Partial Onset Seizures
Conditions
Keywords
Partial Onset Seizures, Epilepsy, Safety, Efficacy, Tolerability, Pregabalin, Lyrica, Adjunctive treatment, Placebo controlled, blinded, Eligibility Criteria
Brief summary
This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to \<4 years of age with refractory partial onset seizures. It is hypothesized that both doses of pregabalin will demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure frequency and that pregabalin will be safe and well tolerated.
Interventions
Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 7.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase
Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 14.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase
DRUGPlacebo
Placebo Liquid dosed three times daily beginning at Randomization through Taper Phase
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Months to 3 Years
Healthy volunteers
No
Inclusion criteria
* Subject must have 3 partial onset seizures in the month prior to screening. * Subject must have 2 partial onset seizures during the 48 hour baseline phase. * Signed Informed Consent. * On 1-3 stable anti-epileptic drugs at screening.
Exclusion criteria
* Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile seizures, and infantile spasms. * Lennox-Gasteau, BECTS, and Dravet's syndrome. * Status epliepticus within 1 year of screening. * Any change in AED regimen with 7 days of screening. * Progressive structural central nervous system (CNS) lesion or a progressive encephalopathy. * Progressive errors of metabolism.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase | Day 1 up to Day 14 | All partial onset seizures experienced during treatment phase were recorded by central reader during the 48 to 72 hour video-electroencephalogram (EEG). Double Blind 24 hour EEG seizure rate for all partial onset seizures = (\[Number of seizures in double blind 48 to 72 hour EEG assessment\] divided by \[number of hours of video-EEG monitoring\])\*24. The EEG assessment was done at the end of the fixed dose treatment. For log-transformation, the quantity 1 was added to the double blind 24 hour EEG seizure rate for all participants to account for any possible 0 seizure incidence. This resulted in final calculation as: log transformed (double-blind 24-hour EEG seizure rate + 1). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase | Day 1 up to Day 14 | Responder Rate was defined as percentage of participants who had a 50% or greater reduction from baseline in 24-hour seizure rate during the double-blind treatment phase. Double Blind 24 hour EEG seizure rate for all partial onset seizures = (\[Number of seizures in double blind 48 to 72 hour EEG assessment\] divided by \[number of hours of video-EEG monitoring\])\*24. The EEG assessment was done at the end of the fixed dose treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events by Severity | Day 1 up to EOS (maximum Day 25) | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories a) mild: AEs does not interfere with participant's usual function b) moderate: AEs interferes to some extent with participant's usual function c) severe: AEs interferes significantly with participant's usual function. |
| Number of Participants With Laboratory Test Abnormalities | From Baseline up to EOS (maximum Day 25) | Abnormality Criteria: hemoglobin,hematocrit,red blood cells(RBC)count:\<0.8\*lower limit of normal\[LLN\],platelets:\<0.5\*LLN/\>1.75\*upper limit of normal\[ULN\]; leukocytes:\<0.6\*LLN/\>1.5\*ULN; lymphocytes,neutrophils, total protein,albumin, tetraiodothyronine,thyroid stimulating hormone:\<0.8\*LLN/\>1.2\*ULN; basophils,eosinophils,monocytes:\>1.2\*ULN; prothrombin \[PT\],PT international ratio:\>1.1\*ULN; aspartate aminotransferase,alanine aminotransferase,alkaline phosphatase,gamma glutamyl transferase:\>0.3\*ULN; bilirubin:\>1.5\*ULN; blood urea nitrogen,creatinine, cholesterol,triglycerides:\>1.3\*ULN; sodium: \<0.95\*LLN/\>1.05\*ULN; potassium,chloride,calcium,bicarbonate:\<0.9\*LLN/\>1.1\*ULN; glucose fasting:\<0.6\*LLN/\>1.5\*ULN; creatine kinase:\>2\*ULN;urine glucose,ketone,protein:\>=1;urine WBC,RBC:\>= 20/High Power Field\[HPF\]; urine casts,hyaline casts:\>1/Low Power Field; urine bacteria:\>20/HPF. |
| Number of Participants With Vital Signs Abnormalities | From Baseline (BL) up to EOS (maximum Day 25) | Criteria for abnormalities in vital signs included: sitting/supine systolic blood pressure (SBP) values: maximum increase and decrease of greater than or equal to (\>=) 30 millimeter of mercury (mmHg) from baseline; sitting/supine diastolic blood pressure (DBP) value: maximum increase and decrease of \>=20 mmHg from baseline. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to End of study (EOS) (maximum Day 25) | 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 AEs were events which occurred between first dose of study drug and up to end of study (up to Day 25) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events. |
| Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Baseline (BL) and EOS (maximum Day 25) | Neurological examinations included: coordination; cranial nerve function (CNF); gait and station; level of consciousness (LOC); lower and upper extremity sensation; muscle strength; muscle tone; nystagmus; reflexes and speech. Abnormalities in neurological examination were based on investigator's discretion and also, some components of the neurological examination were not done for certain participants due to participant age or significant developmental impairment. Only those categories of neurological examination in which at least 10% of participants had an abnormality in any treatment group at any time point were reported in this outcome measure. |
| Number of Participants With Electrocardiogram (ECG) Abnormalities | From screening up to EOS (maximum Day 25) | Criteria for abnormalities in ECG findings: 1) Time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS complex): \>=140 milliseconds (msec); 2) The interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): \>=200 msec; 3) Time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTCF interval): absolute value 450 to \<480 msec, 480 to \<500 msec, \>=500 msec; 4) Maximum QT interval: \>=500 msec; 5) Maximum QTCB interval (Bazett's correction): 450 to\< 480 msec, 480 to \<500 msec, \>=500 msec. Only those categories of ECG abnormalities in which participants were found abnormal (maximum QTCB interval 450-\<480 msec), were reported in this outcome measure. |
| Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Screening and EOS (maximum Day 25) | Physical examinations evaluated the following body systems/organs: abdomen; ears; extremities; eyes; general appearance; head; heart; lungs; lymph nodes; mouth; musculoskeletal; nose; skin and throat. Abnormalities in physical examination were based on investigator's discretion. |
| Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to EOS (maximum Day 25) | Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 AEs were events which occurred between first dose of study drug and up to end of study (up to Day 25) that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to drug was assessed by the investigator. AEs included both serious and non-serious adverse events. |
Countries
Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, China, France, Germany, Greece, Hungary, Israel, Lebanon, Malaysia, Philippines, Romania, Russia, Serbia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United States
Participant flow
Pre-assignment details
Participants received treatment in double-blind treatment phase (total duration: 21 days) which included dose escalation (5 days), fixed-dose (9 days) and taper (7 days).
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day Participants aged \> 3 months to \< 4 years, received Pregabalin 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for first 5 days; followed by 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for 9 days and 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 7 days. | 71 |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day Participants aged \>3 months to \<4 years, received Pregabalin 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for first 2 days and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days; followed by 14 mg/kg/day (12 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for 9 days; and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 4 days and 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days. | 34 |
| Placebo Participants aged \>3 months to \<4 years received placebo matched to Pregabalin, orally TID for 21 days. | 70 |
| Total | 175 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | Insufficient clinical response | 1 | 0 | 1 |
| Overall Study | Medication error | 0 | 1 | 0 |
| Overall Study | No longer willing to participate | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 27.5 months STANDARD_DEVIATION 12.7 | 28.5 months STANDARD_DEVIATION 12.5 | 28.8 months STANDARD_DEVIATION 12.6 | 28.2 months STANDARD_DEVIATION 12.6 |
| Race/Ethnicity, Customized Asian | 23 Participants | 10 Participants | 19 Participants | 52 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 47 Participants | 24 Participants | 49 Participants | 120 Participants |
| Sex: Female, Male Female | 26 Participants | 14 Participants | 32 Participants | 72 Participants |
| Sex: Female, Male Male | 45 Participants | 20 Participants | 38 Participants | 103 Participants |
| Weight | 11.7 kilogram STANDARD_DEVIATION 3.5 | 11.4 kilogram STANDARD_DEVIATION 3.4 | 11.4 kilogram STANDARD_DEVIATION 3.1 | 11.5 kilogram STANDARD_DEVIATION 3.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 0 / 34 | 0 / 70 |
| other Total, other adverse events | 32 / 71 | 16 / 34 | 37 / 70 |
| serious Total, serious adverse events | 0 / 71 | 1 / 34 | 4 / 70 |
Outcome results
Primary
Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase
All partial onset seizures experienced during treatment phase were recorded by central reader during the 48 to 72 hour video-electroencephalogram (EEG). Double Blind 24 hour EEG seizure rate for all partial onset seizures = (\[Number of seizures in double blind 48 to 72 hour EEG assessment\] divided by \[number of hours of video-EEG monitoring\])\*24. The EEG assessment was done at the end of the fixed dose treatment. For log-transformation, the quantity 1 was added to the double blind 24 hour EEG seizure rate for all participants to account for any possible 0 seizure incidence. This resulted in final calculation as: log transformed (double-blind 24-hour EEG seizure rate + 1).
Time frame: Day 1 up to Day 14
Population: Modified intent-to-treat (mITT) population included all randomized participants who took at least one dose of study drug during the double-blind treatment phase, had a baseline with at least one partial onset seizure identified by video-EEG (at least 24 hours of evaluable monitoring) and a treatment phase video-EEG.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase | 1.69 seizures per 24 hours | Standard Error 0.115 |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase | 1.15 seizures per 24 hours | Standard Error 0.163 |
| Placebo | Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase | 1.58 seizures per 24 hours | Standard Error 0.129 |
Comparison: Linear model with log transformed baseline seizure rate as continuous covariate and treatment, age stratum, and geographical region as fixed factor effects.p-value: 0.460695% CI: [-0.19, 0.42]ANCOVA
Comparison: Linear model with log transformed baseline seizure rate as continuous covariate and treatment, age stratum, and geographical region as fixed factor effects.p-value: 0.022395% CI: [-0.8, -0.06]ANCOVA
Secondary
Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase
Responder Rate was defined as percentage of participants who had a 50% or greater reduction from baseline in 24-hour seizure rate during the double-blind treatment phase. Double Blind 24 hour EEG seizure rate for all partial onset seizures = (\[Number of seizures in double blind 48 to 72 hour EEG assessment\] divided by \[number of hours of video-EEG monitoring\])\*24. The EEG assessment was done at the end of the fixed dose treatment.
Time frame: Day 1 up to Day 14
Population: mITT population included all randomized participants who took at least one dose of study drug during the double-blind treatment phase, had a baseline with at least one partial onset seizure identified by Video-EEG (at least 24 hours of evaluable monitoring) and a treatment phase Video-EEG.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase | 30.51 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase | 53.57 percentage of participants |
| Placebo | Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase | 41.51 percentage of participants |
Comparison: The dichotomized responder variable was analyzed using a logistic regression model via maximum likelihood estimation with treatment group, age stratum, and geographical region as a fixed effect covariates.p-value: 0.241895% CI: [0.284, 1.373]Regression, Logistic
Comparison: The dichotomized responder variable was analyzed using a logistic regression model via maximum likelihood estimation with treatment group, age stratum, and geographical region as a fixed effect covariates.p-value: 0.30595% CI: [0.644, 4.086]Regression, Logistic
Other Pre-specified
Number of Adverse Events by Severity
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories a) mild: AEs does not interfere with participant's usual function b) moderate: AEs interferes to some extent with participant's usual function c) severe: AEs interferes significantly with participant's usual function.
