Trial Outcomes & Findings for Comparative Study Of Pregabalin And Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures (NCT NCT00537940)
NCT ID: NCT00537940
Last Updated: 2021-01-22
Results Overview
The seizures were recorded by the participants, by a family member, by a caregiver, or by a legal guardian and documented in a daily seizure diary. Participant's 28-day seizure frequency of all partial seizure was assessed during double blind (TP + MP) phase compared with baseline. Total partial seizure is defined as the total number of (simple partial seizure + complex partial seizure + secondary generalized tonic clonic seizure \[SGTC\]).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
482 participants
Primary outcome timeframe
6 weeks Baseline, 21 weeks through End of MP for 27 weeks
Results posted on
2021-01-22
Participant Flow
Overall, 561 participants were screened and 482 participants participated in the study; 242 participants were randomized but one participant from the pregabalin group and one participant from the gabapentin group were not treated. Hence 241 participants were treated in each treatment group. Participants were randomized at 56 centers.
One participant from the pregabalin group and one participant from the gabapentin group were randomized but not treated.
Participant milestones
| Measure |
Pregabalin
Pregabalin was initiated at 150 mg/day \[50 mg capsules orally three times a day (TID)\] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: \>=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
|
Gabapentin
Gabapentin was initiated at 300 mg/day \[100 mg capsules orally three times a day (TID)\] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (\>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
|
|---|---|---|
|
Overall Study
STARTED
|
241
|
241
|
|
Overall Study
Completed Titration Phase
|
213
|
210
|
|
Overall Study
Completed Maintenance Phase
|
187
|
172
|
|
Overall Study
Entered Opt Blinded Continuation Phase
|
140
|
139
|
|
Overall Study
COMPLETED
|
58
|
62
|
|
Overall Study
NOT COMPLETED
|
183
|
179
|
Reasons for withdrawal
| Measure |
Pregabalin
Pregabalin was initiated at 150 mg/day \[50 mg capsules orally three times a day (TID)\] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: \>=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
|
Gabapentin
Gabapentin was initiated at 300 mg/day \[100 mg capsules orally three times a day (TID)\] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (\>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
|
|---|---|---|
|
Overall Study
Adverse Event
|
20
|
19
|
|
Overall Study
Lack of Efficacy
|
8
|
16
|
|
Overall Study
Lost to Follow-up
|
23
|
29
|
|
Overall Study
Withdrawal by Subject
|
113
|
95
|
|
Overall Study
Protocol Violation
|
6
|
4
|
|
Overall Study
Pregnancy
|
1
|
1
|
|
Overall Study
Study terminated by sponsor
|
2
|
3
|
|
Overall Study
Other
|
10
|
12
|
Baseline Characteristics
Comparative Study Of Pregabalin And Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures
Baseline characteristics by cohort
| Measure |
Pregabalin
n=241 Participants
Pregabalin was initiated at 150 mg/day \[50 mg capsules orally three times a day (TID)\] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: \>=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
|
Gabapentin
n=241 Participants
Gabapentin was initiated at 300 mg/day \[100 mg capsules orally three times a day (TID)\] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (\>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
|
Total
n=482 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.9 years
STANDARD_DEVIATION 13.0 • n=93 Participants
|
35.3 years
STANDARD_DEVIATION 12.9 • n=4 Participants
|
35.1 years
STANDARD_DEVIATION 13.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=93 Participants
|
111 Participants
n=4 Participants
|
225 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=93 Participants
|
130 Participants
n=4 Participants
|
257 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 weeks Baseline, 21 weeks through End of MP for 27 weeksPopulation: Full analysis set (FAS) included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation.
The seizures were recorded by the participants, by a family member, by a caregiver, or by a legal guardian and documented in a daily seizure diary. Participant's 28-day seizure frequency of all partial seizure was assessed during double blind (TP + MP) phase compared with baseline. Total partial seizure is defined as the total number of (simple partial seizure + complex partial seizure + secondary generalized tonic clonic seizure \[SGTC\]).
Outcome measures
| Measure |
Pregabalin
n=238 Participants
Pregabalin was initiated at 150 mg/day \[50 mg capsules orally three times a day (TID)\] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: \>=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
|
Gabapentin
n=240 Participants
Gabapentin was initiated at 300 mg/day \[100 mg capsules orally three times a day (TID)\] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (\>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
|
|---|---|---|
|
Percent Change From Baseline in 28-day Seizure Frequency at Week 21.
|
-58.65 percent change
Interval -100.0 to 180.0
|
-57.43 percent change
Interval -100.0 to 392.4
|
SECONDARY outcome
Timeframe: 6 weeks Baseline, 21 weeks through End of MP for 27 weeksPopulation: FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 Baseline and post Baseline primary efficacy evaluation. n=is the number of subjects that can be analyzed for each treatment group.
Participants who had at least 50% reduction in seizure frequency from Baseline to double-blind treatment (TP + MP) were considered as 50% responders. If percent change from baseline \<= -50 then responder rate = 1 (yes) otherwise responder rate = 0 (no).
Outcome measures
| Measure |
Pregabalin
n=238 Participants
Pregabalin was initiated at 150 mg/day \[50 mg capsules orally three times a day (TID)\] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: \>=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
|
Gabapentin
n=240 Participants
Gabapentin was initiated at 300 mg/day \[100 mg capsules orally three times a day (TID)\] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (\>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
|
|---|---|---|
|
Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21.
All Partial Seizure (n=238, 240)
|
56.3 Percentage of participants
Interval 50.0 to 62.6
|
58.3 Percentage of participants
Interval 52.1 to 64.6
|
|
Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21.
Simple Partial (n=87, 88)
|
55.2 Percentage of participants
Interval 44.7 to 65.6
|
53.4 Percentage of participants
Interval 43.0 to 63.8
|
|
Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21.
Complex Partial (n=161, 158)
|
56.5 Percentage of participants
Interval 48.9 to 64.2
|
55.1 Percentage of participants
Interval 47.3 to 62.8
|
|
Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21.
SGTC (n=112, 114)
|
50.9 Percentage of participants
Interval 41.6 to 60.2
|
60.5 Percentage of participants
Interval 51.6 to 69.5
|
SECONDARY outcome
Timeframe: 6 weeks Baseline, 21 weeks through End of MP for 27 weeksPopulation: FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 Baseline and post Baseline primary efficacy evaluation. n=is the number of participants that can be analyzed for each treatment group.
Participants who had at least 75% reduction in seizure frequency from Baseline to double-blind treatment (TP + MP) were considered as 75% responders. If percent change from baseline \<= -75 then 75% responder rate = 1 (yes) otherwise responder rate = 0 (no). Total partial seizure is defined as the total number of (simple partial seizure + complex partial seizure + SGTC).
Outcome measures
| Measure |
Pregabalin
n=238 Participants
Pregabalin was initiated at 150 mg/day \[50 mg capsules orally three times a day (TID)\] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: \>=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
|
Gabapentin
n=240 Participants
Gabapentin was initiated at 300 mg/day \[100 mg capsules orally three times a day (TID)\] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (\>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
|
|---|---|---|
|
Percentage of Participants With 75% Reduction From Baseline in 28-day Seizure Rate at Week 21.
All Partial Seizure (n=238, 240)
|
33.6 Percentage of participants
Interval 27.6 to 39.6
|
34.2 Percentage of participants
Interval 28.2 to 40.2
|
|
Percentage of Participants With 75% Reduction From Baseline in 28-day Seizure Rate at Week 21.
Simple Partial (n=87, 88)
|
36.8 Percentage of participants
Interval 26.7 to 46.9
|
33.0 Percentage of participants
Interval 23.1 to 42.8
|
|
Percentage of Participants With 75% Reduction From Baseline in 28-day Seizure Rate at Week 21.
