Trial Outcomes & Findings for Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan) (NCT NCT01441401)
NCT ID: NCT01441401
Last Updated: 2021-02-03
Results Overview
A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Recruitment status
COMPLETED
Target enrollment
82 participants
Primary outcome timeframe
MAX 104 weeks
Results posted on
2021-02-03
Participant Flow
Participant milestones
| Measure |
Gabapentin Tablets/Syrup
For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
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|---|---|
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Overall Study
STARTED
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82
|
|
Overall Study
COMPLETED
|
82
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)
Baseline characteristics by cohort
| Measure |
Gabapentin Tablets/Syrup
n=82 Participants
For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
|
|---|---|
|
Age, Customized
3 to 4 years
|
14 Participants
n=5 Participants
|
|
Age, Customized
5 to 12 years
|
54 Participants
n=5 Participants
|
|
Age, Customized
13 to 15 years
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: MAX 104 weeksPopulation: The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.
A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Outcome measures
| Measure |
Gabapentin Tablets/Syrup
n=82 Participants
For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
|
Moderate
Participants with moderate epileptic seizure at baseline
|
Severe
Participants with severe epileptic seizure at baseline
|
Unknown
Participants with unknown severity of baseline epileptic seizure
|
Four or More Concomitant Antiepileptic Drugs
Participants taking four or more concomitant antiepileptic drugs at baseline
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Related Adverse Events
|
5 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: MAX 104 weeksPopulation: The analysis population comprised of the participants in the efficacy analysis population from which those with data not assessable were excluded. n=number of participants with assessable data at each post-baseline time point.
Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical efficacy over the total number of efficacy analysis population, was presented along with the corresponding exact 2-sided 95% CI. For the basis of efficacy evaluation, frequencies of epileptic seizure were recorded during the previous 4 weeks from the treatment start date, and that from the end date of assessment period. Clinical efficacy was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable.
Outcome measures
| Measure |
Gabapentin Tablets/Syrup
n=75 Participants
For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
|
Moderate
Participants with moderate epileptic seizure at baseline
|
Severe
Participants with severe epileptic seizure at baseline
|
Unknown
Participants with unknown severity of baseline epileptic seizure
|
Four or More Concomitant Antiepileptic Drugs
Participants taking four or more concomitant antiepileptic drugs at baseline
|
|---|---|---|---|---|---|
|
Clinical Efficacy Rate
Week 12 (n = 73)
|
56.2 Percentage of participants
Interval 44.1 to 67.8
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—
|
—
|
—
|
—
|
|
Clinical Efficacy Rate
Week 52 (n = 52)
|
57.7 Percentage of participants
Interval 43.2 to 71.3
|
—
|
—
|
—
|
—
|
|
Clinical Efficacy Rate
Week 104 (n = 14)
|
64.3 Percentage of participants
Interval 35.1 to 87.2
|
—
|
—
|
—
|
—
|
|
Clinical Efficacy Rate
End of assessment period (n = 66)
|
42.4 Percentage of participants
Interval 30.3 to 55.2
|
—
|
—
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—
|
—
|
SECONDARY outcome
Timeframe: MAX 104 weeksPopulation: The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.
A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to gabapentin was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Outcome measures
| Measure |
Gabapentin Tablets/Syrup
n=82 Participants
For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
|
Moderate
Participants with moderate epileptic seizure at baseline
|
Severe
Participants with severe epileptic seizure at baseline
|
Unknown
Participants with unknown severity of baseline epileptic seizure
|
Four or More Concomitant Antiepileptic Drugs
Participants taking four or more concomitant antiepileptic drugs at baseline
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
|
0 Participants
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—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: MAX 104 weeksPopulation: The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once. No data displayed because outcome measure has zero total participants analyzed.
A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Participants with treatment-related adverse events were counted by each candidate risk factor (including gender, age, and disease eligible for the survey) to assess whether these were risk factors for the treatment-related adverse events. No inferential analyses of risk factors were performed because of a small number of the events (5 events).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: MAX 104 weeksPopulation: The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants with diseases not eligible for the survey were excluded from the efficacy analysis population.
Participants who responded to the treatment with gabapentin were counted by the baseline severity of epileptic seizure (mild, moderate and severe) to assess whether the baseline severity of epileptic seizure was a factor affecting the treatment efficacy.
