Trial Outcomes & Findings for Exploring the Safety And Tolerability of Doses of E2007 up to a Maximum of 12 mg In Patients With Refractory Partial Seizures (NCT NCT00416195)
NCT ID: NCT00416195
Last Updated: 2014-07-11
Results Overview
A patient is a responder if she/he experiences a 50% or greater reduction in seizure frequency from the baseline phase.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Day 85 through Day 112
Results posted on
2014-07-11
Participant Flow
Participant milestones
| Measure |
Placebo
Matching placebo once daily for 16 weeks (Days 1 to 112)
|
Perampanel
2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase \[Days 71 to 84\] and a 4-week Maintenance Phase \[Days 85 to 112\])
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
38
|
|
Overall Study
COMPLETED
|
8
|
34
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Matching placebo once daily for 16 weeks (Days 1 to 112)
|
Perampanel
2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase \[Days 71 to 84\] and a 4-week Maintenance Phase \[Days 85 to 112\])
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Exploring the Safety And Tolerability of Doses of E2007 up to a Maximum of 12 mg In Patients With Refractory Partial Seizures
Baseline characteristics by cohort
| Measure |
Placebo
n=10 Participants
Matching placebo once daily for 16 weeks (Days 1 to 112)
|
Perampanel
n=38 Participants
2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase \[Days 71 to 84\] and a 4-week Maintenance Phase \[Days 85 to 112\])
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 12.05 • n=5 Participants
|
40.7 years
STANDARD_DEVIATION 11.99 • n=7 Participants
|
43.1 years
STANDARD_DEVIATION 12.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
10 participants
n=5 Participants
|
38 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 85 through Day 112Population: ITT population- all subjects in the Safety Population (all randomized subjects who took at least 1 dose of study drug) who had at least 2 weeks of baseline seizure frequency data and at least 1 week of seizure frequency data after baseline (LOCF - last observation carried forward)
A patient is a responder if she/he experiences a 50% or greater reduction in seizure frequency from the baseline phase.
Outcome measures
| Measure |
Placebo
n=9 Participants
Matching placebo once daily for 16 weeks (Days 1 to 112)
|
Perampanel
n=38 Participants
2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase \[Days 71 to 84\] and a 4-week Maintenance Phase \[Days 85 to 112\])
|
|---|---|---|
|
Percentage of Responders During the Maintenance Phase
Responders (Yes)
|
44.4 Percentage of Participants
|
34.2 Percentage of Participants
|
|
Percentage of Responders During the Maintenance Phase
Non-Responders (No)
|
55.6 Percentage of Participants
|
65.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 85 through Day 112Population: ITT population (LOCF)
Outcome measures
| Measure |
Placebo
n=9 Participants
Matching placebo once daily for 16 weeks (Days 1 to 112)
|
Perampanel
n=38 Participants
2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase \[Days 71 to 84\] and a 4-week Maintenance Phase \[Days 85 to 112\])
|
|---|---|---|
|
Percentage Change in the 28-day Seizure Frequency From Baseline in the Maintenance LOCF
|
-46.4 Percent change
Interval -81.5 to 221.0
|
-35.4 Percent change
Interval -100.0 to 93.3
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Perampanel
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=10 participants at risk
Matching placebo once daily for 16 weeks (Days 1 to 112)
|
Perampanel
n=38 participants at risk
2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase \[Days 71 to 84\] and a 4-week Maintenance Phase \[Days 85 to 112\])
|
|---|---|---|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/10
|
2.6%
1/38
|
|
Nervous system disorders
Convulsions
|
10.0%
1/10
|
0.00%
0/38
|
Other adverse events
| Measure |
Placebo
n=10 participants at risk
Matching placebo once daily for 16 weeks (Days 1 to 112)
|
Perampanel
n=38 participants at risk
2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase \[Days 71 to 84\] and a 4-week Maintenance Phase \[Days 85 to 112\])
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10
|
5.3%
2/38
|
|
Infections and infestations
Rhinitis
|
0.00%
0/10
|
5.3%
2/38
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
10.0%
1/10
|
0.00%
0/38
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10
|
15.8%
6/38
|
|
Nervous system disorders
Headache
|
10.0%
1/10
|
2.6%
1/38
|
|
Nervous system disorders
Muscle contractions involuntary
|
10.0%
1/10
|
0.00%
0/38
|
|
Nervous system disorders
Somnolence
|
0.00%
0/10
|
7.9%
3/38
|
|
Psychiatric disorders
Anxiety
|
20.0%
2/10
|
0.00%
0/38
|
|
Vascular disorders
Hypertension
|
10.0%
1/10
|
2.6%
1/38
|
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