Trial Outcomes & Findings for A Study of E2007 In Patients With Parkinson's Disease (NCT NCT00427011)
NCT ID: NCT00427011
Last Updated: 2013-02-11
Results Overview
OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Baseline, Week 12, Week 20, Week 32, Week 44, Week 56
Results posted on
2013-02-11
Participant Flow
Participant milestones
| Measure |
Perampanel
Subjects entered this open-label extension study from the double-blind core study E2007-A001-214 (NCT00165789), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
Perampanel
Subjects entered this open-label extension study from the double-blind core study E2007-A001-214 (NCT00165789), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
|
|---|---|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Other
|
12
|
Baseline Characteristics
A Study of E2007 In Patients With Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Perampanel
n=25 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
|
|---|---|
|
Age Continuous
|
69 years
STANDARD_DEVIATION 8.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
23 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56Population: Safety population.
OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.
Outcome measures
| Measure |
Perampanel (Placebo During Core Study)
n=9 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
|
Perampanel (Perampanel During Core Study)
n=16 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
|
|---|---|---|
|
Mean Change From Baseline by Visit in Absolute OFF Time (Hours) During Open-label Extension Study
Week 12 (n=2,10)
|
-2.17 hours
Standard Deviation 4.714
|
-1.18 hours
Standard Deviation 3.400
|
|
Mean Change From Baseline by Visit in Absolute OFF Time (Hours) During Open-label Extension Study
Week 20 (n=2,8)
|
-0.50 hours
Standard Deviation 4.714
|
-0.29 hours
Standard Deviation 3.261
|
|
Mean Change From Baseline by Visit in Absolute OFF Time (Hours) During Open-label Extension Study
Week 32 (n=2,10)
|
-0.25 hours
Standard Deviation 6.718
|
-0.97 hours
Standard Deviation 2.765
|
|
Mean Change From Baseline by Visit in Absolute OFF Time (Hours) During Open-label Extension Study
Week 44 (n=0,7)
|
NA hours
Standard Deviation NA
Insufficient data due to early withdrawals/study termination.
|
-0.81 hours
Standard Deviation 2.678
|
|
Mean Change From Baseline by Visit in Absolute OFF Time (Hours) During Open-label Extension Study
Week 56 (n=0,0)
|
NA hours
Standard Deviation NA
Insufficient data due to early withdrawals/study termination.
|
NA hours
Standard Deviation NA
Insufficient data due to early withdrawals/study termination.
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56Population: Safety population.
ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.
Outcome measures
| Measure |
Perampanel (Placebo During Core Study)
n=9 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
|
Perampanel (Perampanel During Core Study)
n=16 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
|
|---|---|---|
|
Mean Change From Baseline by Visit in Absolute ON Time (Without Dyskinesias or With Nontroublesome Dyskinesias) (Hours) During Open-label Extension Study
Week 12 (n=2,10)
|
1.42 hours
Standard Deviation 3.889
|
1.15 hours
Standard Deviation 3.162
|
|
Mean Change From Baseline by Visit in Absolute ON Time (Without Dyskinesias or With Nontroublesome Dyskinesias) (Hours) During Open-label Extension Study
Week 20 (n=2,8)
|
-0.17 hours
Standard Deviation 2.357
|
0.69 hours
Standard Deviation 1.838
|
|
Mean Change From Baseline by Visit in Absolute ON Time (Without Dyskinesias or With Nontroublesome Dyskinesias) (Hours) During Open-label Extension Study
Week 32 (n=2,10)
|
0.08 hours
Standard Deviation 3.418
|
1.18 hours
Standard Deviation 2.905
|
|
Mean Change From Baseline by Visit in Absolute ON Time (Without Dyskinesias or With Nontroublesome Dyskinesias) (Hours) During Open-label Extension Study
Week 44 (n=0,7)
|
NA hours
Standard Deviation NA
Insufficient data due to early withdrawals/study termination.
|
0.93 hours
Standard Deviation 2.757
|
|
Mean Change From Baseline by Visit in Absolute ON Time (Without Dyskinesias or With Nontroublesome Dyskinesias) (Hours) During Open-label Extension Study
Week 56 (n=0,0)
|
NA hours
Standard Deviation NA
Insufficient data due to early withdrawals/study termination.
|
NA hours
Standard Deviation NA
Insufficient data due to early withdrawals/study termination.
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56Population: Safety population.
Unified Parkinson's Disease (PD) Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of PD. 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. Range of possible total scores, 0 to 52. ON state is when medication is providing benefits to mobility, slowness, and stiffness. 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=9 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
|
Perampanel (Perampanel During Core Study)
n=16 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
|
|---|---|---|
|
Mean Change From Baseline by Visit in UPDRS Part II (ADL) in OFF State (Hours) During Open-label Extension Study
Week 12 (n=2,11)
|
7.50 scores on a scale
Standard Deviation 0.707
|
-1.27 scores on a scale
Standard Deviation 4.777
|
|
Mean Change From Baseline by Visit in UPDRS Part II (ADL) in OFF State (Hours) During Open-label Extension Study
Week 20 (n=1,12)
|
8.00 scores on a scale
Standard Deviation NA
Insufficient data due to early withdrawals/study termination.
|
-1.33 scores on a scale
Standard Deviation 4.979
|
|
Mean Change From Baseline by Visit in UPDRS Part II (ADL) in OFF State (Hours) During Open-label Extension Study
Week 32 (n=1,11)
|
NA scores on a scale
Standard Deviation NA
Insufficient data due to early withdrawals/study termination.
|
0.55 scores on a scale
Standard Deviation 5.007
|
|
Mean Change From Baseline by Visit in UPDRS Part II (ADL) in OFF State (Hours) During Open-label Extension Study
Week 44 (n=1,8)
|
2.00 scores on a scale
Standard Deviation NA
Insufficient data due to early withdrawals/study termination.
|
1.63 scores on a scale
Standard Deviation 5.706
|
|
Mean Change From Baseline by Visit in UPDRS Part II (ADL) in OFF State (Hours) During Open-label Extension Study
Week 56 (n=0,5)
|
NA scores on a scale
Standard Deviation NA
Insufficient data due to early withdrawals/study termination.
|
1 scores on a scale
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56Population: Safety population.
The 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. Range of possible total scores, 0 to 56. ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor.
Outcome measures
| Measure |
Perampanel (Placebo During Core Study)
n=9 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
|
Perampanel (Perampanel During Core Study)
n=16 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
|
|---|---|---|
|
Mean Change From Baseline by Visit in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study
Week 12 (n=3,12)
|
-3.67 scores on a scale
Standard Deviation 3.055
|
-2.67 scores on a scale
Standard Deviation 3.627
|
|
Mean Change From Baseline by Visit in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study
Week 20 (n=2,12)
|
-1.00 scores on a scale
Standard Deviation 7.071
|
-3.25 scores on a scale
Standard Deviation 8.996
|
|
Mean Change From Baseline by Visit in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study
Week 32 (n=2,11)
|
-8.00 scores on a scale
Standard Deviation 2.828
|
-1.91 scores on a scale
Standard Deviation 6.395
|
|
Mean Change From Baseline by Visit in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study
Week 44 (n=2,8)
|
-5.50 scores on a scale
Standard Deviation 7.778
|
-3.63 scores on a scale
Standard Deviation 8.210
|
|
Mean Change From Baseline by Visit in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study
Week 56 (n=0,5)
|
NA scores on a scale
Standard Deviation NA
Insufficient data due to early withdrawals/study termination.
|
-6.40 scores on a scale
Standard Deviation 7.829
|
Adverse Events
Perampanel
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Perampanel
n=25 participants at risk
Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
|
|---|---|
|
Nervous system disorders
Dysarthria
|
4.0%
1/25
|
|
Nervous system disorders
Somnolence
|
4.0%
1/25
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
4.0%
1/25
|
|
Psychiatric disorders
Confusional State
|
4.0%
1/25
|
Other adverse events
| Measure |
Perampanel
n=25 participants at risk
Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
|
|---|---|
|
Eye disorders
Cataract
|
8.0%
2/25
|
|
Eye disorders
Vision Blurred
|
8.0%
2/25
|
|
Gastrointestinal disorders
Constipation
|
8.0%
2/25
|
|
Gastrointestinal disorders
Nausea
|
8.0%
2/25
|
|
General disorders
Gait Disturbance
|
8.0%
2/25
|
|
General disorders
Irritability
|
8.0%
2/25
|
|
General disorders
Oedema Peripheral
|
12.0%
3/25
|
|
Injury, poisoning and procedural complications
Excoriation
|
8.0%
2/25
|
|
Injury, poisoning and procedural complications
Fall
|
12.0%
3/25
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
8.0%
2/25
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
2/25
|
|
Musculoskeletal and connective tissue disorders
Muscle Rigidity
|
8.0%
2/25
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
8.0%
2/25
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
12.0%
3/25
|
|
Nervous system disorders
Balance Disorder
|
12.0%
3/25
|
|
Nervous system disorders
Coordination Abnormal
|
16.0%
4/25
|
|
Nervous system disorders
Disturbance in Attention
|
8.0%
2/25
|
|
Nervous system disorders
Dizziness
|
32.0%
8/25
|
|
Nervous system disorders
Dyskinesia
|
24.0%
6/25
|
|
Nervous system disorders
Hyporeflexia
|
8.0%
2/25
|
|
Nervous system disorders
ON and OFF Phenomenon
|
32.0%
8/25
|
|
Nervous system disorders
Somnolence
|
28.0%
7/25
|
|
Nervous system disorders
Tremor
|
12.0%
3/25
|
|
Psychiatric disorders
Anxiety
|
8.0%
2/25
|
|
Psychiatric disorders
Confusional State
|
20.0%
5/25
|
|
Psychiatric disorders
Insomnia
|
8.0%
2/25
|
|
Renal and urinary disorders
Urinary Incontinence
|
12.0%
3/25
|
|
Vascular disorders
Orthostatic Hypotension
|
8.0%
2/25
|
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