Outcome measures
| Measure |
Gabapentin Tablets/Syrup
n=9 Participants
For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
|
Moderate
n=31 Participants
Participants with moderate epileptic seizure at baseline
|
Severe
n=25 Participants
Participants with severe epileptic seizure at baseline
|
Unknown
n=1 Participants
Participants with unknown severity of baseline epileptic seizure
|
Four or More Concomitant Antiepileptic Drugs
Participants taking four or more concomitant antiepileptic drugs at baseline
|
|---|---|---|---|---|---|
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Number of Participants Who Responded to Treatment With Gabapentin by Baseline Severity of Epileptic Seizure
|
6 Participants
|
15 Participants
|
6 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: MAX 104 weeksPopulation: The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants with diseases not eligible for the survey were excluded from the efficacy analysis population.
Participants who responded to the treatment with gabapentin were counted by the baseline frequency of epileptic seizure (\<=8 versus \>8 episodes/per 4 weeks) to assess whether the baseline frequency of epileptic seizure was a factor affecting the treatment efficacy.
Outcome measures
| Measure |
Gabapentin Tablets/Syrup
n=25 Participants
For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
|
Moderate
n=39 Participants
Participants with moderate epileptic seizure at baseline
|
Severe
n=2 Participants
Participants with severe epileptic seizure at baseline
|
Unknown
Participants with unknown severity of baseline epileptic seizure
|
Four or More Concomitant Antiepileptic Drugs
Participants taking four or more concomitant antiepileptic drugs at baseline
|
|---|---|---|---|---|---|
|
Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure
|
15 Participants
|
11 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: MAX 104 weeksPopulation: The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants with diseases not eligible for the survey were excluded from the efficacy analysis population.
Participants who responded to the treatment with gabapentin were counted by the number of concomitant epileptic drugs at baseline across 5 categories (no drug, 1 drug, 2 drugs, 3 drugs, and 4 or more drugs) to assess whether the number of concomitant epileptic drugs at baseline was a factor affecting the treatment efficacy.
Outcome measures
| Measure |
Gabapentin Tablets/Syrup
n=1 Participants
For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
|
Moderate
n=19 Participants
Participants with moderate epileptic seizure at baseline
|
Severe
n=19 Participants
Participants with severe epileptic seizure at baseline
|
Unknown
n=15 Participants
Participants with unknown severity of baseline epileptic seizure
|
Four or More Concomitant Antiepileptic Drugs
n=12 Participants
Participants taking four or more concomitant antiepileptic drugs at baseline
|
|---|---|---|---|---|---|
|
Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline
|
1 Participants
|
13 Participants
|
7 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: MAX 104 weeksPopulation: The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants with diseases not eligible for the survey were excluded from the efficacy analysis population.
Participants who responded to the treatment with gabapentin were counted by the treatment period (non-long term \[less than 1 year\] or long term \[1 year or more\]) to assess whether the treatment period with gabapentin was a factor affecting the treatment efficacy.
Outcome measures
| Measure |
Gabapentin Tablets/Syrup
n=19 Participants
For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
|
Moderate
n=47 Participants
Participants with moderate epileptic seizure at baseline
|
Severe
Participants with severe epileptic seizure at baseline
|
Unknown
Participants with unknown severity of baseline epileptic seizure
|
Four or More Concomitant Antiepileptic Drugs
Participants taking four or more concomitant antiepileptic drugs at baseline
|
|---|---|---|---|---|---|
|
Number of Participants Who Responded to Treatment With Gabapentin by Treatment Period
|
2 Participants
|
26 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: MAX 104 weeksPopulation: The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.
Central nervous system depressant actions including somnolence and ataxia were determined as key survey items by the sponsor (Pfizer Japan Inc.). These events were defined according to MedDRA/J version 17.1 as the events classified in "psychiatric disorders" or "nervous system disorders" of the system organ classes, or those classified in "asthenia" or "gait disturbance" of the preferred terms. A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the investigator and sponsor.
Outcome measures
| Measure |
Gabapentin Tablets/Syrup
n=82 Participants
For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
|
Moderate
Participants with moderate epileptic seizure at baseline
|
Severe
Participants with severe epileptic seizure at baseline
|
Unknown
Participants with unknown severity of baseline epileptic seizure
|
Four or More Concomitant Antiepileptic Drugs
Participants taking four or more concomitant antiepileptic drugs at baseline
|
|---|---|---|---|---|---|
|
Number of Participants With Key Treatment-Related Adverse Events (Central Nervous System Depressant Actions)
|
1 Participants
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: MAX 104 weeksPopulation: The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.
Aggressive behaviors including affect lability and hostility were determined as key survey items by the sponsor (Pfizer Japan Inc.). These events were defined as the 101 preferred terms listed by pharmaceuticals and medical devices agency and classified according to MedDRA/J version 17.1. A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the investigator and sponsor.
Outcome measures
| Measure |
Gabapentin Tablets/Syrup
n=82 Participants
For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
|
Moderate
Participants with moderate epileptic seizure at baseline
|
Severe
Participants with severe epileptic seizure at baseline
|
Unknown
Participants with unknown severity of baseline epileptic seizure
|
Four or More Concomitant Antiepileptic Drugs
Participants taking four or more concomitant antiepileptic drugs at baseline
|
|---|---|---|---|---|---|
|
Number of Participants With Key Treatment-Related Adverse Events (Aggressive Behaviors)
|
1 Participants
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: MAX 104 weeksPopulation: The analysis population comprised of the participants in the efficacy analysis population who had assessable data of the frequency of epileptic seizures at the start of gabapentin treatment and at the end of assessment period. n=number of participants with assessable data at each post-baseline time point.
R Ratio was calculated by the following formula, where B represented the baseline frequency of epileptic seizures during the previous 4 weeks from the treatment start date, whereas T represented the frequency of epileptic seizures during the previous 4 weeks from the end of assessment period: R Ratio = (T - B) / (T + B). R Ratio is within the range of -1 to +1, and a negative value represents a reduction in the frequency of seizure.
Outcome measures
| Measure |
Gabapentin Tablets/Syrup
n=73 Participants
For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
|
Moderate
Participants with moderate epileptic seizure at baseline
|
Severe
Participants with severe epileptic seizure at baseline
|
Unknown
Participants with unknown severity of baseline epileptic seizure
|
Four or More Concomitant Antiepileptic Drugs
Participants taking four or more concomitant antiepileptic drugs at baseline
|
|---|---|---|---|---|---|
|
Response Ratio (R Ratio)
Week 12 (n = 72)
|
-0.332 Ratio
Standard Deviation 0.458 • Interval 44.1 to 67.8
|
—
|
—
|
—
|
—
|
|
Response Ratio (R Ratio)
Week 52 (n = 56)
|
-0.409 Ratio
Standard Deviation 0.491 • Interval 43.2 to 71.3
|
—
|
—
|
—
|
—
|
|
Response Ratio (R Ratio)
Week 104 (n = 16)
|
-0.456 Ratio
Standard Deviation 0.507 • Interval 35.1 to 87.2
|
—
|
—
|
—
|
—
|
|
Response Ratio (R Ratio)
End of assessment period (n = 73)
|
-0.369 Ratio
Standard Deviation 0.509 • Interval 30.3 to 55.2
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: MAX 104 weeksPopulation: The analysis population comprised of the participants in the efficacy analysis population who had assessable data of the frequency of epileptic seizures at the start of gabapentin treatment and at the end of assessment period. n=number of participants with assessable data at each post-baseline time point.
Responder rate, which was defined as the percentage of participants whose R ratio was - 0.333 or less, was presented along with the corresponding exact 2-sided 95% CI. R ratio of - 0.333 or less corresponded to the decrease of epileptic seizure frequency by 50% or more.
Outcome measures
| Measure |
Gabapentin Tablets/Syrup
n=73 Participants
For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
|
Moderate
Participants with moderate epileptic seizure at baseline
|
Severe
Participants with severe epileptic seizure at baseline
|
Unknown
Participants with unknown severity of baseline epileptic seizure
|
Four or More Concomitant Antiepileptic Drugs
Participants taking four or more concomitant antiepileptic drugs at baseline
|
|---|---|---|---|---|---|
|
Responder Rate
Week 12 (n = 72)
|
43.1 Percentage of participants
Interval 31.4 to 55.3
|
—
|
—
|
—
|
—
|
|
Responder Rate
Week 52 (n = 56)
|
50.0 Percentage of participants
Interval 36.3 to 63.7
|
—
|
—
|
—
|
—
|
|
Responder Rate
Week 104 (n = 16)
|
62.5 Percentage of participants
Interval 35.4 to 84.8
|
—
|
—
|
—
|
—
|
|
Responder Rate
End of assessment period (n = 73)
|
49.3 Percentage of participants
Interval 37.4 to 61.3
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: MAX 104 weeksPopulation: The analysis population comprised of the participants in the efficacy analysis population who had assessable data of the frequency of epileptic seizures at the start of gabapentin treatment and at the end of assessment period. n=number of participants with assessable data at each post-baseline time point.
Reduction from baseline in epileptic seizure frequency was defined by the following formula, where B represented the baseline frequency of epileptic seizures during the previous 4 weeks from the treatment start date, whereas T represented the frequency of epileptic seizures during the previous 4 weeks from the end of assessment period: Reduction from baseline in epileptic seizure frequency (%) = \[(T-B) / B\] X 100. The median percentages were presented along with the corresponding minimum and maximum percentages.
Outcome measures
| Measure |
Gabapentin Tablets/Syrup
n=73 Participants
For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
|
Moderate
Participants with moderate epileptic seizure at baseline
|
Severe
Participants with severe epileptic seizure at baseline
|
Unknown
Participants with unknown severity of baseline epileptic seizure
|
Four or More Concomitant Antiepileptic Drugs
Participants taking four or more concomitant antiepileptic drugs at baseline
|
|---|---|---|---|---|---|
|
Reduction From Baseline in Epileptic Seizure Frequency
Week 12 (n = 72)
|
-25.0 Percentage
Interval -100.0 to 900.0
|
—
|
—
|
—
|
—
|
|
Reduction From Baseline in Epileptic Seizure Frequency
Week 52 (n = 56)
|
-49.0 Percentage
Interval -100.0 to 833.3
|
—
|
—
|
—
|
—
|
|
Reduction From Baseline in Epileptic Seizure Frequency
Week 104 (n = 16)
|
-60.0 Percentage
Interval -100.0 to 1090.5
|
—
|
—
|
—
|
—
|
|
Reduction From Baseline in Epileptic Seizure Frequency
End of assessment period (n = 73)
|
-47.9 Percentage
Interval -100.0 to 1090.5
|
—
|
—
|
—
|
—
|
Adverse Events
Gabapentin Tablets/Syrup
Serious events: 4 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gabapentin Tablets/Syrup
n=82 participants at risk
For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
|
|---|---|
|
Infections and infestations
Bronchitis
|
2.4%
2/82 • Number of events 2
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Febrile convulsion
|
1.2%
1/82 • Number of events 1
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.2%
1/82 • Number of events 1
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Gabapentin Tablets/Syrup
n=82 participants at risk
For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
|
|---|---|
|
Infections and infestations
Influenza
|
1.2%
1/82 • Number of events 1
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
3.7%
3/82 • Number of events 3
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pharyngitis
|
1.2%
1/82 • Number of events 1
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
4.9%
4/82 • Number of events 4
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes zoster
|
1.2%
1/82 • Number of events 1
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Paronychia
|
1.2%
1/82 • Number of events 1
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
14.6%
12/82 • Number of events 12
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Rhinitis
|
2.4%
2/82 • Number of events 2
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
1.2%
1/82 • Number of events 1
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
1.2%
1/82 • Number of events 1
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Dissociative disorder
|
1.2%
1/82 • Number of events 1
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Affect lability
|
1.2%
1/82 • Number of events 1
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
1.2%
1/82 • Number of events 1
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Convulsion
|
1.2%
1/82 • Number of events 1
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.2%
1/82 • Number of events 1
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
3.7%
3/82 • Number of events 3
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
1.2%
1/82 • Number of events 1
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
1.2%
1/82 • Number of events 1
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.2%
1/82 • Number of events 1
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/82 • Number of events 1
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
2.4%
2/82 • Number of events 2
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/82 • Number of events 1
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.2%
1/82 • Number of events 1
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
1.2%
1/82 • Number of events 1
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.4%
2/82 • Number of events 2
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
1/82 • Number of events 1
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.4%
2/82 • Number of events 2
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Urinary incontinence
|
1.2%
1/82 • Number of events 1
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Hepatic enzyme increased
|
1.2%
1/82 • Number of events 1
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
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