Trial Outcomes & Findings for A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures. (NCT NCT02072824)
NCT ID: NCT02072824
Last Updated: 2021-01-20
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
175 participants
Primary outcome timeframe
Day 1 up to Day 14
Results posted on
2021-01-20
Participant Flow
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).
Participant milestones
| Measure |
Pregabalin 7 mg/kg/Day or 6 mg/kg/Day
Participants aged greater than (\>) 3 months to less than (\<) 4 years, received Pregabalin 3.5 milligrams per kilogram per day (mg/kg/day) (3.0 mg/kg/day for participants 1 to 3 months of age), orally three times daily (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.
|
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.
|
Placebo
Participants aged \>3 months to \<4 years received placebo matched to Pregabalin, orally TID for 21 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
71
|
34
|
70
|
|
Overall Study
COMPLETED
|
69
|
33
|
67
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
3
|
Reasons for withdrawal
| Measure |
Pregabalin 7 mg/kg/Day or 6 mg/kg/Day
Participants aged greater than (\>) 3 months to less than (\<) 4 years, received Pregabalin 3.5 milligrams per kilogram per day (mg/kg/day) (3.0 mg/kg/day for participants 1 to 3 months of age), orally three times daily (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.
|
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.
|
Placebo
Participants aged \>3 months to \<4 years received placebo matched to Pregabalin, orally TID for 21 days.
|
|---|---|---|---|
|
Overall Study
Insufficient clinical response
|
1
|
0
|
1
|
|
Overall Study
No longer willing to participate
|
1
|
0
|
1
|
|
Overall Study
Medication error
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
Baseline characteristics by cohort
| Measure |
Pregabalin 7 mg/kg/Day or 6 mg/kg/Day
n=71 Participants
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.
|
Pregabalin 14 mg/kg/Day or 12 mg/kg/Day
n=34 Participants
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.
|
Placebo
n=70 Participants
Participants aged \>3 months to \<4 years received placebo matched to Pregabalin, orally TID for 21 days.
|
Total
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
27.5 months
STANDARD_DEVIATION 12.7 • n=5 Participants
|
28.5 months
STANDARD_DEVIATION 12.5 • n=7 Participants
|
28.8 months
STANDARD_DEVIATION 12.6 • n=5 Participants
|
28.2 months
STANDARD_DEVIATION 12.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
23 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
47 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Weight
|
11.7 kilogram
STANDARD_DEVIATION 3.5 • n=5 Participants
|
11.4 kilogram
STANDARD_DEVIATION 3.4 • n=7 Participants
|
11.4 kilogram
STANDARD_DEVIATION 3.1 • n=5 Participants
|
11.5 kilogram
STANDARD_DEVIATION 3.3 • n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 14Population: 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.
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).
Outcome measures
| Measure |
Pregabalin 7 mg/kg/Day or 6 mg/kg/Day
n=59 Participants
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.
|
Pregabalin 14 mg/kg/Day or 12 mg/kg/Day
n=28 Participants
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.
|
Placebo
n=53 Participants
Participants aged \>3 months to \<4 years received placebo matched to Pregabalin, orally TID for 21 days.
|
|---|---|---|---|
|
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
|
1.15 seizures per 24 hours
Standard Error 0.163
|
1.58 seizures per 24 hours
Standard Error 0.129
|
SECONDARY outcome
Timeframe: Day 1 up to Day 14Population: 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.
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.
Outcome measures
| Measure |
Pregabalin 7 mg/kg/Day or 6 mg/kg/Day
n=59 Participants
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.
|
Pregabalin 14 mg/kg/Day or 12 mg/kg/Day
n=28 Participants
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.
|
Placebo
n=53 Participants
Participants aged \>3 months to \<4 years received placebo matched to Pregabalin, orally TID for 21 days.
|
|---|---|---|---|
|
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
|
53.57 percentage of participants
|
41.51 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Pregabalin 7 mg/kg/Day or 6 mg/kg/Day
n=71 Participants
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.
|
Pregabalin 14 mg/kg/Day or 12 mg/kg/Day
n=34 Participants
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.
|
Placebo
n=70 Participants
Participants aged \>3 months to \<4 years received placebo matched to Pregabalin, orally TID for 21 days.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
32 Participants
|
17 Participants
|
38 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
1 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 up to EOS (maximum Day 25)Population: Safety population included all randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Pregabalin 7 mg/kg/Day or 6 mg/kg/Day
n=71 Participants
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.
|
Pregabalin 14 mg/kg/Day or 12 mg/kg/Day
n=34 Participants
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.
|
Placebo
n=70 Participants
Participants aged \>3 months to \<4 years received placebo matched to Pregabalin, orally TID for 21 days.