Complex Partial (n=161, 158)
|
37.3 Percentage of participants
Interval 29.8 to 44.7
|
36.1 Percentage of participants
Interval 28.6 to 43.6
|
|
Percentage of Participants With 75% Reduction From Baseline in 28-day Seizure Rate at Week 21.
SGTC (n=112, 114)
|
38.4 Percentage of participants
Interval 29.4 to 47.4
|
43.9 Percentage of participants
Interval 34.8 to 53.0
|
SECONDARY outcome
Timeframe: 6 weeks Baseline, 21 weeks through End of MP for 27 weeksPopulation: FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 Baseline and post Baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure.
Seizure free for 28 days was defined as participants who have not experienced any seizure (simple partial, complex partial and SGTC) for at least 28 consecutive days from their last seizure until the end of the MP. Same participant could be seizure free for a specific type of seizure but not necessarily for the other types of seizure.
Outcome measures
| Measure |
Pregabalin
n=189 Participants
Pregabalin was initiated at 150 mg/day \[50 mg capsules orally three times a day (TID)\] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: \>=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
|
Gabapentin
n=182 Participants
Gabapentin was initiated at 300 mg/day \[100 mg capsules orally three times a day (TID)\] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (\>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
|
|---|---|---|
|
Percentage of Participants Without Seizures.
All Partial Seizure (n=189, 182)
|
30.7 percentage of participants
Interval 24.1 to 37.3
|
34.1 percentage of participants
Interval 27.2 to 41.0
|
|
Percentage of Participants Without Seizures.
Simple Partial (n=74, 66)
|
29.7 percentage of participants
Interval 19.3 to 40.1
|
36.4 percentage of participants
Interval 24.8 to 48.0
|
|
Percentage of Participants Without Seizures.
Complex Partial (n=126, 123)
|
37.3 percentage of participants
Interval 28.9 to 45.8
|
40.7 percentage of participants
Interval 32.0 to 49.3
|
|
Percentage of Participants Without Seizures.
SGTC (n=95, 91)
|
46.3 percentage of participants
Interval 36.3 to 56.3
|
42.9 percentage of participants
Interval 32.7 to 53.0
|
SECONDARY outcome
Timeframe: 6 weeks Baseline, 21 weeks through End of MP for 27 weeksPopulation: SGTC population included all participants who had at least 1 SGTC seizure during either Baseline or double-blind phase. n=number of participants evaluable at specific time points for each arm group, respectively.
Change in SGTC = (Proportion of SGTC/All Partial Seizure rate during at the double-blind phase) - (Proportion of SGTC/All Partial Seizure rate at Baseline). Negative values indicate reduction from baseline.
Outcome measures
| Measure |
Pregabalin
n=114 Participants
Pregabalin was initiated at 150 mg/day \[50 mg capsules orally three times a day (TID)\] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: \>=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
|
Gabapentin
n=114 Participants
Gabapentin was initiated at 300 mg/day \[100 mg capsules orally three times a day (TID)\] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (\>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
|
|---|---|---|
|
Change From Baseline in the 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Frequency at Week 21.
Baseline (n=114, 114)
|
56.53 percentage of all partial seizure/28days
Standard Deviation 40.856
|
59.60 percentage of all partial seizure/28days
Standard Deviation 40.571
|
|
Change From Baseline in the 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Frequency at Week 21.
Change from Baseline at Double Blind (n=104, 98)
|
1.59 percentage of all partial seizure/28days
Standard Deviation 28.164
|
-2.17 percentage of all partial seizure/28days
Standard Deviation 26.024
|
SECONDARY outcome
Timeframe: 6 weeks Baseline, 21 weeks through End of MP for 27 weeksPopulation: SGTC population included all participants who had at least 1 SGTC seizure during either Baseline or double-blind phase. n is the number of participants analyzed for SGTC. Twenty-six participants were not included in the n because they did not have a post Baseline all partial seizure, but they were included in the analysis by seizure type.
SGTC Responder is defined as a participant who shows reduction from Baseline to double-blind phase in proportion of 28-Day SGTC Seizure Rate to 28-Day All Partial Seizure Rate.
Outcome measures
| Measure |
Pregabalin
n=104 Participants
Pregabalin was initiated at 150 mg/day \[50 mg capsules orally three times a day (TID)\] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: \>=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
|
Gabapentin
n=98 Participants
Gabapentin was initiated at 300 mg/day \[100 mg capsules orally three times a day (TID)\] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (\>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
|
|---|---|---|
|
Reduction in Proportion of the 28-day SGTC Seizure Rate Over the Total Partial Seizure Rate at Week 21.
|
30.8 percentage of responders
Interval 21.9 to 39.6
|
39.8 percentage of responders
Interval 30.1 to 49.5
|
SECONDARY outcome
Timeframe: Baseline, Week 21Population: FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
HADS: participant rated questionnaire with 2 subscales. Hospital Anxiety and Depression Scale - anxiety (HADS-A) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); Hospital Anxiety and Depression Scale - depression (HADS-D) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Outcome measures
| Measure |
Pregabalin
n=238 Participants
Pregabalin was initiated at 150 mg/day \[50 mg capsules orally three times a day (TID)\] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: \>=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
|
Gabapentin
n=240 Participants
Gabapentin was initiated at 300 mg/day \[100 mg capsules orally three times a day (TID)\] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (\>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS) Score.
Baseline HADS-A (n=238, 240)
|
7.82 Units on a scale
Standard Error 0.31
|
7.60 Units on a scale
Standard Error 0.31
|
|
Hospital Anxiety and Depression Scale (HADS) Score.
HADS- A Change at Week 21/ET (n=212, 210)
|
-0.92 Units on a scale
Standard Error 0.26
|
-0.83 Units on a scale
Standard Error 0.27
|
|
Hospital Anxiety and Depression Scale (HADS) Score.
Baseline HADS-D (n=238, 240)
|
5.94 Units on a scale
Standard Error 0.29
|
5.65 Units on a scale
Standard Error 0.29
|
|
Hospital Anxiety and Depression Scale (HADS) Score.
HADS-D Change at Week 21/ET (n=212, 210)
|
-0.59 Units on a scale
Standard Error 0.24
|
-0.42 Units on a scale
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Baseline, Week 21Population: FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. n=number of participants evaluable at specific time points for each arm group, respectively.
Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity (range:0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except adequacy, optimal sleep and quantity, higher scores=more impairment. Scores transformed (actual raw score \[RS\] minus lowest possible score divided by possible RS range\*100); total score range:0-100; higher score=more intensity of attribute.
Outcome measures
| Measure |
Pregabalin
n=238 Participants
Pregabalin was initiated at 150 mg/day \[50 mg capsules orally three times a day (TID)\] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: \>=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
|
Gabapentin
n=240 Participants
Gabapentin was initiated at 300 mg/day \[100 mg capsules orally three times a day (TID)\] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (\>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
|
|---|---|---|
|
Medical Outcomes Study Sleep Scale (MOS-SS) Score.
Baseline: Sleep Disturbance (n=238, 240)
|
29.68 Units on a scale
Standard Error 1.70
|
26.43 Units on a scale
Standard Error 1.70
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) Score.
Baseline: Snoring (n=238, 240)
|
29.28 Units on a scale
Standard Error 2.31
|
28.09 Units on a scale
Standard Error 2.31
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) Score.
Baseline: Awaken Short of Breath (n=238, 240)
|
23.64 Units on a scale
Standard Error 2.07
|
19.61 Units on a scale
Standard Error 2.07
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) Score.
Baseline: Quantity of Sleep (n=238, 240)
|
7.56 Units on a scale
Standard Error 0.11
|
7.59 Units on a scale
Standard Error 0.11
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) Score.
Baseline: Adequacy of Sleep (n=238, 240)
|
61.30 Units on a scale
Standard Error 2.01
|
63.67 Units on a scale
Standard Error 2.01
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) Score.
