A Phase 3 interventional study of 2 mg perampanel and 4 mg perampanel in Parkinson's Disease, sponsored by Eisai Inc.. Completed at 114 sites in 2 countries. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2013-05-20.
Sponsored by Eisai Inc. · Phase 3, Interventional, and Treatment
This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study of E2007 in levodopa treated Parkinson's disease patients with motor fluctuations.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 752 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Eisai Inc. is the lead sponsor of 360 studies on the registry; 7 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 54 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
EXCLUSION CRITERIA:
The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
Drug: 2 mg perampanel
The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
Drug: 4 mg perampanel
The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
Drug: placebo comparator
2 mg perampanel
4 mg perampanel
placebo comparator
Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data)
Patients described themselves in home diaries as "OFF", "ON" without dyskinesias, "ON" with non troublesome dyskinesias, "ON" with troublesome dyskinesias, or Asleep, every 30 minutes during waking hours for 3 consecutive days prior to Baseline, Weeks 8, 10, 18, and 20. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.
Time frame: Baseline and Week 20
Mean Change From Baseline in Scale UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 20 (Including LOCF Data)
Patients described themselves in home diaries every 30 minutes during waking hours for 3 consecutive days prior to Baseline, Weeks 8, 12, 16, and 20. 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.
Time frame: Baseline and Week 20
Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 20 (Including LOCF Data)
Patients described themselves in home diaries every 30 minutes during waking hours for 3 days prior to Baseline, Weeks 8, 12, 16, and 20. UPDRS is a standardized assessment of the symptoms and signs of PD. 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.
Time frame: Baseline and Week 20
Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) to Week 20 (Including LOCF Data)
Patients described themselves in home diaries every 30 minutes during waking hours for 3 days prior to Baseline, Weeks 8, 12, 16, and 20. ON state is when medication is providing benefits to stiffness, slowness, and tremor.
Time frame: Baseline and Week 20
| Milestone | Placebo | Perampanel 2mg | Perampanel 4mg |
|---|---|---|---|
| Started | 251 | 251 | 250 |
| Completed | 187 | 198 | 182 |
| Not completed | 64 | 53 | 68 |
| Withdrew: Adverse event | 38 | 26 | 44 |
| Withdrew: Abnormal laboratory value | 0 | 0 | 3 |
| Withdrew: Protocol violation | 5 | 9 | 9 |
| Withdrew: Withdrawal by subject | 9 | 3 | 5 |
| Withdrew: Lack of efficacy | 7 | 8 | 5 |
| Withdrew: Physician decision | 2 | 0 | 1 |
| Withdrew: Other | 3 | 7 | 1 |
Patients described themselves in home diaries as "OFF", "ON" without dyskinesias, "ON" with non troublesome dyskinesias, "ON" with troublesome dyskinesias, or Asleep, every 30 minutes during waking hours for 3 consecutive days prior to Baseline, Weeks 8, 10, 18, and 20. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.
| Hours | Placebo | Perampanel 2mg | Perampanel 4mg |
|---|---|---|---|
| Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data) | -0.96 (-1.42 to -0.51) | -0.93 (-1.38 to -0.49) | -0.76 (-1.20 to -0.31) |
Patients described themselves in home diaries every 30 minutes during waking hours for 3 consecutive days prior to Baseline, Weeks 8, 12, 16, and 20. 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.
| Scores on a scale | Placebo | Perampanel 2mg | Perampanel 4mg |
|---|---|---|---|
| Mean Change From Baseline in Scale UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 20 (Including LOCF Data) | -0.85 (-1.70 to -0.00) | -0.81 (-1.66 to 0.04) | -1.40 (-2.23 to -0.56) |
Patients described themselves in home diaries every 30 minutes during waking hours for 3 days prior to Baseline, Weeks 8, 12, 16, and 20. UPDRS is a standardized assessment of the symptoms and signs of PD. 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.
