Trial Outcomes & Findings for Evaluation of the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor Fluctuations (NCT NCT00505622)
NCT ID: NCT00505622
Last Updated: 2016-01-21
Results Overview
OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. All data was collected using a 3-day diary within a window of a defined visit.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
328 participants
Primary outcome timeframe
Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-up
Results posted on
2016-01-21
Participant Flow
Participant milestones
| Measure |
Perampanel (Placebo During Core Study)
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
Perampanel (Entacapone 200mg During Core Study)
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
Perampanel (Perampanel 4mg During Core Study)
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
121
|
108
|
96
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
121
|
108
|
96
|
Reasons for withdrawal
| Measure |
Perampanel (Placebo During Core Study)
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
Perampanel (Entacapone 200mg During Core Study)
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
Perampanel (Perampanel 4mg During Core Study)
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
6
|
4
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
2
|
|
Overall Study
Study termination by sponsor
|
115
|
98
|
90
|
Baseline Characteristics
Evaluation of the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor Fluctuations
Baseline characteristics by cohort
| Measure |
Perampanel (Placebo During Core Study)
n=121 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
Perampanel (Entacapone 200mg During Core Study)
n=108 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
Perampanel (Perampanel 4mg During Core Study)
n=96 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
Total
n=325 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<65
|
65 Particpants
n=5 Participants
|
52 Particpants
n=7 Participants
|
46 Particpants
n=5 Participants
|
163 Particpants
n=4 Participants
|
|
Age, Customized
>= 65
|
56 Particpants
n=5 Participants
|
56 Particpants
n=7 Participants
|
50 Particpants
n=5 Participants
|
162 Particpants
n=4 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
205 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
92 participants
n=5 Participants
|
75 participants
n=7 Participants
|
65 participants
n=5 Participants
|
232 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
29 participants
n=5 Participants
|
33 participants
n=7 Participants
|
31 participants
n=5 Participants
|
93 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-upPopulation: Safety Population - All subjects entering the open-label extension study who took at least 1 dose of perampanel.
OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. All data was collected using a 3-day diary within a window of a defined visit.
Outcome measures
| Measure |
Perampanel (Placebo During Core Study)
n=121 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
Perampanel (Entacapone 200mg During Core Study)
n=108 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
Perampanel (Perampanel 4mg During Core Study)
n=96 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
|---|---|---|---|
|
Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study
Week 8
|
-0.70 Hours
Standard Deviation 2.983
|
-1.16 Hours
Standard Deviation 2.509
|
-1.36 Hours
Standard Deviation 2.324
|
|
Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study
Week 0
|
-1.03 Hours
Standard Deviation 2.635
|
-1.07 Hours
Standard Deviation 2.595
|
-1.24 Hours
Standard Deviation 2.643
|
|
Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study
Week 2
|
-0.91 Hours
Standard Deviation 2.323
|
-1.28 Hours
Standard Deviation 2.867
|
-1.31 Hours
Standard Deviation 2.779
|
|
Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study
Week 4
|
-0.65 Hours
Standard Deviation 2.945
|
-1.15 Hours
Standard Deviation 2.010
|
-1.67 Hours
Standard Deviation 2.438
|
|
Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study
Week 20
|
-1.34 Hours
Standard Deviation 2.972
|
-1.14 Hours
Standard Deviation 1.805
|
-2.11 Hours
Standard Deviation 2.163
|
|
Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study
Follow-up
|
-0.77 Hours
Standard Deviation 2.983
|
-1.61 Hours
Standard Deviation 2.435
|
-0.94 Hours
Standard Deviation 2.978
|
SECONDARY outcome
Timeframe: Baseline, Week 0, Week 20, Week 32Population: Safety Population
Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part II assesses activities of daily living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.
Outcome measures
| Measure |
Perampanel (Placebo During Core Study)
n=121 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
Perampanel (Entacapone 200mg During Core Study)
n=108 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
Perampanel (Perampanel 4mg During Core Study)
n=96 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
|---|---|---|---|
|
Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study
Week 0
|
-0.84 Scores on a scale
Standard Deviation 4.241
|
-1.99 Scores on a scale
Standard Deviation 4.469
|
-1.66 Scores on a scale
Standard Deviation 4.598
|
|
Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study
Week 20
|
-0.12 Scores on a scale
Standard Deviation 4.727
|
-2.82 Scores on a scale
Standard Deviation 4.086
|
-2.66 Scores on a scale
Standard Deviation 4.972
|
|
Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study
Week 32
|
1.11 Scores on a scale
Standard Deviation 2.667
|
0.60 Scores on a scale
Standard Deviation 2.408
|
-0.67 Scores on a scale
Standard Deviation 3.141
|
SECONDARY outcome
Timeframe: Baseline, Week 0, Week 20, Week 32Population: Safety population
Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. ON state is when medication is providing benefits to stiffness, slowness, and tremor.
