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
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
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
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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.
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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.
Total Total of all reporting groups

Baseline Measures
    Placebo     Perampanel 2mg     Perampanel 4mg     Total  
Number of Participants  
[units: participants]
  250     251     250     751  
Age, Customized  
[units: Participants]
       
<65 years     149     144     147     440  
≥ 65 years     101     107     103     311  
Gender  
[units: participants]
       
Female     86     87     86     259  
Male     164     164     164     492  
Race/Ethnicity, Customized  
[units: Participants]
       
White     233     239     240     712  
Black     4     2     1     7  
Asian     5     4     1     10  
Other     8     6     8     22  



  Outcome Measures
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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
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Time Frame From the time the subject signed the informed consent form to 30 days after the last dose of the study drug.
Additional Description Adverse events were assessed at clinical visits based on the subject's diary, vitals, weight, physical examination, neurological exam, and laboratory evaluations.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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.

Other Adverse Events
    Placebo     Perampanel 2mg     Perampanel 4mg  
Total, other (not including serious) adverse events        
# participants affected / at risk     111/250     110/251     144/250  
Gastrointestinal disorders        
Nausea † 1      
# participants affected / at risk     16/250 (6.40%)     11/251 (4.38%)     12/250 (4.80%)  
Infections and infestations        
Urinary Tract Infection † 1      
# participants affected / at risk     10/250 (4.00%)     11/251 (4.38%)     13/250 (5.20%)  
Injury, poisoning and procedural complications        
Fall † 1      
# participants affected / at risk     23/250 (9.20%)     23/251 (9.16%)     19/250 (7.60%)  
Musculoskeletal and connective tissue disorders        
Back Pain † 1      
# participants affected / at risk     7/250 (2.80%)     16/251 (6.37%)     12/250 (4.80%)  
Nervous system disorders        
Balance Disorder † 1      
# participants affected / at risk     3/250 (1.20%)     6/251 (2.39%)     17/250 (6.80%)  
Dizziness † 1      
# participants affected / at risk     14/250 (5.60%)     15/251 (5.98%)     29/250 (11.60%)  
Dyskinesia † 1      
# participants affected / at risk     39/250 (15.60%)     21/251 (8.37%)     43/250 (17.20%)  
Headache † 1      
# participants affected / at risk     18/250 (7.20%)     10/251 (3.98%)     12/250 (4.80%)  
ON and OFF phenomenon † 1      
# participants affected / at risk     24/250 (9.60%)     18/251 (7.17%)     21/250 (8.40%)  
Somnolence † 1      
# participants affected / at risk     13/250 (5.20%)     32/251 (12.75%)     40/250 (16.00%)  
Psychiatric disorders        
Insomnia † 1      
# participants affected / at risk     15/250 (6.00%)     14/251 (5.58%)     15/250 (6.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA V. 10.1



  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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