Epilepsy, Partial Seizures, Epilepsy, Primary Generalized Tonic-Clonic Seizures
Conditions
Keywords
safety, partial onset seizures, primary generalized tonic-clonic seizures, pregabalin, pediatric, adult, open-label, long term
Brief summary
Study A0081106 is a 12-month open-label study to evaluate the long term safety and tolerability of pregabalin as add-on therapy in pediatric subjects 1 month to 16 years of age with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with primary generalized tonic-clonic seizures. Pregabalin will be administered in equally divided daily doses for 1 year, in either capsule or liquid oral formulation.
Interventions
DRUGPregabalin
Pregabalin administered as either capsule or liquid oral formulations. Subjects \<4 years of age at Visit 1 will receive study medication 3 times daily (TID) in equally divided doses. Subjects who are ≥4 years of age at Visit 1 will receive study medication twice daily (BID) in equally divided doses. Children less than 17 years of age will receive from 2.5 mg/kg/day to 10.0 mg/kg/day (maximum 600 mg/day. Adults 17 and older will receive from 150 mg/day to 600 mg/day.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NA
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 66 Years
Healthy volunteers
No
Inclusion criteria
* Subjects and/or parent(s)/legally acceptable representative must be considered willing and able to sign consent, and complete daily dosing and seizure diaries and complete all scheduled visits. * Male and female epilepsy subjects, 1 month to 65 years of age inclusive on the date of the Screening Visit. * Diagnosis of epilepsy with seizures classified as simple partial, complex partial, or partial becoming secondarily generalized, or primary generalized tonic-clonic seizures according to the International League Against Epilepsy (ILAE 2010) Diagnosis Criteria. * Partial onset seizure subjects must have had an average of at least 3 seizures per 28 day period in the 3 months prior to screening. * Currently receiving a stable dose of 1 to 3 antiepileptic drugs (stable within 28 days prior to screening).
Exclusion criteria
* Lennox-Gastaut syndrome, Infantile Spasms, Absence seizures, BECT (Benign Epilepsy with Centrotemporal Spikes), and Dravet syndrome, * A current diagnosis of febrile seizures or any febrile seizure within 1 year of screening. * Status epilepticus within 1 year prior to visit 1. * Seizures related to drugs, alcohol, or acute medical illness. * Progressive structural CNS lesion or a progressive encephalopathy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-Days Seizure Rate at Month 12/Early Termination | Month 12/Early Termination | 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. |
| 28-Days Seizure Rate at Month 2 | Month 2 | 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. |
| 28-Days Seizure Rate at Month 4 | Month 4 | 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. |
| 28-Days Seizure Rate at Month 6 | Month 6 | 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. |
| 28-Days Seizure Rate at Month 9 | Month 9 | 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. |
| Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs | Baseline (Day 1) up to 13 Months | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events between first dose of study drug and up to 28 days after last dose of study drug (up to 13 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. |
| Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months | Baseline up to 12 Months | Physical examination assessed: general appearance, dermatological, head and eyes, ears, nose, mouth, and throat, pulmonary, cardiovascular, abdominal, genitourinary (optional), lymphatic, musculoskeletal/extremities. Neurological examination assessed: level of consciousness, mental status, cranial nerve assessment, muscle strength and tone, reflexes, pin prick and vibratory sensation, coordination and gait. Investigator judged clinically significant change from baseline in physical and neurological examination findings. |
| Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities | Baseline up to 12 months | Pre-defined criteria of vital signs abnormalities: maximum (max.) increase or decrease from baseline in sitting/supine systolic blood pressure (SBP) \>=30 millimeter of mercury (mmHg); maximum increase or decrease from baseline in sitting/supine diastolic blood pressure (DBP) \>=20 mmHg. |
| Number of Participants With Tanner Staging Evaluation at Baseline | Baseline (Day 1) | Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). |
| Number of Participants With Tanner Staging Evaluation at Month 12 | Month 12 | Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). |
| Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months | Baseline up to 12 Months | In this outcome measure number of participants with increase and decrease of \>=7% in body weight, from baseline up to 12 months are reported. |
| Absolute Values for Body Height at Baseline | Baseline | — |
| Absolute Values for Body Height at Month 12 | Month 12 | — |
| Number of Participants With Incidence of Laboratory Abnormalities | Baseline up to 12 Months | Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit, red blood cell(RBC) count: \<0.8\*lower limit of normal(LLN), platelet: \<0.5\*LLN/greater than (\>)1.75\*upper limit of normal (ULN), white blood cell (WBC): \<0.6\*LLN/\>1.5\*ULN, lymphocyte, neutrophil- absolute/%:\<0.8\*LLN/\>1.2\*ULN, basophil, eosinophil, monocyte- absolute/%:\>1.2\*ULN; total/direct/indirect bilirubin \>1.5\*ULN, aspartate aminotransferase (AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:\> 3.0\*ULN, total protein, albumin: \<0.8\*LLN/\>1.2\*ULN; thyroxine, thyroid stimulating hormone \<0.8\*LLN/\>1.2\*ULN; cholesterol, triglycerides:\> \>1.3\*ULN; blood urea nitrogen, creatinine:\>1.3\*ULN; sodium \<0.95\*LLN/\>1.05\*ULN, potassium, chloride, calcium: \<0.9\*LLN or \>1.1\*ULN; glucose \<0.6\*LLN/\>1.5\*ULN, creatine kinase\>2.0\*ULN; urine (specific gravity \<1.003/\>1.030, pH \<4.5/\>8, glucose, ketones, protein: \>=1, WBC, RBC:\>=20, bacteria \>20, hyaline casts/casts \>1); prothrombin (PT), PT international ratio\>1.1\*ULN. |
| Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters | Baseline up to 12 Months | Categories for which data is reported are: 1) maximum (max) PR interval increase from baseline (IFB) (millisecond \[msec\]) percent change (PctChg) \>=25/50%; 2) maximum QRS complex increase from baseline (msec) PctChg\>=50%; 3) maximum QTcB interval (Bazett's correction) increase from baseline (msec): change \>=30 to \<60; change \>=60; 4) maximum QTcF interval (Fridericia's correction) increase from baseline (msec): change \>=30 to \<60; change \>=60. 'PctChg\>=25/50%': \>= 25% increase from baseline when baseline ECG parameter is \> 200 msec, and is \>= 50% increase from baseline when baseline ECG parameter is non-missing and \<=200 msec. |
| 28-Days Seizure Rate at Week 1 | Week 1 | 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. |
| 28-Days Seizure Rate at Month 1 | Month 1 | 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Suicidal Behavior as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Baseline (Day 1), Post-baseline up to 12 Months | Number of participants with C-CASA code 1 or 2 or 3 are reported. C-SSRS responses mapping to C-CASA suicidal behavior codes 1, 2, or 3 are as follows: (1) completed suicide; (2) suicide attempt (response of Yes on actual attempt); (3) preparatory acts toward imminent suicidal behavior (Yes on aborted attempt, interrupted attempt, preparatory acts or behavior). |
| Number of Participants as Per Reliable Change Index (RCI) Category for Cogstate Detection Task | Month 12 | CogState brief battery consisted of 2 tasks- detection and pediatric identification task using a laptop computer with external response buttons. Prior tasks, participants were briefed rules, given an interactive demonstration and a sufficient number of practice trials. For each task, participant responded yes using a response button with dominant hand. Participants had to respond as fast and as accurately as possible. Detection task: measured simple reaction time to assess psychomotor function. Participant pressed a YES response key as soon as they detected an event (ie, a card turning face up presented in the center of the computer screen). A participant's RCI was calculated by dividing the change from individual baseline score by (\[square root 2\] times WSD), where WSD is within-subject standard deviation from Cogstate detection task normative data. Improvement in cognition when RCI \<=-1.65, decline in cognition when RCI =\>1.65. |
| Number of Participants as Per Reliable Change Index Category for Cogstate Pediatric Identification Task | Month 12 | CogState brief battery consisted of 2 tasks-detection and pediatric identification task using a laptop computer with external response buttons. Prior tasks, participants were briefed rules, given an interactive demonstration and a sufficient number of practice trials. For each task, participant responded yes using a response button with dominant hand. Participants had to respond as fast and as accurately as possible. Pediatric identification task: measured choice reaction time to assess visual attention. An event (a card turning face up) occurred in center of computer screen and participant decided if event met a predefined and unchanging criterion (is the color of the card black?); answered YES if criterion was met. A participant's RCI was calculated by dividing the change from individual baseline score by (\[square root 2\] times WSD),WSD=within-subject standard deviation from Cogstate task normative data. Improvement in cognition: RCI \<=-1.65, decline in cognition: RCI =\>1.65. |
| Number of Participants With Suicidal Ideation as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Baseline (Day 1), Post-baseline on Day 1 up to 12 Months | Number of participants with C-CASA code 4 are reported. C-SSRS responses mapping to C-CASA suicidal ideation code 4 are as follows: Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act, without specific plan, active suicidal ideation with some intent to act, without specific plan. |
Countries
Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, China, Czechia, France, Germany, Greece, Hungary, India, Israel, Italy, Lebanon, Malaysia, Montenegro, Philippines, Poland, Romania, Russia, Serbia, Singapore, Slovakia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Participant flow
Pre-assignment details
Reporting arms are on basis of pediatric and adult participants who consented to continue from previous studies receiving either pregabalin or placebo and pediatric participants who directly enrolled in this study. Previous studies- A0081041 (NCT01389596), A0081042 (NCT02072824), A0081105 (NCT01747915).
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin: Previous and Current Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>=4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. | 384 |
| Placebo-Previous to Pregabalin-Current Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. | 210 |
| Direct Pregabalin Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age \<4 years and BID when age \>= 4 years. Pediatric participants with body weight \>=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight \<30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. | 11 |
| Total | 605 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 6 | 9 | 3 |
| Overall Study | Approval expiry at site | 1 | 0 | 0 |
| Overall Study | Death | 3 | 3 | 0 |
| Overall Study | Lack of Efficacy | 22 | 16 | 1 |
| Overall Study | Lost to Follow-up | 5 | 2 | 0 |
| Overall Study | Other | 26 | 13 | 0 |
| Overall Study | Protocol Violation | 4 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 19 | 9 | 1 |
Baseline characteristics
| Characteristic | Pregabalin: Previous and Current | Placebo-Previous to Pregabalin-Current | Direct Pregabalin | Total |
|---|---|---|---|---|
| Age, Continuous | 12.56 years STANDARD_DEVIATION 11.43 | 13.03 years STANDARD_DEVIATION 12.39 | 11.80 years STANDARD_DEVIATION 3.87 | 12.71 years STANDARD_DEVIATION 11.67 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 85 Participants | 47 Participants | 1 Participants | 133 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) White | 294 Participants | 160 Participants | 9 Participants | 463 Participants |
| Sex: Female, Male Female | 176 Participants | 103 Participants | 7 Participants | 286 Participants |
| Sex: Female, Male Male | 208 Participants | 107 Participants | 4 Participants | 319 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 384 | 4 / 210 | 0 / 11 |
| other Total, other adverse events | 186 / 384 | 103 / 210 | 10 / 11 |
| serious Total, serious adverse events | 53 / 384 | 23 / 210 | 1 / 11 |
Outcome results
Primary
28-Days Seizure Rate at Month 1
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
Time frame: Month 1
Population: Safety population included participants who took at least 1 dose of the study medication in the study. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin: Previous and Current | 28-Days Seizure Rate at Month 1 | Partial Onset Seizures | 96.39 Seizures Per 28-Days | Standard Deviation 258.09 |
| Pregabalin: Previous and Current | 28-Days Seizure Rate at Month 1 | Primary Generalized Tonic Clonic Seizures | 1.43 Seizures Per 28-Days | Standard Deviation 2.16 |
| Placebo-Previous to Pregabalin-Current | 28-Days Seizure Rate at Month 1 | Partial Onset Seizures | 178.53 Seizures Per 28-Days | Standard Deviation 1114.79 |
| Placebo-Previous to Pregabalin-Current | 28-Days Seizure Rate at Month 1 | Primary Generalized Tonic Clonic Seizures | 1.66 Seizures Per 28-Days | Standard Deviation 2.86 |
| Direct Pregabalin | 28-Days Seizure Rate at Month 1 | Partial Onset Seizures | 33.42 Seizures Per 28-Days | Standard Deviation 54.21 |
Primary
28-Days Seizure Rate at Month 12/Early Termination
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
Time frame: Month 12/Early Termination
Population: Safety population included participants who took at least 1 dose of the study medication in the study. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin: Previous and Current | 28-Days Seizure Rate at Month 12/Early Termination | Partial Onset Seizures | 56.04 Seizures Per 28-Days | Standard Deviation 147.2 |
| Pregabalin: Previous and Current | 28-Days Seizure Rate at Month 12/Early Termination | Primary Generalized Tonic Clonic Seizures | 1.02 Seizures Per 28-Days | Standard Deviation 1.71 |
| Placebo-Previous to Pregabalin-Current | 28-Days Seizure Rate at Month 12/Early Termination | Partial Onset Seizures | 117.88 Seizures Per 28-Days | Standard Deviation 896.4 |
| Placebo-Previous to Pregabalin-Current | 28-Days Seizure Rate at Month 12/Early Termination | Primary Generalized Tonic Clonic Seizures | 1.33 Seizures Per 28-Days | Standard Deviation 3.2 |
| Direct Pregabalin | 28-Days Seizure Rate at Month 12/Early Termination | Partial Onset Seizures | 11.08 Seizures Per 28-Days | Standard Deviation 16.55 |
Primary
28-Days Seizure Rate at Month 2
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
Time frame: Month 2
Population: Safety population included participants who took at least 1 dose of the study medication in the study. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin: Previous and Current | 28-Days Seizure Rate at Month 2 | Primary Generalized Tonic Clonic Seizures | 1.27 Seizures Per 28-Days | Standard Deviation 1.8 |
| Pregabalin: Previous and Current | 28-Days Seizure Rate at Month 2 | Partial Onset Seizures | 79.33 Seizures Per 28-Days | Standard Deviation 196.31 |
| Placebo-Previous to Pregabalin-Current | 28-Days Seizure Rate at Month 2 | Primary Generalized Tonic Clonic Seizures | 1.36 Seizures Per 28-Days | Standard Deviation 2.63 |
| Placebo-Previous to Pregabalin-Current | 28-Days Seizure Rate at Month 2 | Partial Onset Seizures | 89.09 Seizures Per 28-Days | Standard Deviation 579.42 |
| Direct Pregabalin | 28-Days Seizure Rate at Month 2 | Partial Onset Seizures | 22.16 Seizures Per 28-Days | Standard Deviation 46.7 |
Primary
28-Days Seizure Rate at Month 4
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
Time frame: Month 4
Population: Safety population included participants who took at least 1 dose of the study medication in the study. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin: Previous and Current | 28-Days Seizure Rate at Month 4 | Partial Onset Seizures | 67.32 Seizures Per 28-Days | Standard Deviation 190.44 |
| Pregabalin: Previous and Current | 28-Days Seizure Rate at Month 4 | Primary Generalized Tonic Clonic Seizures | 1.09 Seizures Per 28-Days | Standard Deviation 1.88 |
| Placebo-Previous to Pregabalin-Current | 28-Days Seizure Rate at Month 4 | Partial Onset Seizures | 58.33 Seizures Per 28-Days | Standard Deviation 320.32 |
| Placebo-Previous to Pregabalin-Current | 28-Days Seizure Rate at Month 4 | Primary Generalized Tonic Clonic Seizures | 0.72 Seizures Per 28-Days | Standard Deviation 0.91 |
| Direct Pregabalin | 28-Days Seizure Rate at Month 4 | Partial Onset Seizures | 15.45 Seizures Per 28-Days | Standard Deviation 25.23 |
Primary
28-Days Seizure Rate at Month 6
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
Time frame: Month 6
Population: Safety population included participants who took at least 1 dose of the study medication in the study. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin: Previous and Current | 28-Days Seizure Rate at Month 6 | Primary Generalized Tonic Clonic Seizures | 1.02 Seizures Per 28-Days | Standard Deviation 1.61 |
| Pregabalin: Previous and Current | 28-Days Seizure Rate at Month 6 | Partial Onset Seizures | 50.18 Seizures Per 28-Days | Standard Deviation 125.26 |
| Placebo-Previous to Pregabalin-Current | 28-Days Seizure Rate at Month 6 | Primary Generalized Tonic Clonic Seizures | 0.79 Seizures Per 28-Days | Standard Deviation 1.21 |
| Placebo-Previous to Pregabalin-Current | 28-Days Seizure Rate at Month 6 | Partial Onset Seizures | 51.10 Seizures Per 28-Days | Standard Deviation 212.59 |
| Direct Pregabalin | 28-Days Seizure Rate at Month 6 | Partial Onset Seizures | 4.25 Seizures Per 28-Days | Standard Deviation 6.06 |
Primary
28-Days Seizure Rate at Month 9
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
Time frame: Month 9
Population: Safety population included participants who took at least 1 dose of the study medication in the study. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin: Previous and Current | 28-Days Seizure Rate at Month 9 | Partial Onset Seizures | 38.17 Seizures Per 28-Days | Standard Deviation 87.75 |
