Trial Outcomes & Findings for Evaluating the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures (NCT NCT00699972)
NCT ID: NCT00699972
Last Updated: 2020-01-10
Results Overview
Seizure frequency per 28 days was derived from the information recorded in the subject diaries.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
390 participants
Primary outcome timeframe
Baseline (Pre-randomization) through Week 19
Results posted on
2020-01-10
Participant Flow
A total of 534 participants were screened for entry into the study. Of 534 participants, 147 were screen failures and 387 were eligible to continue in the study. A total of 390 participants were randomized into the study; 387 who were eligible and 3 who failed screening but were inappropriately randomized (2 received study treatment and 1 did not).
This was a randomized, double-blind, placebo-controlled study consisting of three phases: Prerandomization, Double-blind, and Follow-up. Participants who experienced the required minimum number of seizures during prerandomization, entered the Double-blind Phase and were randomized to placebo or 8 or 12 mg perampanel groups.
Participant milestones
| Measure |
Placebo
6 placebo tablets received daily during both Titration and Maintenance Periods.
|
Perampanel 8mg
Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
|
Perampanel 12mg
Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
|
|---|---|---|---|
|
Overall Study
STARTED
|
122
|
133
|
135
|
|
Overall Study
COMPLETED
|
106
|
114
|
100
|
|
Overall Study
NOT COMPLETED
|
16
|
19
|
35
|
Reasons for withdrawal
| Measure |
Placebo
6 placebo tablets received daily during both Titration and Maintenance Periods.
|
Perampanel 8mg
Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
|
Perampanel 12mg
Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
7
|
9
|
24
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
7
|
4
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
2
|
|
Overall Study
Administrative/Other
|
3
|
1
|
4
|
|
Overall Study
Randomized, Not Treated
|
1
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo
n=121 Participants
6 placebo tablets received daily during both Titration and Maintenance Periods.
|
Perampanel 8mg
n=133 Participants
Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
|
Perampanel 12mg
n=134 Participants
Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
|
Total
n=388 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<18 years
|
14 participants
n=121 Participants
|
15 participants
n=133 Participants
|
10 participants
n=134 Participants
|
39 participants
n=388 Participants
|
|
Age, Customized
18-64 years
|
102 participants
n=121 Participants
|
116 participants
n=133 Participants
|
119 participants
n=134 Participants
|
337 participants
n=388 Participants
|
|
Age, Customized
>64 years
|
5 participants
n=121 Participants
|
2 participants
n=133 Participants
|
5 participants
n=134 Participants
|
12 participants
n=388 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=121 Participants
|
68 Participants
n=133 Participants
|
65 Participants
n=134 Participants
|
200 Participants
n=388 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=121 Participants
|
65 Participants
n=133 Participants
|
69 Participants
n=134 Participants
|
188 Participants
n=388 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Race/Ethnicity, Customized
White
|
103 participants
n=121 Participants
|
115 participants
n=133 Participants
|
116 participants
n=134 Participants
|
334 participants
n=388 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
13 participants
n=121 Participants
|
6 participants
n=133 Participants
|
8 participants
n=134 Participants
|
27 participants
n=388 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=121 Participants
|
1 participants
n=133 Participants
|
1 participants
n=134 Participants
|
2 participants
n=388 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
0 participants
n=121 Participants
|
1 participants
n=133 Participants
|
1 participants
n=134 Participants
|
2 participants
n=388 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=121 Participants
|
4 participants
n=133 Participants
|
2 participants
n=134 Participants
|
6 participants
n=388 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 participants
n=121 Participants
|
6 participants
n=133 Participants
|
6 participants
n=134 Participants
|
17 participants
n=388 Participants
|
PRIMARY outcome
Timeframe: Baseline (Pre-randomization) through Week 19Population: Full Intent-to-Treat (ITT) Analysis Set included all participants who were randomized to study drug, received study drug, and had any seizure frequency data during the Double-blind Phase.
Seizure frequency per 28 days was derived from the information recorded in the subject diaries.
Outcome measures
| Measure |
Placebo
n=121 Participants
6 placebo tablets received daily during both Titration and Maintenance Periods.
|
Perampanel 8mg
n=133 Participants
Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
|
Perampanel 12mg
n=133 Participants
Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
|
|---|---|---|---|
|
Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)
|
-20.95 Percent Change in seizure frequency
Interval -100.0 to 397.5
|
-26.34 Percent Change in seizure frequency
Interval -100.0 to 150.7
|
-34.49 Percent Change in seizure frequency
Interval -100.0 to 659.7
|
SECONDARY outcome
Timeframe: Baseline (Pre-randomization) through Week 19Population: Full ITT Analysis Set; Last Observation Carried Forward (LOCF)
A responder was a participant who had a 50 percent or greater reduction in seizure frequency per 28 days from the Pre-randomization phase.