Time frame: Day 1 up to EOS (maximum Day 25)
Population: Safety population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Number of Adverse Events by Severity | Moderate | 3 events |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Number of Adverse Events by Severity | Mild | 60 events |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Number of Adverse Events by Severity | Severe | 0 events |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Number of Adverse Events by Severity | Moderate | 13 events |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Number of Adverse Events by Severity | Mild | 23 events |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Number of Adverse Events by Severity | Severe | 0 events |
| Placebo | Number of Adverse Events by Severity | Mild | 67 events |
| Placebo | Number of Adverse Events by Severity | Severe | 0 events |
| Placebo | Number of Adverse Events by Severity | Moderate | 19 events |
Other Pre-specified
Number of Participants With Electrocardiogram (ECG) Abnormalities
Criteria for abnormalities in ECG findings: 1) Time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS complex): \>=140 milliseconds (msec); 2) The interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): \>=200 msec; 3) Time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTCF interval): absolute value 450 to \<480 msec, 480 to \<500 msec, \>=500 msec; 4) Maximum QT interval: \>=500 msec; 5) Maximum QTCB interval (Bazett's correction): 450 to\< 480 msec, 480 to \<500 msec, \>=500 msec. Only those categories of ECG abnormalities in which participants were found abnormal (maximum QTCB interval 450-\<480 msec), were reported in this outcome measure.
Time frame: From screening up to EOS (maximum Day 25)
Population: Safety population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Number of Participants With Electrocardiogram (ECG) Abnormalities | 0 Participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Number of Participants With Electrocardiogram (ECG) Abnormalities | 2 Participants |
| Placebo | Number of Participants With Electrocardiogram (ECG) Abnormalities | 0 Participants |
Other Pre-specified
Number of Participants With Laboratory Test Abnormalities
Abnormality Criteria: hemoglobin,hematocrit,red blood cells(RBC)count:\<0.8\*lower limit of normal\[LLN\],platelets:\<0.5\*LLN/\>1.75\*upper limit of normal\[ULN\]; leukocytes:\<0.6\*LLN/\>1.5\*ULN; lymphocytes,neutrophils, total protein,albumin, tetraiodothyronine,thyroid stimulating hormone:\<0.8\*LLN/\>1.2\*ULN; basophils,eosinophils,monocytes:\>1.2\*ULN; prothrombin \[PT\],PT international ratio:\>1.1\*ULN; aspartate aminotransferase,alanine aminotransferase,alkaline phosphatase,gamma glutamyl transferase:\>0.3\*ULN; bilirubin:\>1.5\*ULN; blood urea nitrogen,creatinine, cholesterol,triglycerides:\>1.3\*ULN; sodium: \<0.95\*LLN/\>1.05\*ULN; potassium,chloride,calcium,bicarbonate:\<0.9\*LLN/\>1.1\*ULN; glucose fasting:\<0.6\*LLN/\>1.5\*ULN; creatine kinase:\>2\*ULN;urine glucose,ketone,protein:\>=1;urine WBC,RBC:\>= 20/High Power Field\[HPF\]; urine casts,hyaline casts:\>1/Low Power Field; urine bacteria:\>20/HPF.
Time frame: From Baseline up to EOS (maximum Day 25)
Population: Safety population included all randomized participants who received at least 1 dose of study drug. Here, Overall number of participants analyzed= number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Number of Participants With Laboratory Test Abnormalities | 65 Participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Number of Participants With Laboratory Test Abnormalities | 29 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | 61 Participants |
Other Pre-specified
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (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 AEs were events which occurred between first dose of study drug and up to end of study (up to Day 25) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.
Time frame: Day 1 up to End of study (EOS) (maximum Day 25)
Population: Safety population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 32 Participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 17 Participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 38 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 4 Participants |
Other Pre-specified
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 AEs were events which occurred between first dose of study drug and up to end of study (up to Day 25) that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to drug was assessed by the investigator. AEs included both serious and non-serious adverse events.