| Scores on a Scale | Placebo | Perampanel 2mg | Perampanel 4mg |
|---|---|---|---|
| Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 20 (Including LOCF Data) | -2.15 (-3.59 to -0.71) | -1.69 (-3.13 to -0.25) | -3.29 (-4.71 to -1.87) |
Patients described themselves in home diaries every 30 minutes during waking hours for 3 days prior to Baseline, Weeks 8, 12, 16, and 20. ON state is when medication is providing benefits to stiffness, slowness, and tremor.
| Hours | Placebo | Perampanel 2mg | Perampanel 4mg |
|---|---|---|---|
| Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) to Week 20 (Including LOCF Data) | 0.73 (0.29 to 1.18) | 0.78 (0.33 to 1.22) | 0.28 (-0.15 to 0.72) |
Collected over From the time the subject signed the informed consent form to 30 days after the last dose of the study drug.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 22/250 (8.8%) | 111/250 (44.4%) |
| Perampanel 2mg | — | 12/251 (4.8%) | 110/251 (43.8%) |
| Perampanel 4mg | — | 18/250 (7.2%) | 144/250 (57.6%) |
| Event | Placebo | Perampanel 2mg | Perampanel 4mg |
|---|---|---|---|
| Myocardial infarctionCardiac disorders | 2/250 | 1/251 | 0/250 |
| PneumoniaInfections and infestations | 2/250 | 0/251 | 2/250 |
| Hip fractureInjury, poisoning and procedural complications | 2/250 | 0/251 | 1/250 |
| SyncopeNervous system disorders | 1/250 | 1/251 | 1/250 |
| Cerebrovascular accidentNervous system disorders | 0/250 | 0/251 | 1/250 |
| Memory ImpairmentNervous system disorders | 0/250 | 0/251 | 1/250 |
| Myasthenia gravisNervous system disorders | 0/250 | 0/251 | 1/250 |
| QuadriparesisNervous system disorders | 0/250 | 0/251 | 1/250 |
| Reversible ischaemic neurological deficitNervous system disorders | 1/250 | 0/251 | 0/250 |
| Tonic convulsionNervous system disorders | 1/250 | 0/251 | 0/250 |
| Event | Placebo | Perampanel 2mg | Perampanel 4mg |
|---|---|---|---|
| DyskinesiaNervous system disorders | 39/250 | 21/251 | 43/250 |
| SomnolenceNervous system disorders | 13/250 | 32/251 | 40/250 |
| DizzinessNervous system disorders | 14/250 | 15/251 | 29/250 |
| ON and OFF phenomenonNervous system disorders | 24/250 | 18/251 | 21/250 |
| FallInjury, poisoning and procedural complications | 23/250 | 23/251 | 19/250 |
| HeadacheNervous system disorders | 18/250 | 10/251 | 12/250 |
| Balance DisorderNervous system disorders | 3/250 | 6/251 | 17/250 |
| NauseaGastrointestinal disorders | 16/250 | 11/251 | 12/250 |
| Back PainMusculoskeletal and connective tissue disorders | 7/250 | 16/251 | 12/250 |
| InsomniaPsychiatric disorders | 15/250 | 14/251 | 15/250 |
| Age, Customized(Participants) | Placebo | Perampanel 2mg | Perampanel 4mg | Total |
|---|---|---|---|---|
| <65 years | 149 | 144 | 147 | 440 |
| ≥ 65 years | 101 | 107 | 103 | 311 |
| Sex: Female, Male(Participants) | Placebo | Perampanel 2mg | Perampanel 4mg | Total |
|---|---|---|---|---|
| Female | 86 | 87 | 86 | 259 |
| Male | 164 | 164 | 164 | 492 |
| Race/Ethnicity, Customized(Participants) | Placebo | Perampanel 2mg | Perampanel 4mg | Total |
|---|---|---|---|---|
| White | 233 | 239 | 240 | 712 |
| Black | 4 | 2 | 1 | 7 |
| Asian | 5 | 4 | 1 | 10 |
| Other | 8 | 6 | 8 | 22 |
Showing the first 100 of 114 sites across 2 countries.
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Eisai Inc.