|
|---|---|---|---|
|
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
15 Participants
|
8 Participants
|
13 Participants
|
|
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 up to EOS (maximum Day 25)Population: Safety population included all randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Pregabalin 7 mg/kg/Day or 6 mg/kg/Day
n=71 Participants
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.
|
Pregabalin 14 mg/kg/Day or 12 mg/kg/Day
n=34 Participants
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.
|
Placebo
n=70 Participants
Participants aged \>3 months to \<4 years received placebo matched to Pregabalin, orally TID for 21 days.
|
|---|---|---|---|
|
Number of Adverse Events by Severity
Mild
|
60 events
|
23 events
|
67 events
|
|
Number of Adverse Events by Severity
Moderate
|
3 events
|
13 events
|
19 events
|
|
Number of Adverse Events by Severity
Severe
|
0 events
|
0 events
|
0 events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Pregabalin 7 mg/kg/Day or 6 mg/kg/Day
n=71 Participants
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.
|
Pregabalin 14 mg/kg/Day or 12 mg/kg/Day
n=34 Participants
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.
|
Placebo
n=69 Participants
Participants aged \>3 months to \<4 years received placebo matched to Pregabalin, orally TID for 21 days.
|
|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
|
65 Participants
|
29 Participants
|
61 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Pregabalin 7 mg/kg/Day or 6 mg/kg/Day
n=71 Participants
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.
|
Pregabalin 14 mg/kg/Day or 12 mg/kg/Day
n=34 Participants
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.
|
Placebo
n=70 Participants
Participants aged \>3 months to \<4 years received placebo matched to Pregabalin, orally TID for 21 days.
|
|---|---|---|---|
|
Number of Participants With Vital Signs Abnormalities
Maximum Increase from BL(>=30):sitting/supine SBP
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Abnormalities
Maximum Increase from BL(>=20):sitting/supine DBP
|
7 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Vital Signs Abnormalities
Maximum Decrease from BL(>=30):sitting/supine SBP
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Abnormalities
Maximum Decrease from BL(>=20):sitting/supine DBP
|
2 Participants
|
2 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Pregabalin 7 mg/kg/Day or 6 mg/kg/Day
n=71 Participants
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.
|
Pregabalin 14 mg/kg/Day or 12 mg/kg/Day
n=34 Participants
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.
|
Placebo
n=70 Participants
Participants aged \>3 months to \<4 years received placebo matched to Pregabalin, orally TID for 21 days.
|
|---|---|---|---|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Eyes: EOS
|
9.9 percentage of participants
|
20.6 percentage of participants
|
18.8 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
General appearance: Screening
|
15.5 percentage of participants
|
26.5 percentage of participants
|
15.7 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
General appearance: EOS
|
15.5 percentage of participants
|
23.5 percentage of participants
|
15.9 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Abdomen: Screening
|
4.2 percentage of participants
|
5.9 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Abdomen: EOS
|
4.2 percentage of participants
|
5.9 percentage of participants
|
1.4 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Ears: Screening
|
1.4 percentage of participants
|
0 percentage of participants
|
1.4 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Ears: EOS
|
1.4 percentage of participants
|
0 percentage of participants
|
1.4 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Extremities: Screening
|
14.1 percentage of participants
|
26.5 percentage of participants
|
15.7 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Extremities: EOS
|
14.1 percentage of participants
|
26.5 percentage of participants
|
18.8 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Eyes: Screening
|
9.9 percentage of participants
|
20.6 percentage of participants
|
17.1 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Head: Screening
|
31.0 percentage of participants
|
47.1 percentage of participants
|
31.4 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Head: EOS
|
33.8 percentage of participants
|
47.1 percentage of participants
|
31.9 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Heart: Screening
|
1.4 percentage of participants
|
8.8 percentage of participants
|
4.3 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Heart: EOS
|
1.4 percentage of participants
|
5.9 percentage of participants
|
4.3 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Lungs: Screening
|
2.8 percentage of participants
|
8.8 percentage of participants
|
4.3 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Lungs: EOS
|
2.8 percentage of participants
|
8.8 percentage of participants
|
5.8 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Lymph nodes: Screening
|
0 percentage of participants
|
8.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Lymph nodes: EOS
|
0 percentage of participants
|
2.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Mouth: Screening
|
9.9 percentage of participants
|
2.9 percentage of participants
|
5.7 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Mouth: EOS
|
7.1 percentage of participants
|
2.9 percentage of participants
|
5.8 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Musculoskeletal: Screening
|
31.0 percentage of participants
|
38.2 percentage of participants
|
35.7 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Musculoskeletal: EOS
|
33.8 percentage of participants
|
38.2 percentage of participants
|
37.7 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Nose: Screening
|
0 percentage of participants
|
2.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Nose: EOS
|
0 percentage of participants
|
0 percentage of participants
|
5.8 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Skin: Screening
|
9.9 percentage of participants
|
14.7 percentage of participants
|
21.4 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Skin: EOS
|
8.5 percentage of participants
|
14.7 percentage of participants
|
21.7 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Throat: Screening
|
1.4 percentage of participants
|
2.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Throat: EOS
|
0 percentage of participants
|
5.9 percentage of participants
|
2.9 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Pregabalin 7 mg/kg/Day or 6 mg/kg/Day
n=71 Participants
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.