Time frame: Day 1 up to EOS (maximum Day 25)
Population: Safety population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 15 Participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 8 Participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Placebo | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 13 Participants |
| Placebo | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 Participants |
Other Pre-specified
Number of Participants With Vital Signs Abnormalities
Criteria for abnormalities in vital signs included: sitting/supine systolic blood pressure (SBP) values: maximum increase and decrease of greater than or equal to (\>=) 30 millimeter of mercury (mmHg) from baseline; sitting/supine diastolic blood pressure (DBP) value: maximum increase and decrease of \>=20 mmHg from baseline.
Time frame: From Baseline (BL) up to EOS (maximum Day 25)
Population: Safety population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Number of Participants With Vital Signs Abnormalities | Maximum Increase from BL(>=30):sitting/supine SBP | 2 Participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Number of Participants With Vital Signs Abnormalities | Maximum Increase from BL(>=20):sitting/supine DBP | 7 Participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Number of Participants With Vital Signs Abnormalities | Maximum Decrease from BL(>=30):sitting/supine SBP | 1 Participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Number of Participants With Vital Signs Abnormalities | Maximum Decrease from BL(>=20):sitting/supine DBP | 2 Participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Number of Participants With Vital Signs Abnormalities | Maximum Decrease from BL(>=20):sitting/supine DBP | 2 Participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Number of Participants With Vital Signs Abnormalities | Maximum Increase from BL(>=30):sitting/supine SBP | 0 Participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Number of Participants With Vital Signs Abnormalities | Maximum Decrease from BL(>=30):sitting/supine SBP | 0 Participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Number of Participants With Vital Signs Abnormalities | Maximum Increase from BL(>=20):sitting/supine DBP | 1 Participants |
| Placebo | Number of Participants With Vital Signs Abnormalities | Maximum Decrease from BL(>=20):sitting/supine DBP | 1 Participants |
| Placebo | Number of Participants With Vital Signs Abnormalities | Maximum Increase from BL(>=20):sitting/supine DBP | 3 Participants |
| Placebo | Number of Participants With Vital Signs Abnormalities | Maximum Decrease from BL(>=30):sitting/supine SBP | 1 Participants |
| Placebo | Number of Participants With Vital Signs Abnormalities | Maximum Increase from BL(>=30):sitting/supine SBP | 1 Participants |
Other Pre-specified
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Neurological examinations included: coordination; cranial nerve function (CNF); gait and station; level of consciousness (LOC); lower and upper extremity sensation; muscle strength; muscle tone; nystagmus; reflexes and speech. Abnormalities in neurological examination were based on investigator's discretion and also, some components of the neurological examination were not done for certain participants due to participant age or significant developmental impairment. Only those categories of neurological examination in which at least 10% of participants had an abnormality in any treatment group at any time point were reported in this outcome measure.
Time frame: Baseline (BL) and EOS (maximum Day 25)
Population: Safety population included all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies number of participants who were evaluable for the specified category for each arm respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Speech - language (EOS) | 69.0 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Level of consciousness (BL) | 5.6 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Coordination- romberg test (BL) | 2.8 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left triceps (BL) | 46.5 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Gait and station - gait (EOS) | 52.1 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Coordination- romberg test (EOS) | 2.8 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right knee (EOS) | 50.7 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Gait and station - gait (BL) | 52.1 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF- left eye visual field (BL) | 12.7 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left ankle (EOS) | 46.5 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: Left shoulder shrug,head turn strength (EOS) | 11.3 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF- left eye visual field (EOS) | 12.7 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Speech - articulation (EOS) | 54.9 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF:Left shoulder,head turn strength (BL) | 11.3 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: right eye visual field (BL) | 12.7 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right knee (BL) | 52.1 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: swallowing (EOS) | 14.1 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: right eye visual field (EOS) | 12.7 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right ankle (BL) | 46.5 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: swallowing (BL) | 14.1 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: left fundoscopic exam (BL) | 12.7 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle tone - upper extremities (BL) | 64.8 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: finger tracking (EOS) | 21.1 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: left fundoscopic exam (EOS) | 12.7 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left knee (EOS) | 52.1 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: finger tracking (BL) | 22.5 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: right fundoscopic exam (BL) | 11.3 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right ankle (EOS) | 45.1 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: right visual acuity (EOS) | 11.3 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: right fundoscopic exam (EOS) | 11.3 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle tone - lower extremities (BL) | 64.3 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: right visual acuity (BL) | 11.3 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: left visual acuity (BL) | 11.3 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left babinski (BL) | 42.3 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: left visual acuity (EOS) | 11.3 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Speech - articulation (BL) | 53.5 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left knee (BL) | 53.5 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left babinski (EOS) | 40.8 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle tone - upper extremities (EOS) | 64.8 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right brachioradialis (EOS) | 43.7 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right babinski (BL) | 42.3 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle strength - trunk (EOS) | 39.4 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right brachioradialis (BL) | 43.7 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right babinski (EOS) | 40.8 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right triceps (EOS) | 45.1 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left brachioradialis (EOS) | 45.1 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left biceps (BL) | 47.9 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Nystagmus - horizontal (BL) | 9.9 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle strength - trunk (BL) | 43.7 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left biceps (EOS) | 47.9 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Speech - language (BL) | 69.0 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle strength - upper extremities (EOS) | 49.3 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right biceps (BL) | 46.5 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right triceps (BL) | 45.1 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right biceps (EOS) | 46.5 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle strength - upper extremities (BL) | 47.9 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Nystagmus - horizontal (EOS) | 8.5 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle strength -lower extremities (EOS) | 49.3 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left brachioradialis (BL) | 45.1 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle tone - lower extremities (EOS) | 64.8 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Coordination- left hand movement (BL) | 1.4 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left triceps (EOS) | 46.5 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle strength -lower extremities (BL) | 49.3 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Coordination-left hand movement (EOS) | 1.4 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left ankle (BL) | 46.5 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Level of consciousness (EOS) | 7.0 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Coordination- right hand movement (EOS) | 2.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right knee (EOS) | 64.7 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle strength - trunk (EOS) | 38.2 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle tone - lower extremities (BL) | 73.5 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle tone - lower extremities (EOS) | 73.5 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle tone - upper extremities (BL) | 73.5 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle tone - upper extremities (EOS) | 73.5 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Nystagmus - horizontal (BL) | 11.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Nystagmus - horizontal (EOS) | 11.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left ankle (BL) | 52.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left ankle (EOS) | 52.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right ankle (BL) | 58.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right ankle (EOS) | 58.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left babinski (BL) | 47.1 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left babinski (EOS) | 47.1 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right babinski (BL) | 55.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right babinski (EOS) | 55.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left biceps (BL) | 52.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left biceps (EOS) | 52.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right biceps (BL) | 58.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right biceps (EOS) | 58.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left brachioradialis (BL) | 52.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Coordination- left hand movement (BL) | 11.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Coordination-left hand movement (EOS) | 8.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Coordination- right hand movement (EOS) | 5.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Coordination- romberg test (BL) | 8.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Coordination- romberg test (EOS) | 5.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF- left eye visual field (BL) | 8.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF- left eye visual field (EOS) | 8.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: right eye visual field (BL) | 5.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: right eye visual field (EOS) | 5.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: left fundoscopic exam (BL) | 26.5 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: left fundoscopic exam (EOS) | 23.5 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: right fundoscopic exam (BL) | 20.6 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: right fundoscopic exam (EOS) | 17.6 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: left visual acuity (BL) | 11.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: left visual acuity (EOS) | 11.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: right visual acuity (BL) | 11.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: right visual acuity (EOS) | 11.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: finger tracking (BL) | 26.5 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: finger tracking (EOS) | 23.5 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: swallowing (BL) | 14.7 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: swallowing (EOS) | 14.7 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF:Left shoulder,head turn strength (BL) | 2.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: Left shoulder shrug,head turn strength (EOS) | 2.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Gait and station - gait (BL) | 50.0 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Gait and station - gait (EOS) | 52.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Level of consciousness (BL) | 20.6 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Level of consciousness (EOS) | 20.6 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle strength -lower extremities (BL) | 58.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle strength -lower extremities (EOS) | 58.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle strength - upper extremities (BL) | 58.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle strength - upper extremities (EOS) | 58.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle strength - trunk (BL) | 38.2 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left brachioradialis (EOS) | 52.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right brachioradialis (BL) | 58.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right brachioradialis (EOS) | 58.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left knee (BL) | 55.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left knee (EOS) | 58.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right knee (BL) | 61.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left triceps (BL) | 52.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left triceps (EOS) | 52.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right triceps (BL) | 58.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right triceps (EOS) | 58.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Speech - articulation (BL) | 47.1 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Speech - articulation (EOS) | 44.1 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Speech - language (BL) | 76.5 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Speech - language (EOS) | 73.5 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Gait and station - gait (EOS) | 46.4 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Coordination- right hand movement (EOS) | 10.1 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Nystagmus - horizontal (EOS) | 5.8 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Level of consciousness (BL) | 5.7 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Coordination-left hand movement (EOS) | 10.1 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Speech - articulation (EOS) | 47.8 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Level of consciousness (EOS) | 2.9 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Coordination- left hand movement (BL) | 8.6 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left triceps (EOS) | 44.9 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle strength -lower extremities (BL) | 51.4 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right biceps (EOS) | 52.2 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Nystagmus - horizontal (BL) | 7.1 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle strength -lower extremities (EOS) | 53.6 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right biceps (BL) | 52.9 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle tone - lower extremities (BL) | 63.8 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle strength - upper extremities (BL) | 50.0 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left biceps (EOS) | 49.3 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right triceps (BL) | 48.6 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle strength - upper extremities (EOS) | 52.2 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left biceps (BL) | 50.0 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle tone - upper extremities (EOS) | 66.2 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left brachioradialis (BL) | 48.6 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right babinski (EOS) | 50.7 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Speech - language (EOS) | 66.7 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left brachioradialis (EOS) | 47.8 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right babinski (BL) | 50.0 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right triceps (EOS) | 47.8 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right brachioradialis (BL) | 50.0 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left babinski (EOS) | 47.8 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle tone - upper extremities (BL) | 63.8 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right brachioradialis (EOS) | 50.7 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left babinski (BL) | 47.1 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Speech - language (BL) | 65.7 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left knee (BL) | 57.1 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right ankle (BL) | 47.1 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: left visual acuity (BL) | 12.9 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Speech - articulation (BL) | 45.7 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: left visual acuity (EOS) | 13.0 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: right fundoscopic exam (EOS) | 14.5 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left knee (EOS) | 56.5 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: right visual acuity (BL) | 11.4 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: right fundoscopic exam (BL) | 14.3 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left ankle (EOS) | 46.4 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: right visual acuity (EOS) | 11.6 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: left fundoscopic exam (EOS) | 14.5 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle tone - lower extremities (EOS) | 66.2 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: finger tracking (BL) | 24.3 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: left fundoscopic exam (BL) | 12.9 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right knee (BL) | 61.4 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: finger tracking (EOS) | 26.1 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: right eye visual field (EOS) | 10.1 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left ankle (BL) | 47.1 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: swallowing (BL) | 14.3 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: right eye visual field (BL) | 10.0 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle strength - trunk (BL) | 44.3 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: swallowing (EOS) | 14.5 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF- left eye visual field (EOS) | 10.1 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right knee (EOS) | 59.4 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF:Left shoulder,head turn strength (BL) | 7.1 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF- left eye visual field (BL) | 10.0 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - right ankle (EOS) | 46.4 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | CNF: Left shoulder shrug,head turn strength (EOS) | 10.1 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Coordination- romberg test (EOS) | 11.6 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Muscle strength - trunk (EOS) | 42.0 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Gait and station - gait (BL) | 45.7 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Coordination- romberg test (BL) | 10.0 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Reflexes - left triceps (BL) | 45.7 percentage of participants |
Other Pre-specified
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Physical examinations evaluated the following body systems/organs: abdomen; ears; extremities; eyes; general appearance; head; heart; lungs; lymph nodes; mouth; musculoskeletal; nose; skin and throat. Abnormalities in physical examination were based on investigator's discretion.
Time frame: Screening and EOS (maximum Day 25)
Population: Safety population included all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies number of participants who were evaluable for the specified category for each arm respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Skin: Screening | 9.9 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Mouth: Screening | 9.9 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Extremities: EOS | 14.1 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Skin: EOS | 8.5 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Lymph nodes: Screening | 0 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Extremities: Screening | 14.1 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Throat: Screening | 1.4 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Head: EOS | 33.8 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Ears: EOS | 1.4 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Throat: EOS | 0 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Ears: Screening | 1.4 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Abdomen: Screening | 4.2 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Mouth: EOS | 7.1 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Abdomen: EOS | 4.2 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Lungs: EOS | 2.8 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Head: Screening | 31.0 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Musculoskeletal: Screening | 31.0 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Heart: EOS | 1.4 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | General appearance: EOS | 15.5 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Musculoskeletal: EOS | 33.8 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Lymph nodes: EOS | 0 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | General appearance: Screening | 15.5 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Nose: Screening | 0 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Lungs: Screening | 2.8 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Eyes: EOS | 9.9 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Nose: EOS | 0 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Heart: Screening | 1.4 percentage of participants |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Eyes: Screening | 9.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Head: EOS | 47.1 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Lungs: EOS | 8.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Lymph nodes: Screening | 8.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Lymph nodes: EOS | 2.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Mouth: Screening | 2.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Mouth: EOS | 2.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Musculoskeletal: Screening | 38.2 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Musculoskeletal: EOS | 38.2 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Nose: Screening | 2.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Nose: EOS | 0 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Skin: Screening | 14.7 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Skin: EOS | 14.7 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Throat: Screening | 2.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Abdomen: Screening | 5.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Abdomen: EOS | 5.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Ears: Screening | 0 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Ears: EOS | 0 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Extremities: Screening | 26.5 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Extremities: EOS | 26.5 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Eyes: Screening | 20.6 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Eyes: EOS | 20.6 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | General appearance: Screening | 26.5 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | General appearance: EOS | 23.5 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Head: Screening | 47.1 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Throat: EOS | 5.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Heart: Screening | 8.8 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Heart: EOS | 5.9 percentage of participants |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Lungs: Screening | 8.8 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Extremities: EOS | 18.8 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Nose: EOS | 5.8 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Lymph nodes: EOS | 0 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Eyes: Screening | 17.1 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Nose: Screening | 0 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Lungs: EOS | 5.8 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Eyes: EOS | 18.8 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Musculoskeletal: EOS | 37.7 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Heart: Screening | 4.3 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | General appearance: Screening | 15.7 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Musculoskeletal: Screening | 35.7 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Lymph nodes: Screening | 0 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | General appearance: EOS | 15.9 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Mouth: EOS | 5.8 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Abdomen: Screening | 2.9 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Lungs: Screening | 4.3 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Abdomen: EOS | 1.4 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Throat: EOS | 2.9 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Head: Screening | 31.4 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Ears: Screening | 1.4 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Throat: Screening | 0 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Mouth: Screening | 5.7 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Ears: EOS | 1.4 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Skin: EOS | 21.7 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Heart: EOS | 4.3 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Extremities: Screening | 15.7 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Skin: Screening | 21.4 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Head: EOS | 31.9 percentage of participants |