Baseline: Somnolence (n=238, 240)
|
32.29 Units on a scale
Standard Error 1.56
|
29.31 Units on a scale
Standard Error 1.56
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) Score.
Baseline: Sleep Problem Index (9) (n=238, 240)
|
31.60 Units on a scale
Standard Error 1.32
|
28.15 Units on a scale
Standard Error 1.32
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) Score.
Week 21: Sleep Disturbance (n=212, 210)
|
24.99 Units on a scale
Standard Error 1.37
|
25.31 Units on a scale
Standard Error 1.39
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) Score.
Week 21: Snoring (n=212, 210)
|
28.07 Units on a scale
Standard Error 1.89
|
26.12 Units on a scale
Standard Error 1.90
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) Score.
Week 21: Awaken Short of Breath (n=212, 210)
|
16.26 Units on a scale
Standard Error 1.73
|
18.20 Units on a scale
Standard Error 1.74
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) Score.
Week 21: Quantity of Sleep (n=212, 210)
|
8.79 Units on a scale
Standard Error 0.17
|
8.77 Units on a scale
Standard Error 0.17
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) Score.
Week 21: Adequacy of Sleep (n=212, 210)
|
63.87 Units on a scale
Standard Error 1.68
|
64.53 Units on a scale
Standard Error 1.69
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) Score.
Week 21: Somnolence (n=212, 210)
|
32.04 Units on a scale
Standard Error 1.36
|
29.98 Units on a scale
Standard Error 1.37
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) Score.
Week 21: Sleep Problem Index (9) (n=212, 210)
|
27.88 Units on a scale
Standard Error 1.04
|
27.54 Units on a scale
Standard Error 1.05
|
SECONDARY outcome
Timeframe: Baseline, Week 21Population: FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. n=number of participants evaluable at specifictime points for each arm group, respectively.
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Percentage of participants with optimal sleep are reported.
Outcome measures
| Measure |
Pregabalin
n=238 Participants
Pregabalin was initiated at 150 mg/day \[50 mg capsules orally three times a day (TID)\] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: \>=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
|
Gabapentin
n=240 Participants
Gabapentin was initiated at 300 mg/day \[100 mg capsules orally three times a day (TID)\] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (\>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
|
|---|---|---|
|
Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score.
Baseline (n=238, 240)
|
49.2 percentage of participants
|
58.8 percentage of participants
|
|
Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score.
Week 21 (n=212, 210)
|
51.4 percentage of participants
|
58.6 percentage of participants
|
Adverse Events
Pregabalin
Serious events: 13 serious events
Other events: 77 other events
Deaths: 0 deaths
Gabapentin
Serious events: 14 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregabalin
n=241 participants at risk
Pregabalin was initiated at 150 mg/day \[50 mg capsules orally three times a day (TID)\] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: \>=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
|
Gabapentin
n=241 participants at risk
Gabapentin was initiated at 300 mg/day \[100 mg capsules orally three times a day (TID)\] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (\>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Pericardial effusion
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Diplopia
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hepatitis
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchopneumonia
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Encephalitis viral
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Influenza
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.83%
2/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cerebral disorder
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Convulsion
|
1.2%
3/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.83%
2/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Grand mal convulsion
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hemiparesis
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Loss of consciousness
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.83%
2/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Suicidal ideation
|
0.83%
2/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Withdrawal syndrome
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Urogenital fistula
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
0.41%
1/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Pregabalin
n=241 participants at risk
Pregabalin was initiated at 150 mg/day \[50 mg capsules orally three times a day (TID)\] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: \>=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
|
Gabapentin
n=241 participants at risk
Gabapentin was initiated at 300 mg/day \[100 mg capsules orally three times a day (TID)\] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (\>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
|
|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
12/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.3%
8/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight increased
|
9.5%
23/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.2%
15/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
9.1%
22/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.7%
21/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
8.7%
21/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
10.4%
25/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Somnolence
|
14.5%
35/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
14.1%
34/241
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant 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