Outcome measures
| Measure |
Placebo
n=121 Participants
6 placebo tablets received daily during both Titration and Maintenance Periods.
|
Perampanel 8mg
n=133 Participants
Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
|
Perampanel 12mg
n=133 Participants
Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
|
|---|---|---|---|
|
Percentage of Participants Who Were Responders
Yes (Responder)
|
26.4 Percentage of Participants
|
37.6 Percentage of Participants
|
36.1 Percentage of Participants
|
|
Percentage of Participants Who Were Responders
No (Non-Responder)
|
73.6 Percentage of Participants
|
62.4 Percentage of Participants
|
63.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-randomization) through Week 19Population: Full ITT Analysis Set
Percent Change in the Seizure frequency per 28 days was derived from the information recorded in the subject diaries.
Outcome measures
| Measure |
Placebo
n=110 Participants
6 placebo tablets received daily during both Titration and Maintenance Periods.
|
Perampanel 8mg
n=120 Participants
Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
|
Perampanel 12mg
n=120 Participants
Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
|
|---|---|---|---|
|
Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)
|
-17.88 Percent Change
Interval -100.0 to 653.5
|
-33.03 Percent Change
Interval -100.0 to 150.7
|
-33.06 Percent Change
Interval -100.0 to 1006.5
|
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 71 other events
Deaths: 0 deaths
Perampanel 8mg
Serious events: 8 serious events
Other events: 101 other events
Deaths: 0 deaths
Perampanel 12mg
Serious events: 9 serious events
Other events: 98 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=121 participants at risk
6 placebo tablets received daily during both Titration and Maintenance Periods.
|
Perampanel 8mg
n=133 participants at risk
Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
|
Perampanel 12mg
n=134 participants at risk
Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
|
|---|---|---|---|
|
Nervous system disorders
Convulsion
|
0.00%
0/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.75%
1/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
1.5%
2/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Nervous system disorders
Grand mal convulsion
|
0.83%
1/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.75%
1/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.75%
1/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.75%
1/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.75%
1/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Nervous system disorders
Presyncope
|
0.83%
1/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.75%
1/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.75%
1/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.75%
1/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.75%
1/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Psychiatric disorders
Impulse-control disorder
|
0.00%
0/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.75%
1/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.75%
1/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Psychiatric disorders
Delirium
|
0.83%
1/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Psychiatric disorders
Depression
|
0.83%
1/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Psychiatric disorders
Psychotic disorder
|
0.83%
1/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.75%
1/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.75%
1/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Injury, poisoning and procedural complications
Multiple drug overdose intentional
|
0.00%
0/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.75%
1/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.75%
1/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.83%
1/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.83%
1/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
1.5%
2/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Gastrointestinal disorders
Omental infarction
|
0.00%
0/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.75%
1/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.75%
1/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.75%
1/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.75%
1/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.75%
1/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Surgical and medical procedures
Skin graft
|
0.83%
1/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
0.00%
0/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
Other adverse events
| Measure |
Placebo
n=121 participants at risk
6 placebo tablets received daily during both Titration and Maintenance Periods.
|
Perampanel 8mg
n=133 participants at risk
Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
|
Perampanel 12mg
n=134 participants at risk
Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
|
|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
2.5%
3/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
5.3%
7/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
5.2%
7/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Psychiatric disorders
Insomnia
|
5.0%
6/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
6.0%
8/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
6.0%
8/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
3.0%
4/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
5.2%
7/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.6%
8/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
6.8%
9/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
4.5%
6/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
6.6%
8/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
6.8%
9/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
6.0%
8/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
4.1%
5/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
3.0%
4/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
5.2%
7/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
General disorders
Fatigue
|
4.1%
5/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
7.5%
10/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
8.2%
11/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
General disorders
Irritability
|
5.0%
6/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
7.5%
10/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
14.2%
19/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Infections and infestations
Influenza
|
6.6%
8/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
4.5%
6/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
3.0%
4/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
6/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
7.5%
10/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
4.5%
6/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Injury, poisoning and procedural complications
Fall
|
6.6%
8/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
9.8%
13/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
12.7%
17/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Investigations
Weight increased
|
0.83%
1/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
6.0%
8/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
3.0%
4/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
3/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
1.5%
2/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
5.2%
7/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
6.0%
8/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
11.9%
16/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Nervous system disorders
Balance disorder
|
0.83%
1/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
7.5%
10/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
3.7%
5/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Nervous system disorders
Dizziness
|
9.9%
12/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
37.6%
50/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
38.1%
51/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Nervous system disorders
Headache
|
13.2%
16/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
15.0%
20/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
13.4%
18/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Nervous system disorders
Somnolence
|
13.2%
16/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
18.0%
24/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
17.2%
23/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
3/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
4.5%
6/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
6.0%
8/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Nervous system disorders
Convulsion
|
1.7%
2/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
5.3%
7/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
3.0%
4/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/121 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
2.3%
3/133 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
5.2%
7/134 • From the first dose of study drug up to 30 days after the last dose of the study drug (up to Day 161)
Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
|
Additional Information
Eisai Inc.
Eisai Call Center
Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER