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

Phase 3

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: placebo comparator; Drug: 2 mg perampanel; Drug: 4 mg perampanel

• Registration Number: NCT00368108
• Lead Sponsor: Eisai Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-22
• Study First Submitted QC: 2006-08-22
• Study First Posted: 2006-08-24
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Disposition First Submitted: 2012-08-23
• Disposition First Submitted QC: 2012-08-23
• Disposition First Posted: 2012-08-30
• Results First Submitted: 2012-10-23
• Status Verified: 2013-01
• Results First Submitted QC: 2013-01-02
• Results First Posted: 2013-02-05
• Last Update Submitted: 2013-05-13
• Last Update Posted: 2013-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 752

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo comparator	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.
2 mg perampanel	2 mg perampanel	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.
4 mg perampanel	4 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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Scale UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 20 (Including LOCF Data)	Baseline and Week 20	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.
Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 20 (Including LOCF Data)	Baseline and Week 20	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.
Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) to Week 20 (Including LOCF Data)	Baseline and Week 20	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.

Trial Locations

Locations (114)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

North Alabama Neuroscience Research Associates; 🇺🇸 Huntsville, Alabama, United States

Pivotal Research Centers; 🇺🇸 Peoria, Arizona, United States

Mayo Clinic Arizona; 🇺🇸 Scottsdale, Arizona, United States

Northwest NeuroSpecialists, PLLC; 🇺🇸 Tucson, Arizona, United States

Clinical Trials Inc.; 🇺🇸 Little Rock, Arkansas, United States

UAMS Department of Neurology; 🇺🇸 Little Rock, Arkansas, United States

The Parkinson's and Movement Disorder Institute; 🇺🇸 Fountain Valley, California, United States

Margolin Brain Institute; 🇺🇸 Fresno, California, United States

University of California Medical Center - Irvine; 🇺🇸 Irvine, California, United States

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