| Pregabalin: Previous and Current | 28-Days Seizure Rate at Month 9 | Primary Generalized Tonic Clonic Seizures | 0.96 Seizures Per 28-Days | Standard Deviation 1.69 |
| Placebo-Previous to Pregabalin-Current | 28-Days Seizure Rate at Month 9 | Partial Onset Seizures | 43.13 Seizures Per 28-Days | Standard Deviation 141.96 |
| Placebo-Previous to Pregabalin-Current | 28-Days Seizure Rate at Month 9 | Primary Generalized Tonic Clonic Seizures | 0.62 Seizures Per 28-Days | Standard Deviation 0.99 |
| Direct Pregabalin | 28-Days Seizure Rate at Month 9 | Partial Onset Seizures | 3.00 Seizures Per 28-Days | Standard Deviation 3.93 |
Primary
28-Days Seizure Rate at Week 1
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
Time frame: Week 1
Population: Safety population included participants who took at least 1 dose of the study medication in the study. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin: Previous and Current | 28-Days Seizure Rate at Week 1 | Partial Onset Seizures | 102.89 Seizures Per 28-Days | Standard Deviation 235.73 |
| Pregabalin: Previous and Current | 28-Days Seizure Rate at Week 1 | Primary Generalized Tonic Clonic Seizures | 2.07 Seizures Per 28-Days | Standard Deviation 2.98 |
| Placebo-Previous to Pregabalin-Current | 28-Days Seizure Rate at Week 1 | Partial Onset Seizures | 190.45 Seizures Per 28-Days | Standard Deviation 1143.83 |
| Placebo-Previous to Pregabalin-Current | 28-Days Seizure Rate at Week 1 | Primary Generalized Tonic Clonic Seizures | 2.39 Seizures Per 28-Days | Standard Deviation 4.53 |
| Direct Pregabalin | 28-Days Seizure Rate at Week 1 | Partial Onset Seizures | 17.83 Seizures Per 28-Days | Standard Deviation 32.18 |
Primary
Absolute Values for Body Height at Baseline
Time frame: Baseline
Population: Safety population included participants who took at least 1 dose of the study medication in the study. Here,Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin: Previous and Current | Absolute Values for Body Height at Baseline | Age: 2 Years to <4 Years | 92.2 Centimeters | Standard Deviation 7.13 |
| Pregabalin: Previous and Current | Absolute Values for Body Height at Baseline | Age: 1 Month to <2 Years | 74.7 Centimeters | Standard Deviation 7.91 |
| Pregabalin: Previous and Current | Absolute Values for Body Height at Baseline | Age: 10 Years to 16 Years | 153.5 Centimeters | Standard Deviation 14.5 |
| Pregabalin: Previous and Current | Absolute Values for Body Height at Baseline | Age: 4 Years to <10 Years | 119.3 Centimeters | Standard Deviation 15.16 |
| Pregabalin: Previous and Current | Absolute Values for Body Height at Baseline | Age: >=17 Years | 170.4 Centimeters | Standard Deviation 9.18 |
| Placebo-Previous to Pregabalin-Current | Absolute Values for Body Height at Baseline | Age: >=17 Years | 170.7 Centimeters | Standard Deviation 9.99 |
| Placebo-Previous to Pregabalin-Current | Absolute Values for Body Height at Baseline | Age: 1 Month to <2 Years | 74.8 Centimeters | Standard Deviation 8.24 |
| Placebo-Previous to Pregabalin-Current | Absolute Values for Body Height at Baseline | Age: 2 Years to <4 Years | 91.0 Centimeters | Standard Deviation 8.21 |
| Placebo-Previous to Pregabalin-Current | Absolute Values for Body Height at Baseline | Age: 4 Years to <10 Years | 118.5 Centimeters | Standard Deviation 11.36 |
| Placebo-Previous to Pregabalin-Current | Absolute Values for Body Height at Baseline | Age: 10 Years to 16 Years | 154.7 Centimeters | Standard Deviation 11.88 |
| Direct Pregabalin | Absolute Values for Body Height at Baseline | Age: 10 Years to 16 Years | 153.4 Centimeters | Standard Deviation 7.06 |
| Direct Pregabalin | Absolute Values for Body Height at Baseline | Age: 4 Years to <10 Years | 126.0 Centimeters | Standard Deviation 12.6 |
Primary
Absolute Values for Body Height at Month 12
Time frame: Month 12
Population: Safety population included participants who took at least 1 dose of the study medication in the study. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin: Previous and Current | Absolute Values for Body Height at Month 12 | Age: 10 Years to 16 Years | 158.1 Centimeters | Standard Deviation 13.64 |
| Pregabalin: Previous and Current | Absolute Values for Body Height at Month 12 | Age: 2 Years to <4 Years | 99.3 Centimeters | Standard Deviation 7.9 |
| Pregabalin: Previous and Current | Absolute Values for Body Height at Month 12 | Age: >=17 Years | 170.8 Centimeters | Standard Deviation 9.54 |
| Pregabalin: Previous and Current | Absolute Values for Body Height at Month 12 | Age: 4 Years to <10 Years | 128.2 Centimeters | Standard Deviation 15.94 |
| Pregabalin: Previous and Current | Absolute Values for Body Height at Month 12 | Age: 1 Month to <2 Years | 84.4 Centimeters | Standard Deviation 7.27 |
| Placebo-Previous to Pregabalin-Current | Absolute Values for Body Height at Month 12 | Age: >=17 Years | 170.6 Centimeters | Standard Deviation 10.14 |
| Placebo-Previous to Pregabalin-Current | Absolute Values for Body Height at Month 12 | Age: 10 Years to 16 Years | 160.5 Centimeters | Standard Deviation 11.87 |
| Placebo-Previous to Pregabalin-Current | Absolute Values for Body Height at Month 12 | Age: 1 Month to <2 Years | 85.3 Centimeters | Standard Deviation 9.01 |
| Placebo-Previous to Pregabalin-Current | Absolute Values for Body Height at Month 12 | Age: 2 Years to <4 Years | 98.1 Centimeters | Standard Deviation 8.94 |
| Placebo-Previous to Pregabalin-Current | Absolute Values for Body Height at Month 12 | Age: 4 Years to <10 Years | 126.6 Centimeters | Standard Deviation 10.8 |
| Direct Pregabalin | Absolute Values for Body Height at Month 12 | Age: 10 Years to 16 Years | 153.7 Centimeters | Standard Deviation 6.58 |
| Direct Pregabalin | Absolute Values for Body Height at Month 12 | Age: 4 Years to <10 Years | 128.2 Centimeters | Standard Deviation 13.08 |
Primary
Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities
Pre-defined criteria of vital signs abnormalities: maximum (max.) increase or decrease from baseline in sitting/supine systolic blood pressure (SBP) \>=30 millimeter of mercury (mmHg); maximum increase or decrease from baseline in sitting/supine diastolic blood pressure (DBP) \>=20 mmHg.
Time frame: Baseline up to 12 months
Population: Safety population included participants who took at least 1 dose of the study medication in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pregabalin: Previous and Current | Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities | Max. increase from baseline in DBP>=20 mmHg | 34 Participants |
| Pregabalin: Previous and Current | Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities | Max. decrease from baseline in DBP>=20 mmHg | 22 Participants |
| Pregabalin: Previous and Current | Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities | Max. increase from baseline in SBP>=30 mmHg | 9 Participants |
| Pregabalin: Previous and Current | Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities | Max. decrease from baseline in SBP>=30 mmHg | 8 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities | Max. decrease from baseline in SBP>=30 mmHg | 5 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities | Max. increase from baseline in DBP>=20 mmHg | 16 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities | Max. increase from baseline in SBP>=30 mmHg | 1 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities | Max. decrease from baseline in DBP>=20 mmHg | 6 Participants |
| Direct Pregabalin | Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities | Max. decrease from baseline in SBP>=30 mmHg | 0 Participants |
| Direct Pregabalin | Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities | Max. decrease from baseline in DBP>=20 mmHg | 0 Participants |
| Direct Pregabalin | Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities | Max. increase from baseline in SBP>=30 mmHg | 0 Participants |
| Direct Pregabalin | Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities | Max. increase from baseline in DBP>=20 mmHg | 1 Participants |
Primary
Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months
In this outcome measure number of participants with increase and decrease of \>=7% in body weight, from baseline up to 12 months are reported.
Time frame: Baseline up to 12 Months
Population: Safety population included participants who took at least 1 dose of the study medication in the study. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pregabalin: Previous and Current | Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months | Weight increase from baseline >=7% | 290 Participants |
| Pregabalin: Previous and Current | Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months | Weight decrease from baseline >=7% | 2 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months | Weight increase from baseline >=7% | 147 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months | Weight decrease from baseline >=7% | 4 Participants |
| Direct Pregabalin | Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months | Weight increase from baseline >=7% | 8 Participants |
| Direct Pregabalin | Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months | Weight decrease from baseline >=7% | 0 Participants |
Primary
Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months
Physical examination assessed: general appearance, dermatological, head and eyes, ears, nose, mouth, and throat, pulmonary, cardiovascular, abdominal, genitourinary (optional), lymphatic, musculoskeletal/extremities. Neurological examination assessed: level of consciousness, mental status, cranial nerve assessment, muscle strength and tone, reflexes, pin prick and vibratory sensation, coordination and gait. Investigator judged clinically significant change from baseline in physical and neurological examination findings.
Time frame: Baseline up to 12 Months
Population: Safety population included participants who took at least 1 dose of the study medication in the study. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pregabalin: Previous and Current | Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months | Physical Examination | 8 Participants |
| Pregabalin: Previous and Current | Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months | Neurological Examination | 10 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months | Physical Examination | 6 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months | Neurological Examination | 4 Participants |
| Direct Pregabalin | Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months | Physical Examination | 0 Participants |
| Direct Pregabalin | Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months | Neurological Examination | 2 Participants |
Primary
Number of Participants With Incidence of Laboratory Abnormalities
Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit, red blood cell(RBC) count: \<0.8\*lower limit of normal(LLN), platelet: \<0.5\*LLN/greater than (\>)1.75\*upper limit of normal (ULN), white blood cell (WBC): \<0.6\*LLN/\>1.5\*ULN, lymphocyte, neutrophil- absolute/%:\<0.8\*LLN/\>1.2\*ULN, basophil, eosinophil, monocyte- absolute/%:\>1.2\*ULN; total/direct/indirect bilirubin \>1.5\*ULN, aspartate aminotransferase (AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:\> 3.0\*ULN, total protein, albumin: \<0.8\*LLN/\>1.2\*ULN; thyroxine, thyroid stimulating hormone \<0.8\*LLN/\>1.2\*ULN; cholesterol, triglycerides:\> \>1.3\*ULN; blood urea nitrogen, creatinine:\>1.3\*ULN; sodium \<0.95\*LLN/\>1.05\*ULN, potassium, chloride, calcium: \<0.9\*LLN or \>1.1\*ULN; glucose \<0.6\*LLN/\>1.5\*ULN, creatine kinase\>2.0\*ULN; urine (specific gravity \<1.003/\>1.030, pH \<4.5/\>8, glucose, ketones, protein: \>=1, WBC, RBC:\>=20, bacteria \>20, hyaline casts/casts \>1); prothrombin (PT), PT international ratio\>1.1\*ULN.
Time frame: Baseline up to 12 Months
Population: Analysis population included participants who took at least 1 dose of the study medication in the study and were evaluable for laboratory abnormalities.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregabalin: Previous and Current | Number of Participants With Incidence of Laboratory Abnormalities | 297 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Incidence of Laboratory Abnormalities | 164 Participants |
| Direct Pregabalin | Number of Participants With Incidence of Laboratory Abnormalities | 8 Participants |
Primary
Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters
Categories for which data is reported are: 1) maximum (max) PR interval increase from baseline (IFB) (millisecond \[msec\]) percent change (PctChg) \>=25/50%; 2) maximum QRS complex increase from baseline (msec) PctChg\>=50%; 3) maximum QTcB interval (Bazett's correction) increase from baseline (msec): change \>=30 to \<60; change \>=60; 4) maximum QTcF interval (Fridericia's correction) increase from baseline (msec): change \>=30 to \<60; change \>=60. 'PctChg\>=25/50%': \>= 25% increase from baseline when baseline ECG parameter is \> 200 msec, and is \>= 50% increase from baseline when baseline ECG parameter is non-missing and \<=200 msec.
Time frame: Baseline up to 12 Months
Population: Safety population included participants who took at least 1 dose of the study medication in the study. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pregabalin: Previous and Current | Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters | Max PR interval IFB PctChg >=25/50% | 1 Participants |
| Pregabalin: Previous and Current | Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters | Max QTcB interval IFB change >=60 | 0 Participants |
| Pregabalin: Previous and Current | Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters | Max QTcB interval IFB change >=30 - <60 | 29 Participants |
| Pregabalin: Previous and Current | Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters | Max QTcF interval IFB change >=60 | 1 Participants |
| Pregabalin: Previous and Current | Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters | Max QTcF interval IFB change >=30 - <60 | 18 Participants |
| Pregabalin: Previous and Current | Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters | Max QRS complex IFB PctChg >=50% | 0 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters | Max QTcB interval IFB change >=30 - <60 | 11 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters | Max PR interval IFB PctChg >=25/50% | 0 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters | Max QRS complex IFB PctChg >=50% | 0 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters | Max QTcB interval IFB change >=60 | 0 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters | Max QTcF interval IFB change >=30 - <60 | 9 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters | Max QTcF interval IFB change >=60 | 0 Participants |
| Direct Pregabalin | Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters | Max QTcB interval IFB change >=60 | 0 Participants |
| Direct Pregabalin | Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters | Max PR interval IFB PctChg >=25/50% | 0 Participants |
| Direct Pregabalin | Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters | Max QTcF interval IFB change >=60 | 0 Participants |
| Direct Pregabalin | Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters | Max QRS complex IFB PctChg >=50% | 0 Participants |
| Direct Pregabalin | Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters | Max QTcB interval IFB change >=30 - <60 | 0 Participants |
| Direct Pregabalin | Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters | Max QTcF interval IFB change >=30 - <60 | 1 Participants |
Primary
Number of Participants With Tanner Staging Evaluation at Baseline
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time frame: Baseline (Day 1)
Population: Analysis population included who took at least 1 dose of the study medication in the study and with age 4 years to less than 17 years. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Baseline | Breast | Stage 1 | 37 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Baseline | Pubic Hair | Stage 1 | 95 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Baseline | Genitalia | Stage 1 | 50 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Baseline | Breast | Stage 2 | 17 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Baseline | Pubic Hair | Stage 4 | 34 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Baseline | Breast | Missing | 24 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Baseline | Breast | Stage 3 | 15 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Baseline | Genitalia | Missing | 19 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Baseline | Breast | Not Done | 1 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Baseline | Breast | Stage 4 | 19 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Baseline | Genitalia | Stage 5 | 7 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Baseline | Breast | Stage 5 | 9 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Baseline | Pubic Hair | Stage 5 | 16 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Baseline | Genitalia | Not Done | 0 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Baseline | Genitalia | Stage 4 | 13 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Baseline | Pubic Hair | Not Done | 0 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Baseline | Pubic Hair | Stage 3 | 33 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Baseline | Genitalia | Stage 3 | 20 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Baseline | Pubic Hair | Missing | 0 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Baseline | Pubic Hair | Stage 2 | 34 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Baseline | Genitalia | Stage 2 | 24 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Baseline | Genitalia | Stage 5 | 3 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Baseline | Pubic Hair | Stage 1 | 44 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Baseline | Pubic Hair | Stage 2 | 17 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Baseline | Pubic Hair | Stage 3 | 16 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Baseline | Pubic Hair | Stage 4 | 15 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Baseline | Pubic Hair | Stage 5 | 6 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Baseline | Pubic Hair | Not Done | 0 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Baseline | Pubic Hair | Missing | 0 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Baseline | Breast | Stage 1 | 18 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Baseline | Breast | Stage 2 | 8 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Baseline | Breast | Stage 3 | 7 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Baseline | Breast | Stage 4 | 7 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Baseline | Breast | Stage 5 | 3 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Baseline | Breast | Not Done | 0 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Baseline | Breast | Missing | 9 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Baseline | Genitalia | Stage 1 | 23 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Baseline | Genitalia | Stage 2 | 11 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Baseline | Genitalia | Stage 3 | 10 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Baseline | Genitalia | Stage 4 | 7 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Baseline | Genitalia | Not Done | 1 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Baseline | Genitalia | Missing | 9 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Baseline | Breast | Stage 1 | 2 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Baseline | Pubic Hair | Stage 2 | 1 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Baseline | Genitalia | Stage 1 | 2 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Baseline | Pubic Hair | Missing | 0 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Baseline | Genitalia | Missing | 0 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Baseline | Genitalia | Stage 2 | 0 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Baseline | Pubic Hair | Not Done | 2 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Baseline | Genitalia | Not Done | 1 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Baseline | Genitalia | Stage 3 | 0 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Baseline | Pubic Hair | Stage 5 | 2 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Baseline | Pubic Hair | Stage 1 | 4 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Baseline | Genitalia | Stage 4 | 0 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Baseline | Breast | Stage 4 | 0 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Baseline | Pubic Hair | Stage 4 | 0 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Baseline | Breast | Stage 5 | 2 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Baseline | Breast | Stage 3 | 0 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Baseline | Pubic Hair | Stage 3 | 0 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Baseline | Breast | Not Done | 1 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Baseline | Breast | Stage 2 | 1 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Baseline | Genitalia | Stage 5 | 0 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Baseline | Breast | Missing | 0 Participants |
Primary
Number of Participants With Tanner Staging Evaluation at Month 12
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time frame: Month 12
Population: Analysis population included who took at least 1 dose of the study medication in the study and with age 4 years to less than 17 years. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Breast | Stage 1 | 27 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Genitalia | Missing | 0 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Genitalia | Stage 1 | 40 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Breast | Stage 2 | 17 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Genitalia | Stage 5 | 13 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Breast | Missing | 0 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Breast | Stage 3 | 19 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Pubic Hair | Stage 4 | 21 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Breast | Not Done | 0 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Breast | Stage 4 | 7 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Pubic Hair | Stage 2 | 35 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Breast | Stage 5 | 12 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Genitalia | Stage 4 | 9 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Pubic Hair | Stage 5 | 23 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Pubic Hair | Stage 1 | 68 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Pubic Hair | Not Done | 1 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Genitalia | Not Done | 0 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Genitalia | Stage 3 | 20 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Pubic Hair | Missing | 0 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Pubic Hair | Stage 3 | 38 Participants |
| Pregabalin: Previous and Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Genitalia | Stage 2 | 22 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Genitalia | Stage 5 | 6 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Pubic Hair | Stage 1 | 38 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Pubic Hair | Stage 2 | 17 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Pubic Hair | Stage 3 | 12 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Pubic Hair | Stage 4 | 11 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Pubic Hair | Stage 5 | 10 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Pubic Hair | Not Done | 1 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Pubic Hair | Missing | 0 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Breast | Stage 1 | 15 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Breast | Stage 2 | 8 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Breast | Stage 3 | 5 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Breast | Stage 4 | 3 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Breast | Stage 5 | 5 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Breast | Not Done | 1 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Breast | Missing | 0 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Genitalia | Stage 1 | 19 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Genitalia | Stage 2 | 12 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Genitalia | Stage 3 | 10 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Genitalia | Stage 4 | 5 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Genitalia | Not Done | 0 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Tanner Staging Evaluation at Month 12 | Genitalia | Missing | 0 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Month 12 | Breast | Stage 1 | 2 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Month 12 | Pubic Hair | Stage 2 | 1 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Month 12 | Genitalia | Stage 1 | 1 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Month 12 | Pubic Hair | Missing | 0 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Month 12 | Genitalia | Missing | 0 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Month 12 | Genitalia | Stage 2 | 0 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Month 12 | Pubic Hair | Not Done | 1 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Month 12 | Genitalia | Not Done | 0 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Month 12 | Genitalia | Stage 3 | 0 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Month 12 | Pubic Hair | Stage 4 | 0 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Month 12 | Pubic Hair | Stage 1 | 2 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Month 12 | Genitalia | Stage 4 | 0 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Month 12 | Breast | Stage 4 | 0 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Month 12 | Pubic Hair | Stage 3 | 0 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Month 12 | Breast | Stage 5 | 1 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Month 12 | Breast | Stage 3 | 0 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Month 12 | Pubic Hair | Stage 5 | 1 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Month 12 | Breast | Not Done | 0 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Month 12 | Breast | Stage 2 | 1 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Month 12 | Genitalia | Stage 5 | 0 Participants |
| Direct Pregabalin | Number of Participants With Tanner Staging Evaluation at Month 12 | Breast | Missing | 0 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events between first dose of study drug and up to 28 days after last dose of study drug (up to 13 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator.
Time frame: Baseline (Day 1) up to 13 Months
Population: Safety population included participants who took at least 1 dose of the study medication in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pregabalin: Previous and Current | Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs | Participants With AEs | 252 Participants |
| Pregabalin: Previous and Current | Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs | Participants With SAEs | 53 Participants |
| Pregabalin: Previous and Current | Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs | Participants With Treatment Related AEs | 104 Participants |
| Pregabalin: Previous and Current | Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs | Participants With Treatment Related SAEs | 0 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs | Participants With Treatment Related SAEs | 1 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs | Participants With AEs | 140 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs | Participants With Treatment Related AEs | 65 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs | Participants With SAEs | 23 Participants |
| Direct Pregabalin | Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs | Participants With Treatment Related SAEs | 0 Participants |
| Direct Pregabalin | Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs | Participants With SAEs | 1 Participants |
| Direct Pregabalin | Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs | Participants With Treatment Related AEs | 9 Participants |
| Direct Pregabalin | Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs | Participants With AEs | 10 Participants |
Secondary
Number of Participants as Per Reliable Change Index Category for Cogstate Pediatric Identification Task
CogState brief battery consisted of 2 tasks-detection and pediatric identification task using a laptop computer with external response buttons. Prior tasks, participants were briefed rules, given an interactive demonstration and a sufficient number of practice trials. For each task, participant responded yes using a response button with dominant hand. Participants had to respond as fast and as accurately as possible. Pediatric identification task: measured choice reaction time to assess visual attention. An event (a card turning face up) occurred in center of computer screen and participant decided if event met a predefined and unchanging criterion (is the color of the card black?); answered YES if criterion was met. A participant's RCI was calculated by dividing the change from individual baseline score by (\[square root 2\] times WSD),WSD=within-subject standard deviation from Cogstate task normative data. Improvement in cognition: RCI \<=-1.65, decline in cognition: RCI =\>1.65.
Time frame: Month 12
Population: Analysis population included participants who took at least 1 dose of the study medication in the study and were evaluable for cognitive testing. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pregabalin: Previous and Current | Number of Participants as Per Reliable Change Index Category for Cogstate Pediatric Identification Task | Improvement (RCI <=-1.65) | 17 Participants |
| Pregabalin: Previous and Current | Number of Participants as Per Reliable Change Index Category for Cogstate Pediatric Identification Task | Decline (RCI =>1.65) | 16 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants as Per Reliable Change Index Category for Cogstate Pediatric Identification Task | Improvement (RCI <=-1.65) | 9 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants as Per Reliable Change Index Category for Cogstate Pediatric Identification Task | Decline (RCI =>1.65) | 6 Participants |
| Direct Pregabalin | Number of Participants as Per Reliable Change Index Category for Cogstate Pediatric Identification Task | Improvement (RCI <=-1.65) | 2 Participants |
| Direct Pregabalin | Number of Participants as Per Reliable Change Index Category for Cogstate Pediatric Identification Task | Decline (RCI =>1.65) | 2 Participants |
Secondary
Number of Participants as Per Reliable Change Index (RCI) Category for Cogstate Detection Task
CogState brief battery consisted of 2 tasks- detection and pediatric identification task using a laptop computer with external response buttons. Prior tasks, participants were briefed rules, given an interactive demonstration and a sufficient number of practice trials. For each task, participant responded yes using a response button with dominant hand. Participants had to respond as fast and as accurately as possible. Detection task: measured simple reaction time to assess psychomotor function. Participant pressed a YES response key as soon as they detected an event (ie, a card turning face up presented in the center of the computer screen). A participant's RCI was calculated by dividing the change from individual baseline score by (\[square root 2\] times WSD), where WSD is within-subject standard deviation from Cogstate detection task normative data. Improvement in cognition when RCI \<=-1.65, decline in cognition when RCI =\>1.65.
Time frame: Month 12
Population: Analysis population included participants who took at least 1 dose of the study medication in the study and were evaluable for cognitive testing. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pregabalin: Previous and Current | Number of Participants as Per Reliable Change Index (RCI) Category for Cogstate Detection Task | Improvement (RCI <= -1.65) | 21 Participants |
| Pregabalin: Previous and Current | Number of Participants as Per Reliable Change Index (RCI) Category for Cogstate Detection Task | Decline (RCI =>1.65) | 13 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants as Per Reliable Change Index (RCI) Category for Cogstate Detection Task | Improvement (RCI <= -1.65) | 8 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants as Per Reliable Change Index (RCI) Category for Cogstate Detection Task | Decline (RCI =>1.65) | 6 Participants |
| Direct Pregabalin | Number of Participants as Per Reliable Change Index (RCI) Category for Cogstate Detection Task | Improvement (RCI <= -1.65) | 2 Participants |
| Direct Pregabalin | Number of Participants as Per Reliable Change Index (RCI) Category for Cogstate Detection Task | Decline (RCI =>1.65) | 1 Participants |
Secondary
Number of Participants With Suicidal Behavior as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA)
Number of participants with C-CASA code 1 or 2 or 3 are reported. C-SSRS responses mapping to C-CASA suicidal behavior codes 1, 2, or 3 are as follows: (1) completed suicide; (2) suicide attempt (response of Yes on actual attempt); (3) preparatory acts toward imminent suicidal behavior (Yes on aborted attempt, interrupted attempt, preparatory acts or behavior).
Time frame: Baseline (Day 1), Post-baseline up to 12 Months
Population: Analysis population included participants who took at least 1 dose of the study medication in the study and with age \>=6 years. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pregabalin: Previous and Current | Number of Participants With Suicidal Behavior as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Baseline | 1 Participants |
| Pregabalin: Previous and Current | Number of Participants With Suicidal Behavior as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Post-baseline on Day 1 up to 12 Months | 2 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Suicidal Behavior as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Baseline | 1 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Suicidal Behavior as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Post-baseline on Day 1 up to 12 Months | 0 Participants |
| Direct Pregabalin | Number of Participants With Suicidal Behavior as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Baseline | 0 Participants |
| Direct Pregabalin | Number of Participants With Suicidal Behavior as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Post-baseline on Day 1 up to 12 Months | 0 Participants |
Secondary
Number of Participants With Suicidal Ideation as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA)
Number of participants with C-CASA code 4 are reported. C-SSRS responses mapping to C-CASA suicidal ideation code 4 are as follows: Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act, without specific plan, active suicidal ideation with some intent to act, without specific plan.
Time frame: Baseline (Day 1), Post-baseline on Day 1 up to 12 Months
Population: Analysis population included participants who took at least 1 dose of the study medication in the study and with age \>=6 years. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pregabalin: Previous and Current | Number of Participants With Suicidal Ideation as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Baseline | 3 Participants |
| Pregabalin: Previous and Current | Number of Participants With Suicidal Ideation as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Post-baseline on Day 1 up to 12 Months | 3 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Suicidal Ideation as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Baseline | 2 Participants |
| Placebo-Previous to Pregabalin-Current | Number of Participants With Suicidal Ideation as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Post-baseline on Day 1 up to 12 Months | 2 Participants |
| Direct Pregabalin | Number of Participants With Suicidal Ideation as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Baseline | 1 Participants |
| Direct Pregabalin | Number of Participants With Suicidal Ideation as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Post-baseline on Day 1 up to 12 Months | 0 Participants |