A Study of E2007 In Patients With Parkinson's Disease

This study has been terminated.
(Study stopped due to lack of efficacy.)
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00427011
First received: January 24, 2007
Last updated: February 5, 2013
Last verified: February 2013
Results First Received: November 20, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Parkinson's Disease
Intervention: Drug: E2007

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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 Those subjects requiring more than two dose reductions were withdrawn.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.

Participant Flow:   Overall Study
    Perampanel  
STARTED     25  
COMPLETED     0  
NOT COMPLETED     25  
Adverse Event                 10  
Withdrawal by Subject                 1  
Lack of Efficacy                 2  
Not specified                 12  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Perampanel 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.

Baseline Measures
    Perampanel  
Number of Participants  
[units: participants]
  25  
Age [1]
[units: years]
Mean ± Standard Deviation
  69  ± 8.62  
Gender [2]
[units: participants]
 
Female     7  
Male     18  
Race/Ethnicity, Customized [3]
[units: participants]
 
Caucasian     23  
Black     1  
Other     1  
[1] Safety population.
[2] Safety population includes all subjects who received at least one dose of perampanel in this study.
[3] Race. Safety population.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline by Visit in Absolute OFF Time (Hours) During Open-label Extension Study   [ Time Frame: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56 ]

2.  Secondary:   Mean Change From Baseline by Visit in Absolute ON Time (Without Dyskinesias or With Nontroublesome Dyskinesias) (Hours) During Open-label Extension Study   [ Time Frame: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56 ]

3.  Secondary:   Mean Change From Baseline by Visit in UPDRS Part II (ADL) in OFF State (Hours) During Open-label Extension Study   [ Time Frame: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56 ]

4.  Secondary:   Mean Change From Baseline by Visit in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study   [ Time Frame: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56 ]


  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
Due to early termination, a limited number of subjects (n=26) were screened for inclusion in the study and only 25 subjects were analyzed. The majority of subjects did not reach the scheduled Week 56 assessment.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Eisai Inc.
Organization: Eisai Call Center
phone: 888-422-4743


No publications provided


Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00427011     History of Changes
Other Study ID Numbers: E2007-A001-220
Study First Received: January 24, 2007
Results First Received: November 20, 2012
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration