rate (HR) | HR, T1, 3h, n=5, 0, 0, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Heart Rate (HR) | HR, T2, Day 7, n=0, 5, 0, 0, 0 | 8.2 Beats per Minute (BPM) | Standard Deviation 11.67 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Heart Rate (HR) | HR, T3, Pre-dose, n=0, 0, 4, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Heart Rate (HR) | HR, T3, 3h, n=0, 0, 4, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Heart Rate (HR) | HR, T4, Day 7, n=0, 0, 0, 4, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Heart Rate (HR) | HR, T5, Pre-dose, n=0, 0, 0, 0, 3 | NA Beats per Minute (BPM) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Heart Rate (HR) | HR, T5, 3h, n=0, 0, 0, 0, 3 | NA Beats per Minute (BPM) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Heart Rate (HR) | HR, T3DH, Pre-dose, n=0, 0, 1, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Heart Rate (HR) | HR, T1, Day 1 3h, n=5, 0, 0, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Heart Rate (HR) | HR, T3, Pre-dose, n=0, 0, 4, 0, 0 | 0.5 Beats per Minute (BPM) | Standard Deviation 7.51 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Heart Rate (HR) | HR, T1, 3h, n=5, 0, 0, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Heart Rate (HR) | HR, T2, Day 7, n=0, 5, 0, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Heart Rate (HR) | HR, T5, 3h, n=0, 0, 0, 0, 3 | NA Beats per Minute (BPM) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Heart Rate (HR) | HR, T3, 3h, n=0, 0, 4, 0, 0 | 6.0 Beats per Minute (BPM) | Standard Deviation 5.48 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Heart Rate (HR) | HR, T1, Pre-dose, n=5, 0, 0, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Heart Rate (HR) | HR, T4, Day 7, n=0, 0, 0, 4, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Heart Rate (HR) | HR, T3DH, Pre-dose, n=0, 0, 1, 0, 0 | 8.0 Beats per Minute (BPM) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Heart Rate (HR) | HR, T5, Pre-dose, n=0, 0, 0, 0, 3 | NA Beats per Minute (BPM) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Heart Rate (HR) | HR, T3DH, Pre-dose, n=0, 0, 1, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Heart Rate (HR) | HR, T5, Pre-dose, n=0, 0, 0, 0, 3 | NA Beats per Minute (BPM) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Heart Rate (HR) | HR, T3, 3h, n=0, 0, 4, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Heart Rate (HR) | HR, T1, 3h, n=5, 0, 0, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Heart Rate (HR) | HR, T1, Pre-dose, n=5, 0, 0, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Heart Rate (HR) | HR, T3, Pre-dose, n=0, 0, 4, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Heart Rate (HR) | HR, T1, Day 1 3h, n=5, 0, 0, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Heart Rate (HR) | HR, T4, Day 7, n=0, 0, 0, 4, 0 | 1.8 Beats per Minute (BPM) | Standard Deviation 6.18 |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Heart Rate (HR) | HR, T2, Day 7, n=0, 5, 0, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Heart Rate (HR) | HR, T5, 3h, n=0, 0, 0, 0, 3 | NA Beats per Minute (BPM) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Heart Rate (HR) | HR, T2, Day 7, n=0, 5, 0, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Heart Rate (HR) | HR, T3, Pre-dose, n=0, 0, 4, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Heart Rate (HR) | HR, T3DH, Pre-dose, n=0, 0, 1, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Heart Rate (HR) | HR, T3, 3h, n=0, 0, 4, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Heart Rate (HR) | HR, T4, Day 7, n=0, 0, 0, 4, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Heart Rate (HR) | HR, T1, Day 1 3h, n=5, 0, 0, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Heart Rate (HR) | HR, T5, 3h, n=0, 0, 0, 0, 3 | 2.3 Beats per Minute (BPM) | Standard Deviation 4.16 |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Heart Rate (HR) | HR, T5, Pre-dose, n=0, 0, 0, 0, 3 | 1.7 Beats per Minute (BPM) | Standard Deviation 4.16 |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Heart Rate (HR) | HR, T1, 3h, n=5, 0, 0, 0, 0 | NA Beats per Minute (BPM) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Heart Rate (HR) | HR, T1, Pre-dose, n=5, 0, 0, 0, 0 | NA Beats per Minute (BPM) | — |
Secondary
Change From Baseline in Hematocrit at Day 7 Post Each Up-titration
Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit. The International System of Units (SI) Fraction of one unit (1) is reported here.
Time frame: Baseline (Screening), Day 7, Day 21, and Day 35
Population: All Subjects Population. Only those participants available at the specified time point were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Hematocrit at Day 7 Post Each Up-titration | -0.0057 Fraction of one unit (1) | Standard Deviation 0.01452 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Hematocrit at Day 7 Post Each Up-titration | -0.0303 Fraction of one unit (1) | Standard Deviation 0.02198 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Hematocrit at Day 7 Post Each Up-titration | 0.0017 Fraction of one unit (1) | Standard Deviation 0.1201 |
Secondary
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration at Day 7 Post Each Up-titration
Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.
Time frame: Baseline (Screening), Day 7, Day 21, and Day 35
Population: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration at Day 7 Post Each Up-titration | Hemoglobin, n=4, 4, 3 | -3.0 Grams per liter (G/L) | Standard Deviation 4.9 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration at Day 7 Post Each Up-titration | Mean corpuscle hemoglobin concentration, n=4, 4, 3 | -2.5 Grams per liter (G/L) | Standard Deviation 2.38 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration at Day 7 Post Each Up-titration | Hemoglobin, n=4, 4, 3 | -10.3 Grams per liter (G/L) | Standard Deviation 6.85 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration at Day 7 Post Each Up-titration | Mean corpuscle hemoglobin concentration, n=4, 4, 3 | 0.3 Grams per liter (G/L) | Standard Deviation 10.59 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration at Day 7 Post Each Up-titration | Hemoglobin, n=4, 4, 3 | -2.0 Grams per liter (G/L) | Standard Deviation 4.36 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration at Day 7 Post Each Up-titration | Mean corpuscle hemoglobin concentration, n=4, 4, 3 | -6.7 Grams per liter (G/L) | Standard Deviation 4.93 |
Secondary
Change From Baseline in Mean Corpuscle Hemoglobin at Day 7 Post Each Up-titration
Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.
Time frame: Baseline (Screening), Day 7, Day 21, and Day 35
Population: All Subjects Population. Only those participants available at the specified time point were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Mean Corpuscle Hemoglobin at Day 7 Post Each Up-titration | -0.07 Picograms (PG) per cell (PG/cell) | Standard Deviation 0.126 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Mean Corpuscle Hemoglobin at Day 7 Post Each Up-titration | 0.15 Picograms (PG) per cell (PG/cell) | Standard Deviation 0.569 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Mean Corpuscle Hemoglobin at Day 7 Post Each Up-titration | -0.23 Picograms (PG) per cell (PG/cell) | Standard Deviation 0.153 |
Secondary
Change From Baseline in Mean Corpuscle Volume at Day 7 Post Each Up-titration
Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.
Time frame: Baseline (Screening), Day 7, Day 21, and Day 35
Population: All Subjects Population. Only those participants available at the specified time point were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Mean Corpuscle Volume at Day 7 Post Each Up-titration | 0.52 Femtoliters (FL) | Standard Deviation 1.056 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Mean Corpuscle Volume at Day 7 Post Each Up-titration | 0.45 Femtoliters (FL) | Standard Deviation 1.034 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Mean Corpuscle Volume at Day 7 Post Each Up-titration | 1.00 Femtoliters (FL) | Standard Deviation 1 |
Secondary
Change From Baseline in Post Void Residual Ultrasound at Day 21
A post void residual (PVR) bladder ultrasound was carried out as a measure of bladder function. PVR was clinically indicated following the occurrence of adverse events relating to the lower urinary tract (e.g., micturition difficulties, including urinary hesitancy or urinary retention). These assessments were also repeated following drug withdrawal following such events. A prompt follow-up PVR was recommended if a high score was obtained from a participant on the Pediatric Lower Urinary Tract Symptom scale (the PLUTS scale is a clinician-rated scale used to assess lower urinary tract symptoms, including urinary retention) and if the clinician felt that the participant was at risk or had symptoms of urinary retention. PVR was measured at Day 7 of Titration 3 (600 mg/day). Baseline is defined as the Screening visit.
Time frame: Screening and Day 7 of Titration 3 (Day 21)
Population: All Subjects Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Post Void Residual Ultrasound at Day 21 | 14.4 ML | Standard Deviation 21 |
Secondary
Change From Baseline in Red Blood Cell Count at Day 7 Post Each Up-titration
Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.
Time frame: Baseline (Screening), Day 7, Day 21, and Day 35
Population: All Subjects Population. Only those participants available at the specified time point were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Red Blood Cell Count at Day 7 Post Each Up-titration | -0.090 10^12 cells/L (TI/L) | Standard Deviation 0.1463 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Red Blood Cell Count at Day 7 Post Each Up-titration | -0.357 10^12 cells/L (TI/L) | Standard Deviation 0.2304 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Red Blood Cell Count at Day 7 Post Each Up-titration | -0.030 10^12 cells/L (TI/L) | Standard Deviation 0.1136 |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
Vital sign assessment included the measurement of systolic and diastolic blood pressure at Titration 1 (T1; 300 mg/day): Day 1 pre-dose, Day 1 at 3 hours (h), Day 7 pre-dose, and 3 h post dose. Titration 2 (T2; 450 mg/day): Day 7. Titration 3 (T3; 600 mg/day): Day 21 pre-dose and 3 h post-dose. Titration 3 Dose Held (T3DH): pre-dose. Titration 4 (T4; 750 mg/day): Day 7. Titration 5 (T5; 900 mg/day): Day 35 pre-dose and 3 h post-dose. Measurements were taken 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 14 for up-titration to 450 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 28 for up-titration to 750 mg/day dose; Day 35 for up-titration to 900 mg/day dose). Change from baseline was calculated by subtracting the baseline value from the individual post-dose values. Baseline is defined as as the Day 1 pre-dose value.
Time frame: Baseline (Screening) and Day 7 post up-titration, up to Day 35
Population: All Subjects Population. Only those par. available at the specified time points were analyzed(represented by n=X, X, X, X, X in the category titles). Different par. may have been analyzed at different time points and for different parameters, so the overall number of par. analyzed reflects everyone in the All Subjects Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T1, 3h, n=5, 0, 0, 0, 0 | 4.4 Millimeters of Mercury (mmHg) | Standard Deviation 5.81 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T5, Day 35 Pre-dose, n=0, 0, 0, 0, 3 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T1, Pre-dose, n=5, 0, 0, 0, 0 | 0.2 Millimeters of Mercury (mmHg) | Standard Deviation 4.6 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T5, Day 35 3h, n=0, 0, 0, 0, 3 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T5, Pre-dose, n=0, 0, 0, 0, 3 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T1, Day 1 3h, n=5, 0, 0, 0, 0 | 1.4 Millimeters of Mercury (mmHg) | Standard Deviation 7.92 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T1, Day 7 3h, n=5, 0, 0, 0, 0 | -1.2 Millimeters of Mercury (mmHg) | Standard Deviation 8.81 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T1, Day 1 3h, n=5, 0, 0, 0, 0 | 2.8 Millimeters of Mercury (mmHg) | Standard Deviation 6.02 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T4, Day 7, n=0, 0, 0, 4, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T2, Day 7, n=0, 5, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T3DH, Pre-dose, n=0, 0, 1, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T3, Day 21 Pre-dose, n=0, 0, 4, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T5, 3h, n=0, 0, 0, 0, 3 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T3, 3h, n=0, 0, 4, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T3, Day 21 3h, n=0, 0, 4, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T1, Day 7 Pre-dose, n=5, 0, 0, 0, 0 | 2.6 Millimeters of Mercury (mmHg) | Standard Deviation 5.18 |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T3, Pre-dose, n=0, 0, 4, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T3DH, Pre-dose, n=0, 0, 1, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T2, Day 7, n=0, 5, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T4, Day 28, n=0, 0, 0, 4, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T1, 3h, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T4, Day 28, n=0, 0, 0, 4, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T5, Day 35 Pre-dose, n=0, 0, 0, 0, 3 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T5, Pre-dose, n=0, 0, 0, 0, 3 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T1, Pre-dose, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T3, Day 21 Pre-dose, n=0, 0, 4, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T3DH, Pre-dose, n=0, 0, 1, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T5, Day 35 3h, n=0, 0, 0, 0, 3 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T3, 3h, n=0, 0, 4, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T1, Day 1 3h, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T1, Day 7 Pre-dose, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T2, Day 7, n=0, 5, 0, 0, 0 | -0.2 Millimeters of Mercury (mmHg) | Standard Deviation 15.55 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T1, Day 7 3h, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T3, Day 21 3h, n=0, 0, 4, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T4, Day 7, n=0, 0, 0, 4, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T1, Day 1 3h, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T3, Pre-dose, n=0, 0, 4, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T2, Day 7, n=0, 5, 0, 0, 0 | 5.4 Millimeters of Mercury (mmHg) | Standard Deviation 4.39 |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T5, 3h, n=0, 0, 0, 0, 3 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450 mg Then 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T3DH, Pre-dose, n=0, 0, 1, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T4, Day 7, n=0, 0, 0, 4, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T1, Day 1 3h, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T1, Day 7 Pre-dose, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T1, Day 7 3h, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T2, Day 7, n=0, 5, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T3, Day 21 Pre-dose, n=0, 0, 4, 0, 0 | 11.3 Millimeters of Mercury (mmHg) | Standard Deviation 11.62 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T3, Day 21 3h, n=0, 0, 4, 0, 0 | 3.0 Millimeters of Mercury (mmHg) | Standard Deviation 10.68 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T3DH, Pre-dose, n=0, 0, 1, 0, 0 | 13.0 Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T4, Day 28, n=0, 0, 0, 4, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T5, Day 35 Pre-dose, n=0, 0, 0, 0, 3 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T5, Day 35 3h, n=0, 0, 0, 0, 3 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T1, Day 1 3h, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T1, Pre-dose, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T1, 3h, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T2, Day 7, n=0, 5, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T3, 3h, n=0, 0, 4, 0, 0 | 3.8 Millimeters of Mercury (mmHg) | Standard Deviation 12.89 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T3DH, Pre-dose, n=0, 0, 1, 0, 0 | 23.0 Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T3, Pre-dose, n=0, 0, 4, 0, 0 | 1.8 Millimeters of Mercury (mmHg) | Standard Deviation 4.65 |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T5, Pre-dose, n=0, 0, 0, 0, 3 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T5, 3h, n=0, 0, 0, 0, 3 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T5, Pre-dose, n=0, 0, 0, 0, 3 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T2, Day 7, n=0, 5, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T1, Day 1 3h, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T3DH, Pre-dose, n=0, 0, 1, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T3, Day 21 3h, n=0, 0, 4, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T3, Pre-dose, n=0, 0, 4, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T1, Day 7 3h, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T3DH, Pre-dose, n=0, 0, 1, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T4, Day 7, n=0, 0, 0, 4, 0 | -0.3 Millimeters of Mercury (mmHg) | Standard Deviation 2.99 |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T1, 3h, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T3, Day 21 Pre-dose, n=0, 0, 4, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T2, Day 7, n=0, 5, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T5, Day 35 3h, n=0, 0, 0, 0, 3 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T1, Day 7 Pre-dose, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T1, Day 1 3h, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T3, 3h, n=0, 0, 4, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T4, Day 28, n=0, 0, 0, 4, 0 | 3.0 Millimeters of Mercury (mmHg) | Standard Deviation 3.27 |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T5, Day 35 Pre-dose, n=0, 0, 0, 0, 3 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T5, 3h, n=0, 0, 0, 0, 3 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T1, Pre-dose, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T2, Day 