Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00368108
First received: August 22, 2006
Last updated: May 13, 2013
Last verified: January 2013
Results First Received: October 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Parkinson's Disease
Interventions: Drug: 2 mg perampanel
Drug: 4 mg perampanel
Drug: placebo comparator

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo 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.
Perampanel 2mg 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.
Perampanel 4mg 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 perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.

Participant Flow:   Overall Study
    Placebo     Perampanel 2mg     Perampanel 4mg  
STARTED     251 [1]   251     250  
COMPLETED     187     198     182  
NOT COMPLETED     64     53     68  
Adverse Event                 38                 26                 44  
Abnormal Laboratory Value                 0                 0                 3  
Protocol Violation                 5                 9                 9  
Withdrawal by Subject                 9                 3                 5  
Lack of Efficacy                 7                 8                 5  
Physician Decision                 2                 0                 1  
Not Specified                 3                 7                 1  
[1] One subject had stopped medication prior to notifying staff. Remaining results will have 250.



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data)   [ Time Frame: Baseline and Week 20 ]

2.  Secondary:   Mean Change From Baseline in Scale UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 20 (Including LOCF Data)   [ Time Frame: Baseline and Week 20 ]

3.  Secondary:   Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 20 (Including LOCF Data)   [ Time Frame: Baseline and Week 20 ]

4.  Secondary:   Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) to Week 20 (Including LOCF Data)   [ Time Frame: Baseline and Week 20 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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