Outcome measures
| Measure |
Perampanel (Placebo During Core Study)
n=121 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
Perampanel (Entacapone 200mg During Core Study)
n=108 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
Perampanel (Perampanel 4mg During Core Study)
n=96 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
|---|---|---|---|
|
Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open-label Extension Study
Week 20
|
0.30 Scores on a scale
Standard Deviation 7.463
|
-0.53 Scores on a scale
Standard Deviation 6.950
|
-1.63 Scores on a scale
Standard Deviation 8.005
|
|
Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open-label Extension Study
Week 0
|
-0.25 Scores on a scale
Standard Deviation 6.874
|
-0.64 Scores on a scale
Standard Deviation 6.911
|
-0.96 Scores on a scale
Standard Deviation 6.999
|
|
Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open-label Extension Study
Week 32
|
2.22 Scores on a scale
Standard Deviation 5.869
|
-2.00 Scores on a scale
Standard Deviation 5.523
|
7.17 Scores on a scale
Standard Deviation 6.463
|
SECONDARY outcome
Timeframe: Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-upPopulation: Safety population
ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. All data was collected using a 3-day diary within a window of a defined visit.
Outcome measures
| Measure |
Perampanel (Placebo During Core Study)
n=121 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
Perampanel (Entacapone 200mg During Core Study)
n=108 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
Perampanel (Perampanel 4mg During Core Study)
n=96 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
|---|---|---|---|
|
Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study
Week 0
|
1.08 Hours
Standard Deviation 2.820
|
0.58 Hours
Standard Deviation 3.004
|
0.48 Hours
Standard Deviation 2.773
|
|
Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study
Week 2
|
0.30 Hours
Standard Deviation 2.776
|
0.80 Hours
Standard Deviation 2.731
|
0.91 Hours
Standard Deviation 2.940
|
|
Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study
Week 4
|
0.38 Hours
Standard Deviation 2.825
|
0.43 Hours
Standard Deviation 2.091
|
1.24 Hours
Standard Deviation 2.724
|
|
Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study
Week 8
|
0.17 Hours
Standard Deviation 3.099
|
0.52 Hours
Standard Deviation 2.542
|
0.73 Hours
Standard Deviation 2.261
|
|
Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study
Week 20
|
0.94 Hours
Standard Deviation 3.535
|
0.82 Hours
Standard Deviation 2.231
|
1.62 Hours
Standard Deviation 2.351
|
|
Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study
Follow-up
|
0.43 Hours
Standard Deviation 3.368
|
1.12 Hours
Standard Deviation 2.561
|
0.85 Hours
Standard Deviation 3.497
|
Adverse Events
Perampanel (Placebo During Core Study)
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
Perampanel (Entacapone 200mg During Core Study)
Serious events: 6 serious events
Other events: 27 other events
Deaths: 0 deaths
Perampanel (Perampanel 4mg During Core Study)
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Perampanel (Placebo During Core Study)
n=121 participants at risk
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
Perampanel (Entacapone 200mg During Core Study)
n=108 participants at risk
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
Perampanel (Perampanel 4mg During Core Study)
n=96 participants at risk
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
|---|---|---|---|
|
Nervous system disorders
Dementia
|
0.00%
0/121 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
0.93%
1/108 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
0.00%
0/96 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
|
Nervous system disorders
Parkinson's Disease
|
0.83%
1/121 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
0.00%
0/108 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
0.00%
0/96 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
|
Nervous system disorders
Radicular Syndrome
|
0.00%
0/121 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
0.93%
1/108 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
0.00%
0/96 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/121 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
0.93%
1/108 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
0.00%
0/96 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/121 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
0.93%
1/108 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
0.00%
0/96 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
|
General disorders
Chest Pain
|
0.00%
0/121 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
0.00%
0/108 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
1.0%
1/96 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/121 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
0.93%
1/108 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
0.00%
0/96 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.83%
1/121 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
0.00%
0/108 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
0.00%
0/96 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
|
Reproductive system and breast disorders
Uterine Prolapse
|
0.00%
0/121 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
0.00%
0/108 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
1.0%
1/96 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
|
Vascular disorders
Hypotension
|
0.00%
0/121 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
0.93%
1/108 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
0.00%
0/96 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
Other adverse events
| Measure |
Perampanel (Placebo During Core Study)
n=121 participants at risk
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
Perampanel (Entacapone 200mg During Core Study)
n=108 participants at risk
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
Perampanel (Perampanel 4mg During Core Study)
n=96 participants at risk
Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
6.6%
8/121 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
2.8%
3/108 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
4.2%
4/96 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
|
Nervous system disorders
Dyskinesia
|
3.3%
4/121 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
5.6%
6/108 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
5.2%
5/96 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
|
Nervous system disorders
On and Off Phenomenon
|
7.4%
9/121 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
11.1%
12/108 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
6.2%
6/96 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
|
Nervous system disorders
Parkinson's Disease
|
5.8%
7/121 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
2.8%
3/108 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
1.0%
1/96 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
|
Nervous system disorders
Somnolence
|
3.3%
4/121 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
5.6%
6/108 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
3.1%
3/96 • Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
|
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