7, n=0, 5, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T4, Day 28, n=0, 0, 0, 4, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T1, 3h, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T3DH, Pre-dose, n=0, 0, 1, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T5, Pre-dose, n=0, 0, 0, 0, 3 | 7.3 Millimeters of Mercury (mmHg) | Standard Deviation 12.7 |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T2, Day 7, n=0, 5, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T3, Day 21 3h, n=0, 0, 4, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T3, Pre-dose, n=0, 0, 4, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T3, Day 21 Pre-dose, n=0, 0, 4, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T1, Day 1 3h, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T3, 3h, n=0, 0, 4, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T1, Pre-dose, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T3DH, Pre-dose, n=0, 0, 1, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T1, Day 7 3h, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T5, 3h, n=0, 0, 0, 0, 3 | 3.7 Millimeters of Mercury (mmHg) | Standard Deviation 16.77 |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T4, Day 7, n=0, 0, 0, 4, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T1, Day 7 Pre-dose, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T5, Day 35 3h, n=0, 0, 0, 0, 3 | 5.3 Millimeters of Mercury (mmHg) | Standard Deviation 10.97 |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, T1, Day 1 3h, n=5, 0, 0, 0, 0 | NA Millimeters of Mercury (mmHg) | — |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, T5, Day 35 Pre-dose, n=0, 0, 0, 0, 3 | 8.7 Millimeters of Mercury (mmHg) | Standard Deviation 13.32 |
Secondary
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
An ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected for heart rate (QTc intervals) was used. Measurements were taken 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 14 for up-titration to 450 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 28 for up-titration to 750 mg/day dose; Day 35 for up-titration to 900 mg/day dose). ECG parameters were assessed at Titration 1 (T1; 300 mg/day): Day 1 pre-dose, Day 1 at 3 hours (h), pre-dose, and 3 h post-dose. Titration 2 (T2; 450 mg/day): Day 7. Titration 3 (T3; 600 mg/day): pre-dose and 3 h post-dose. Titration 3 Dose Held (T3DH): pre-dose. Titration 4 (T4; 750 mg/day): Day 7. Titration 5 (T5; 900 mg/day): pre-dose and 3 h post-dose. The number of participants with abnormal (Abn) clinically significant (CS) and not clinically significant (NCS) ECG findings was recorded. The investigator determined if an ECG finding was CS or NCS.
Time frame: Baseline (Screening) and Day 7 post up-titration, up to Day 35
Population: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T5, 3 h, Abn NCS, n=0, 0, 0, 0, 2 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T5, 3 h, Abn CS, n=0, 0, 0, 0, 2 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3, pre-dose, Abn CS, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T4, Day 7, Abn CS, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, pre-dose, Abn CS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T2, Day 7, Abn CS, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, Day 1 pre-dose, Abn CS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, Day 1 pre-dose, Abn NCS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T4, Day 7, Abn NCS, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, 3 h, Abn NCS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3, 3 h, Abn NCS, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T5, pre-dose, Abn CS, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, Day 1, 3 h, Abn CS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3DH, pre-dose, Abn CS, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, 3 h, Abn CS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3, pre-dose, Abn NCS, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3, 3 h, Abn CS, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, Day 1, 3 h, Abn NCS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3DH, pre-dose, Abn NCS, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T2, Day 7, Abn NCS, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T5, pre-dose, Abn NCS, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, pre-dose, Abn NCS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T5, 3 h, Abn NCS, n=0, 0, 0, 0, 2 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T2, Day 7, Abn CS, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3, 3 h, Abn NCS, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3, pre-dose, Abn NCS, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3, pre-dose, Abn CS, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, Day 1, 3 h, Abn NCS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T5, pre-dose, Abn CS, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, Day 1, 3 h, Abn CS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T5, 3 h, Abn CS, n=0, 0, 0, 0, 2 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T5, pre-dose, Abn NCS, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, pre-dose, Abn NCS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T4, Day 7, Abn CS, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, pre-dose, Abn CS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T4, Day 7, Abn NCS, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, 3 h, Abn NCS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, Day 1 pre-dose, Abn CS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3DH, pre-dose, Abn CS, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, 3 h, Abn CS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, Day 1 pre-dose, Abn NCS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3DH, pre-dose, Abn NCS, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T2, Day 7, Abn NCS, n=0, 5, 0, 0, 0 | 1 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3, 3 h, Abn CS, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T4, Day 7, Abn NCS, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, Day 1 pre-dose, Abn NCS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, Day 1 pre-dose, Abn CS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, Day 1, 3 h, Abn NCS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, Day 1, 3 h, Abn CS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, pre-dose, Abn NCS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, pre-dose, Abn CS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, 3 h, Abn NCS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, 3 h, Abn CS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T2, Day 7, Abn NCS, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T2, Day 7, Abn CS, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3, pre-dose, Abn NCS, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3, pre-dose, Abn CS, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3, 3 h, Abn NCS, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3, 3 h, Abn CS, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3DH, pre-dose, Abn NCS, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3DH, pre-dose, Abn CS, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T4, Day 7, Abn CS, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T5, pre-dose, Abn NCS, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T5, pre-dose, Abn CS, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T5, 3 h, Abn NCS, n=0, 0, 0, 0, 2 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T5, 3 h, Abn CS, n=0, 0, 0, 0, 2 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, Day 1 pre-dose, Abn CS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T4, Day 7, Abn CS, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, 3 h, Abn NCS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T5, 3 h, Abn NCS, n=0, 0, 0, 0, 2 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, Day 1, 3 h, Abn CS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3DH, pre-dose, Abn CS, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T5, pre-dose, Abn NCS, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, 3 h, Abn CS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3, 3 h, Abn CS, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, Day 1, 3 h, Abn NCS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, Day 1 pre-dose, Abn NCS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T5, pre-dose, Abn CS, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, pre-dose, Abn CS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3, pre-dose, Abn NCS, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T5, 3 h, Abn CS, n=0, 0, 0, 0, 2 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3, pre-dose, Abn CS, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T4, Day 7, Abn NCS, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3DH, pre-dose, Abn NCS, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T2, Day 7, Abn CS, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T2, Day 7, Abn NCS, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3, 3 h, Abn NCS, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, pre-dose, Abn NCS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3, 3 h, Abn NCS, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3, 3 h, Abn CS, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, 3 h, Abn CS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T5, 3 h, Abn CS, n=0, 0, 0, 0, 2 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3DH, pre-dose, Abn NCS, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, 3 h, Abn NCS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3DH, pre-dose, Abn CS, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, pre-dose, Abn CS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T4, Day 7, Abn NCS, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, pre-dose, Abn NCS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T5, 3 h, Abn NCS, n=0, 0, 0, 0, 2 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T4, Day 7, Abn CS, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, Day 1, 3 h, Abn CS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, Day 1 pre-dose, Abn NCS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T5, pre-dose, Abn NCS, n=0, 0, 0, 0, 3 | 1 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, Day 1, 3 h, Abn NCS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3, pre-dose, Abn NCS, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T5, pre-dose, Abn CS, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T3, pre-dose, Abn CS, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T2, Day 7, Abn CS, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T1, Day 1 pre-dose, Abn CS, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | T2, Day 7, Abn NCS, n=0, 5, 0, 0, 0 | 1 Participants |
Secondary
Number of Participants With Any Adverse Event (AE)
An AE is defined as 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Time frame: From the start of the first titration until follow-up (assessed up to 46 days)
Population: All Subjects Population: all participants who received at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With Any Adverse Event (AE) | 1 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With Any Adverse Event (AE) | 1 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With Any Adverse Event (AE) | 1 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With Any Adverse Event (AE) | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With Any Adverse Event (AE) | 0 Participants |
Secondary
Number of Participants With the Indicated Neurological Abnormality
Abnormal Central Nervous System (CNS) symptoms were assessed by a full and brief neurological examination. A full neurological examination included assessment of mental status, cranial nerves, gait, coordination, sensation, speech/language, muscle strength, muscle tone, and reflexes. A brief neurological examination included assessment of mental status, cranial nerves, gait, coordination, reflexes, and speech/language. Neurological parameters assessed were memory impairment, impaired intellect, decreased attention, psychomotor slowing, decreased muscle strength, hpertonia, somnolence, right and left bicpes, right and left brachioradialis, right and left knee, right and left ankle, and right and left planter response. Neurological examination was performed at Day 7 of Titration 3 (600 mg/day).
Time frame: Screening and Day 7 of Titration 3 (Day 21)
Population: All Subjects Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Neurological Abnormality | Memory impairment | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Neurological Abnormality | Impaired intellect | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Neurological Abnormality | Decreased attention | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Neurological Abnormality | Psychomotor slowing | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Neurological Abnormality | Decreased muscle strength | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Neurological Abnormality | Hypertonia | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Neurological Abnormality | Somnolence | 1 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Neurological Abnormality | Bicep right | NA Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Neurological Abnormality | Bicep left | NA Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Neurological Abnormality | Brachioradialis right | NA Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Neurological Abnormality | Brachioradialis left | NA Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Neurological Abnormality | Knee right | NA Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Neurological Abnormality | Knee left | NA Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Neurological Abnormality | Ankle right | NA Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Neurological Abnormality | Ankle left | NA Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Neurological Abnormality | Planter response right | NA Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Neurological Abnormality | Planter response left | NA Participants |
Secondary
Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up
Urinalysis parameters analyzed included: urine occult blood (UOB), urine glucose (UG), urine ketones (UK), and urine protein (UP). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test provides results in a semi-quantitative manner, and results can be read as negative (Neg), Trace, and 80, indicating proportional concentrations in the urine sample. Urinalysis parameters were assessed at Titration 1 (T1; 300 mg/day), Titration 2 (T2; 450 mg/day), Titration 3 (T3; 600 mg/day), Titration 4 (T4; 750 mg/day), and Titration 5 (T5; 900 mg/day).