|
Pregabalin 14 mg/kg/Day or 12 mg/kg/Day
n=34 Participants
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.
|
Placebo
n=70 Participants
Participants aged \>3 months to \<4 years received placebo matched to Pregabalin, orally TID for 21 days.
|
|---|---|---|---|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - right triceps (BL)
|
45.1 percentage of participants
|
58.8 percentage of participants
|
48.6 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - right knee (BL)
|
52.1 percentage of participants
|
61.8 percentage of participants
|
61.4 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - right knee (EOS)
|
50.7 percentage of participants
|
64.7 percentage of participants
|
59.4 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - left triceps (BL)
|
46.5 percentage of participants
|
52.9 percentage of participants
|
45.7 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - left triceps (EOS)
|
46.5 percentage of participants
|
52.9 percentage of participants
|
44.9 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - right triceps (EOS)
|
45.1 percentage of participants
|
58.8 percentage of participants
|
47.8 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Speech - articulation (BL)
|
53.5 percentage of participants
|
47.1 percentage of participants
|
45.7 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Speech - articulation (EOS)
|
54.9 percentage of participants
|
44.1 percentage of participants
|
47.8 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Speech - language (BL)
|
69.0 percentage of participants
|
76.5 percentage of participants
|
65.7 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Speech - language (EOS)
|
69.0 percentage of participants
|
73.5 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Coordination- left hand movement (BL)
|
1.4 percentage of participants
|
11.8 percentage of participants
|
8.6 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Coordination-left hand movement (EOS)
|
1.4 percentage of participants
|
8.8 percentage of participants
|
10.1 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Coordination- right hand movement (EOS)
|
2.8 percentage of participants
|
5.9 percentage of participants
|
10.1 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
CNF: left fundoscopic exam (EOS)
|
12.7 percentage of participants
|
23.5 percentage of participants
|
14.5 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Coordination- romberg test (BL)
|
2.8 percentage of participants
|
8.8 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Coordination- romberg test (EOS)
|
2.8 percentage of participants
|
5.9 percentage of participants
|
11.6 percentage of participants
|
|
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
|
8.8 percentage of participants
|
10.0 percentage of participants
|
|
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
|
8.8 percentage of participants
|
10.1 percentage of participants
|
|
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
|
5.9 percentage of participants
|
10.0 percentage of participants
|
|
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
|
5.9 percentage of participants
|
10.1 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
CNF: left fundoscopic exam (BL)
|
12.7 percentage of participants
|
26.5 percentage of participants
|
12.9 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
CNF: right fundoscopic exam (BL)
|
11.3 percentage of participants
|
20.6 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
CNF: right fundoscopic exam (EOS)
|
11.3 percentage of participants
|
17.6 percentage of participants
|
14.5 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
CNF: left visual acuity (BL)
|
11.3 percentage of participants
|
11.8 percentage of participants
|
12.9 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
CNF: left visual acuity (EOS)
|
11.3 percentage of participants
|
11.8 percentage of participants
|
13.0 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
CNF: right visual acuity (BL)
|
11.3 percentage of participants
|
11.8 percentage of participants
|
11.4 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
CNF: right visual acuity (EOS)
|
11.3 percentage of participants
|
11.8 percentage of participants
|
11.6 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
CNF: finger tracking (BL)
|
22.5 percentage of participants
|
26.5 percentage of participants
|
24.3 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
CNF: finger tracking (EOS)
|
21.1 percentage of participants
|
23.5 percentage of participants
|
26.1 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
CNF: swallowing (BL)
|
14.1 percentage of participants
|
14.7 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
CNF: swallowing (EOS)
|
14.1 percentage of participants
|
14.7 percentage of participants
|
14.5 percentage of participants
|
|
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
|
2.9 percentage of participants
|
7.1 percentage of participants
|
|
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
|
2.9 percentage of participants
|
10.1 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Gait and station - gait (BL)
|
52.1 percentage of participants
|
50.0 percentage of participants
|
45.7 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Gait and station - gait (EOS)
|
52.1 percentage of participants
|
52.9 percentage of participants
|
46.4 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Level of consciousness (BL)
|
5.6 percentage of participants
|
20.6 percentage of participants
|
5.7 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Level of consciousness (EOS)
|
7.0 percentage of participants
