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

History of Changes

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

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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 ]

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Measure Type	Primary
Measure Title	Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data)
Measure Description	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
Safety Issue	No

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.
The Intent-to-treat (ITT) Population for diary data consisted of all subjects who were randomized to either perampanel or placebo, had taken at least 1 dose, had a valid, nonmissing Baseline diary measurement and at least 1 valid, non-missing, postbaseline diary measurement at Last Observation Carried Forward (LOCF).

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.

Measured Values

	Placebo	Perampanel 2mg	Perampanel 4mg
Number of Participants Analyzed [units: participants]	208	213	201
Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data) [units: Hours] Least Squares Mean ( 95% Confidence Interval )	-0.96 ( -1.42 to -0.51 )	-0.93 ( -1.38 to -0.49 )	-0.76 ( -1.20 to -0.31 )

No statistical analysis provided for Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data)

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 ]

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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 ]

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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 ]

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Serious Adverse Events

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Other Adverse Events

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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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