Time frame: Screening, Day 1 (D1), Day 7 (D7), Day 14 (D14), Day 21 (D21), Day 28 (D28), Day 35 (D35), and at the Follow-up Visit (up to Day 46)
Population: All Subjects Population (ASP). Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points and for different parameters, so the overall number of participants analyzed reflects everyone in the ASP.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T4, D7, Trace, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T2, D7, Trace, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D7, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D1, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D7, Trace, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D14, Trace, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T5, D7, 80, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D1, Trace, n=5, 0, 0, 0, 0 | 1 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T5, D7, 80, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D14, 80, n=0, 0,1,0,0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D7, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T4, D7, Negative, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D1, Negative, n=5, 0, 0, 0, 0 | 4 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D7, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D14, Negative, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3,D14, Negative, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D7, Trace, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D1, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T4, D7, Trace, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D14, Trace, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T4, D7, 80, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D7, Negative, n=5, 0, 0, 0, 0 | 5 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T5, D7, Trace, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D7, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T4, D7, 80, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D1, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D1, Negative, n=5, 0, 0, 0, 0 | 5 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T2, D7, Negative, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T5, D7, Negative, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D1, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D1, Negative, n=5, 0, 0, 0, 0 | 4 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D14, Trace, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T5, D7, Negative, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T5, D7, 80, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D7, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D1, Trace, n=5, 0, 0, 0, 0 | 1 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T2, D7, Negative, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D7, 80, n=0, 0, 4, 0,0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T4, D7, Trace, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T5, D7, 80, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D7, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D14, Negative, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T2, D7, 80, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T4, D7, Negative, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D14, 80, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D7, Negative, n=5, 0, 0, 0, 0 | 4 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | Urine Occult Blood, T4, D7, Trace, n=0,0,0,3,0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D7, Negative, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T4, D7, 80, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D1, Negative, n=5, 0, 0, 0, 0 | 5 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D7, Trace, n=5, 0, 0, 0, 0 | 1 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T2, D7, Negative, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T5, D7, Trace, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D14, Trace, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T2, D7, 80, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T2, D7, 80, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T5, D7, Negative, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T5, D7, Trace, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D14, Negative, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T2, D7, 80, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T2, D7, Negative, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D7, Negative, n=5, 0, 0, 0, 0 | 5 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T2, D7, Trace, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D14, 80, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T4, D7, Negative, n=0, 0, 0, 3, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T2, D7, Trace, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | Urine Occult Blood, T4, D7, 80, n=0,0,0,3,0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D7, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D7, Trace, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D1, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D7, 80, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D7, 80, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D14, 80, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D7, Negative, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T5, D7, Trace, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D7, Negative, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D7, Negative, n=5, 0, 0, 0, 0 | 5 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T5, D7, Negative, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D7, 80, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T4, D7, Negative, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D7, Trace, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D7, Negative, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D1, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T2, D7, Trace, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T5, D7, Trace, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D14, 80, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D1, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T2, D7, 80, n=0, 5, 0, 0, 0 | 1 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3,D14, Negative, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D7, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D14, Trace, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D7, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T4, D7, 80, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T5, D7, 80, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D7, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T4, D7, Negative, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D1, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T4, D7, Trace, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D1, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T5, D7, 80, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D1, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D1, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T5, D7, Negative, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T5, D7, Trace, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T4, D7, Trace, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D1, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T4, D7, Negative, n=0, 0, 0, 3, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T4, D7, Negative, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D7, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T4, D7, 80, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D7, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D7, 80, n=0, 0, 4, 0,0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D14, Trace, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D7, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D14, Negative, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T2, D7, 80, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D14, 80, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T2, D7, 80, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T2, D7, Negative, n=0, 5, 0, 0, 0 | 5 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | Urine Occult Blood, T4, D7, Trace, n=0,0,0,3,0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D7, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T2, D7, Trace, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D7, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D7, 80, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T2, D7, Trace, n=0, 5, 0, 0, 0 | 1 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D7, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D7, Negative, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D1, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D7, Trace, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D1, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D14, 80, n=0, 0,1,0,0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T5, D7, 80, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D1, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D14, Negative, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | Urine Occult Blood, T4, D7, 80, n=0,0,0,3,0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T5, D7, Trace, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D14, Trace, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T2, D7, Negative, n=0, 5, 0, 0, 0 | 4 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T5, D7, Negative, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D1, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T5, D7, 80, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D1, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T4, D7, Trace, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D1, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T5, D7, Negative, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T4, D7, Negative, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D7, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D7, Trace, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T4, D7, 80, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D7, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T5, D7, Trace, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D14, Trace, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D7, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D14, Negative, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T2, D7, 80, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D14, 80, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T2, D7, Negative, n=0, 5, 0, 0, 0 | 5 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T2, D7, Negative, n=0, 5, 0, 0, 0 | 3 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D7, Trace, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T2, D7, Trace, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D7, Negative, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D7, Negative, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D7, 80, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T5, D7, Negative, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D7, 80, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D7, Negative, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T2, D7, Trace, n=0, 5, 0, 0, 0 | 1 Participants |
| Regimen A: E/R 300/450 mg Then 600 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D7, Trace, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D14, Trace, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | Urine Occult Blood, T4, D7, 80, n=0,0,0,3,0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T4, D7, Negative, n=0, 0, 0, 3, 0 | 3 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | Urine Occult Blood, T4, D7, Trace, n=0,0,0,3,0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T5, D7, 80, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T5, D7, Negative, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T5, D7, Trace, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D1, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D1, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D1, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D7, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D7, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D7, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T2, D7, 80, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T2, D7, Negative, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T2, D7, Trace, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D7, 80, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D7, Negative, n=0, 0, 4, 0, 0 | 4 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D7, Trace, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D14, 80, n=0, 0,1,0,0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D14, Negative, n=0, 0, 1, 0, 0 | 1 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D14, Trace, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D1, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D1, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D1, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D7, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D7, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D7, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T2, D7, 80, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T2, D7, Negative, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T2, D7, Trace, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D7, 80, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D7, Negative, n=0, 0, 4, 0, 0 | 3 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D7, Trace, n=0, 0, 4, 0, 0 | 1 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D14, 80, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3,D14, Negative, n=0, 0, 1, 0, 0 | 1 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T4, D7, 80, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T4, D7, Negative, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T4, D7, Trace, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T5, D7, 80, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T5, D7, Negative, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T5, D7, Trace, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D1, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D1, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D1, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D7, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D7, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D7, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T2, D7, 80, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T2, D7, Negative, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T2, D7, Trace, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D7, 80, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D7, Negative, n=0, 0, 4, 0, 0 | 4 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D7, Trace, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D14, 80, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D14, Negative, n=0, 0, 1, 0, 0 | 1 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D14, Trace, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T4, D7, 80, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T4, D7, Negative, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T4, D7, Trace, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T5, D7, 80, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T5, D7, Negative, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T5, D7, Trace, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D1, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D1, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D1, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D7, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D7, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D7, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T2, D7, 80, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D14, 80, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D14, Negative, n=0, 0, 1, 0, 0 | 1 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D14, Trace, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T4, D7, 80, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T4, D7, Negative, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T4, D7, Trace, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T5, D7, 80, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T5, D7, Negative, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T5, D7, Trace, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T2, D7, Negative, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T2, D7, Trace, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D7, 80, n=0, 0, 4, 0,0 | 0 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D7, Negative, n=0, 0, 4, 0, 0 | 3 Participants |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D7, Trace, n=0, 0, 4, 0, 0 | 1 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D7, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T2, D7, Negative, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D7, 80, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D14, Trace, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | Urine Occult Blood, T4, D7, Trace, n=0,0,0,3,0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D7, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T4, D7, Negative, n=0, 0, 0, 4, 0 | 4 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T2, D7, Trace, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D7, 80, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D1, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D7, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T5, D7, Negative, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T2, D7, Negative, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T5, D7, Trace, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T2, D7, Trace, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T2, D7, 80, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T4, D7, Trace, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T2, D7, 80, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D14, 80, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D14, 80, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D1, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T2, D7, Trace, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D7, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T2, D7, 80, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D14, Negative, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T5, D7, 80, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T5, D7, Trace, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D7, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T4, D7, Negative, n=0, 0, 0, 3, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D14, Trace, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D1, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D7, Negative, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D7, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D14, Negative, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T4, D7, 80, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T5, D7, Negative, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D7, Trace, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D1, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D7, 80, n=0, 0, 4, 0,0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T4, D7, Negative, n=0, 0, 0, 4, 0 | 4 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D14, Trace, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D7, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T5, D7, 80, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T5, D7, Trace, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T5, D7, Trace, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T5, D7, Negative, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T2, D7, Trace, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D1, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D1, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D14, Negative, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T5, D7, 80, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D7, 80, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D7, Negative, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D1, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D1, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T4, D7, Trace, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D14, Trace, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T4, D7, Trace, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D1, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D14, 80, n=0, 0,1,0,0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T4, D7, Negative, n=0, 0, 0, 4, 0 | 4 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | Urine Occult Blood, T4, D7, 80, n=0,0,0,3,0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T2, D7, Negative, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D7, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D1, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T4, D7, 80, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D7, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D7, Trace, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D7, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D7, Trace, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D7, Trace, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T5, D7, Negative, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D1, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D7, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D1, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3,D14, Negative, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T4, D7, 80, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D7, Negative, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T2, D7, 80, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D7, Negative, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D14, 80, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D7, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T5, D7, 80, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T2, D7, Negative, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T4, D7, Trace, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D7, Negative, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T5, D7, 80, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T2, D7, Trace, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D7, 80, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T5, D7, Trace, n=0, 0, 0, 0, 3 | 1 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D7, 80, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T2, D7, Trace, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D7, Negative, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T2, D7, Negative, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D7, Trace, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T2, D7, 80, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D14, 80, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D7, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T5, D7, Negative, n=0, 0, 0, 0, 3 | 3 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D14, Negative, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D7, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T5, D7, Negative, n=0, 0, 0, 0, 3 | 2 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T3, D14, Trace, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D7, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T4, D7, 80, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D1, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T4, D7, Negative, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D1, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T4, D7, Trace, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T1, D1, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T5, D7, Trace, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T5, D7, 80, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D14, Trace, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T5, D7, 80, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T5, D7, Negative, n=0, 0, 0, 0, 3 | 3 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D14, Negative, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T5, D7, Trace, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D14, 80, n=0, 0,1,0,0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D1, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D7, Trace, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D1, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D7, Negative, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T2, D7, Negative, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D1, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T3, D7, 80, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | Urine Occult Blood, T4, D7, Trace, n=0,0,0,3,0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D7, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T2, D7, Trace, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D7, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T2, D7, Negative, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D7, Negative, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T1, D7, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T2, D7, 80, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T2, D7, 80, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T2, D7, Trace, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D14, 80, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D7, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T4, D7, Negative, n=0, 0, 0, 3, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D14, Negative, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D7, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D14, Trace, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D7, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D14, Trace, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T4, D7, 80, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D1, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T4, D7, Negative, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T5, D7, Negative, n=0, 0, 0, 0, 3 | 3 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D1, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T5, D7, Trace, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T5, D7, 80, n=0, 0, 0, 0, 3 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D1, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T4, D7, Trace, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D7, 80, n=0, 0, 4, 0,0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D1, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T4, D7, Negative, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D1, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T4, D7, 80, n=0, 0, 0, 4, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T2, D7, Negative, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D7, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UP, T3, D7, Trace, n=0, 0, 4, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UG, T1, D1, 80, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D7, Negative, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3,D14, Negative, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T1, D7, Trace, n=5, 0, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D14, 80, n=0, 0, 1, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | Urine Occult Blood, T4, D7, 80, n=0,0,0,3,0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UK, T2, D7, 80, n=0, 5, 0, 0, 0 | 0 Participants |
| Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | UOB, T3, D7, Trace, n=0, 0, 4, 0, 0 | 0 Participants |
Secondary
Percent Change From Baseline in 28-day Seizure Frequency Rate
Participants or their caregivers recorded the number of seizures experienced by the participant, by seizure type (e.g., simple partial seizure \[seizure that affects only a small region of the brain; consciousness is unaffected\], complex partial seizure \[seizure associated with unilateral cerebral hemisphere involvement and causing impairment of awareness or responsiveness\], etc.), as well as by duration of episodes of innumerable seizure activity, in their daily diaries during all phases of this study. Percent change from baseline is defined as 100 \* (rate in a given period minus the baseline rate) / (baseline rate). baseline seizures are defined as those seizures that occurred after Screening and before the start of the treatment. Post-baseline seizures are defined as those seizures that occurred from the start of the treatment until the start of Follow-up. Seizure frequency rate was computed as: 28 \* (number of seizures during given period / number of days in given period).
Time frame: Baseline (Screening) and until Follow-up or early discontinuation (assessed up to 46 days)
Population: All Subjects Population. Only participants with baseline and post-baseline seizure measurements were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Percent Change From Baseline in 28-day Seizure Frequency Rate | -41.5 Percent change | Standard Deviation 29.95 |
Secondary
Plasma Half Life at Steady State (t1/2) Following Oral Administration of Ezogabine/Retigabine
Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess plasma t1/2. Steady-state t1/2 is derived as (Vd/F) / (CL/F), where Vd/F is defined as the apparent volume of distribution after extravascular (e.g., oral) administration, and CL/F is defined as the apparent clearance following oral dosing.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35
Population: PK Population. Only those participants available at the indicated time point were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Plasma Half Life at Steady State (t1/2) Following Oral Administration of Ezogabine/Retigabine | 4.168 Hours |
| Regimen A: E/R 300/450 mg Then 600 mg | Plasma Half Life at Steady State (t1/2) Following Oral Administration of Ezogabine/Retigabine | 5.897 Hours |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Plasma Half Life at Steady State (t1/2) Following Oral Administration of Ezogabine/Retigabine | 3.473 Hours |
Secondary
Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) for the N-acetyl Metabolite of Ezogabine/Retigabine
Ctau refers to the pre-dose (trough) concentration at the end of the dosing interval which is equivalent to the minimum observed concetration (Cmin) at Steady State. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess the Ctau for n-acetyl metabolite (NAMR) of ezogabine/retigabine following oral administration of ezogabine/retigabine.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) for the N-acetyl Metabolite of Ezogabine/Retigabine | 170.51 ng/mL | 95% Confidence Interval 86.32 |
| Regimen A: E/R 300/450 mg Then 600 mg | Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) for the N-acetyl Metabolite of Ezogabine/Retigabine | 307.85 ng/mL | — |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) for the N-acetyl Metabolite of Ezogabine/Retigabine | 415.66 ng/mL | — |
Secondary
Time to Maximum Concentration (Tmax) Following Oral Administration of Ezogabine/Retigabine
Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess plasma Tmax.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35
Population: PK Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Time to Maximum Concentration (Tmax) Following Oral Administration of Ezogabine/Retigabine | 1.000 Hours |
| Regimen A: E/R 300/450 mg Then 600 mg | Time to Maximum Concentration (Tmax) Following Oral Administration of Ezogabine/Retigabine | 1.550 Hours |
| Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Time to Maximum Concentration (Tmax) Following Oral Administration of Ezogabine/Retigabine | 2.000 Hours |