|
20.6 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Muscle strength -lower extremities (BL)
|
49.3 percentage of participants
|
58.8 percentage of participants
|
51.4 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Muscle strength -lower extremities (EOS)
|
49.3 percentage of participants
|
58.8 percentage of participants
|
53.6 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Muscle strength - upper extremities (BL)
|
47.9 percentage of participants
|
58.8 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Muscle strength - upper extremities (EOS)
|
49.3 percentage of participants
|
58.8 percentage of participants
|
52.2 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Muscle strength - trunk (BL)
|
43.7 percentage of participants
|
38.2 percentage of participants
|
44.3 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Muscle strength - trunk (EOS)
|
39.4 percentage of participants
|
38.2 percentage of participants
|
42.0 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Muscle tone - lower extremities (BL)
|
64.3 percentage of participants
|
73.5 percentage of participants
|
63.8 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Muscle tone - lower extremities (EOS)
|
64.8 percentage of participants
|
73.5 percentage of participants
|
66.2 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Muscle tone - upper extremities (BL)
|
64.8 percentage of participants
|
73.5 percentage of participants
|
63.8 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Muscle tone - upper extremities (EOS)
|
64.8 percentage of participants
|
73.5 percentage of participants
|
66.2 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Nystagmus - horizontal (BL)
|
9.9 percentage of participants
|
11.8 percentage of participants
|
7.1 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Nystagmus - horizontal (EOS)
|
8.5 percentage of participants
|
11.8 percentage of participants
|
5.8 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - left ankle (BL)
|
46.5 percentage of participants
|
52.9 percentage of participants
|
47.1 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - left ankle (EOS)
|
46.5 percentage of participants
|
52.9 percentage of participants
|
46.4 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - right ankle (BL)
|
46.5 percentage of participants
|
58.8 percentage of participants
|
47.1 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - right ankle (EOS)
|
45.1 percentage of participants
|
58.8 percentage of participants
|
46.4 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - left babinski (BL)
|
42.3 percentage of participants
|
47.1 percentage of participants
|
47.1 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - left babinski (EOS)
|
40.8 percentage of participants
|
47.1 percentage of participants
|
47.8 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - right babinski (BL)
|
42.3 percentage of participants
|
55.9 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - right babinski (EOS)
|
40.8 percentage of participants
|
55.9 percentage of participants
|
50.7 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - left biceps (BL)
|
47.9 percentage of participants
|
52.9 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - left biceps (EOS)
|
47.9 percentage of participants
|
52.9 percentage of participants
|
49.3 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - right biceps (BL)
|
46.5 percentage of participants
|
58.8 percentage of participants
|
52.9 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - right biceps (EOS)
|
46.5 percentage of participants
|
58.8 percentage of participants
|
52.2 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - left brachioradialis (BL)
|
45.1 percentage of participants
|
52.9 percentage of participants
|
48.6 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - left brachioradialis (EOS)
|
45.1 percentage of participants
|
52.9 percentage of participants
|
47.8 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - right brachioradialis (BL)
|
43.7 percentage of participants
|
58.8 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - right brachioradialis (EOS)
|
43.7 percentage of participants
|
58.8 percentage of participants
|
50.7 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - left knee (BL)
|
53.5 percentage of participants
|
55.9 percentage of participants
|
57.1 percentage of participants
|
|
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Reflexes - left knee (EOS)
|
52.1 percentage of participants
|
58.8 percentage of participants
|
56.5 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From screening up to EOS (maximum Day 25)Population: Safety population included all randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Pregabalin 7 mg/kg/Day or 6 mg/kg/Day
n=71 Participants
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.
|
Pregabalin 14 mg/kg/Day or 12 mg/kg/Day
n=34 Participants
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.
|
Placebo
n=70 Participants
Participants aged \>3 months to \<4 years received placebo matched to Pregabalin, orally TID for 21 days.
|
|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities
|
0 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
Pregabalin 7 mg/kg/Day or 6 mg/kg/Day
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Pregabalin 14 mg/kg/Day or 12 mg/kg/Day
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregabalin 7 mg/kg/Day or 6 mg/kg/Day
n=71 participants at risk
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.
|
Pregabalin 14 mg/kg/Day or 12 mg/kg/Day
n=34 participants at risk
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.
|
Placebo
n=70 participants at risk
Participants aged \>3 months to \<4 years received placebo matched to Pregabalin, orally TID for 21 days.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
2.9%
1/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Nervous system disorders
Seizure
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
Other adverse events
| Measure |
Pregabalin 7 mg/kg/Day or 6 mg/kg/Day
n=71 participants at risk
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.
|
Pregabalin 14 mg/kg/Day or 12 mg/kg/Day
n=34 participants at risk
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.
|
Placebo
n=70 participants at risk
Participants aged \>3 months to \<4 years received placebo matched to Pregabalin, orally TID for 21 days.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
2.9%
1/34 • Day 1 up to End of Study (maximum Day 25)
|
2.9%
2/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Eye disorders
Chalazion
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Eye disorders
Mydriasis
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
2.9%
1/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
3/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Gastrointestinal disorders
Dry mouth
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Gastrointestinal disorders
Oral contusion
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
2.9%
1/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
8.6%
6/70 • Day 1 up to End of Study (maximum Day 25)
|
|
General disorders
Application site irritation
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
2.9%
1/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
General disorders
Asthenia
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
General disorders
Hyperthermia
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
2.9%
1/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
General disorders
Pyrexia
|
5.6%
4/71 • Day 1 up to End of Study (maximum Day 25)
|
5.9%
2/34 • Day 1 up to End of Study (maximum Day 25)
|
5.7%
4/70 • Day 1 up to End of Study (maximum Day 25)
|
|
General disorders
Sluggishness
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
General disorders
Feeling hot
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
2.9%
1/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
2.9%
1/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
2.9%
1/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Infections and infestations
Ear infection
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Infections and infestations
Fungal infection
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Infections and infestations
Impetigo
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Infections and infestations
Lice infestation
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
5.9%
2/34 • Day 1 up to End of Study (maximum Day 25)
|
4.3%
3/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Infections and infestations
Otitis media
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
2.9%
1/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Infections and infestations
Pneumonia
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
5.9%
2/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Infections and infestations
Respiratory tract infection viral
|
2.8%
2/71 • Day 1 up to End of Study (maximum Day 25)
|
2.9%
1/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Infections and infestations
Tracheitis
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
2.9%
1/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Infections and infestations
Upper respiratory tract infection
|
7.0%
5/71 • Day 1 up to End of Study (maximum Day 25)
|
11.8%
4/34 • Day 1 up to End of Study (maximum Day 25)
|
11.4%
8/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
2.9%
2/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Infections and infestations
Viral infection
|
2.8%
2/71 • Day 1 up to End of Study (maximum Day 25)
|
5.9%
2/34 • Day 1 up to End of Study (maximum Day 25)
|
2.9%
2/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Infections and infestations
Viral rash
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Injury, poisoning and procedural complications
Contusion
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Injury, poisoning and procedural complications
Fall
|
2.8%
2/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
2.9%
2/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
2.9%
1/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Investigations
Electrocardiogram repolarisation abnormality
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Investigations
Haemoglobin decreased
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Investigations
Lymphocyte morphology abnormal
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Investigations
Lymphocyte percentage increased
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Investigations
Neutrophil percentage decreased
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Investigations
Platelet count decreased
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Investigations
Platelet count increased
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
4.3%
3/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Metabolism and nutrition disorders
Increased appetite
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Nervous system disorders
Balance disorder
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Nervous system disorders
Dysarthria
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
2.9%
1/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Nervous system disorders
Lethargy
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Nervous system disorders
Myoclonic epilepsy
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
2.9%
1/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Nervous system disorders
Seizure
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
5.9%
2/34 • Day 1 up to End of Study (maximum Day 25)
|
4.3%
3/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Nervous system disorders
Somnolence
|
11.3%
8/71 • Day 1 up to End of Study (maximum Day 25)
|
17.6%
6/34 • Day 1 up to End of Study (maximum Day 25)
|
5.7%
4/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Psychiatric disorders
Agitation
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Psychiatric disorders
Enuresis
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Psychiatric disorders
Irritability
|
4.2%
3/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Psychiatric disorders
Sleep disorder
|
2.8%
2/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
2.9%
1/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
4.3%
3/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.8%
2/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
4.3%
3/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
1.4%
1/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
2.9%
2/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
4.3%
3/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/70 • Day 1 up to End of Study (maximum Day 25)
|
|
Vascular disorders
Haematoma
|
1.4%
1/71 • Day 1 up to End of Study (maximum Day 25)
|
0.00%
0/34 • Day 1 up to End of Study (maximum Day 25)
|
2.9%
2/70 • Day 1 up to End of Study (maximum Day 25)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER