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

Parkinson's Disease Clinical Trial

Official title:

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00368108
• Other study ID #: E2007-A001-302
• Status: Completed
• Phase: Phase 3
• First received: August 22, 2006
• Last updated: May 13, 2013
• Start date: August 2006
• Est. completion date: January 2008

Study information

• Verified date: January 2013
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 752
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

INCLUSION CRITERIA:

1. Male or female patients with idiopathic Parkinson's Disease fulfilling the United Kingdom (UK) Parkinson's disease Society Brain Bank diagnostic criteria 7, with a good response to levodopa.

2. Patients must have been diagnosed with idiopathic PD at > 30 years of age.

3. Patients must have predictable motor fluctuations of the wearing "OFF" type.

4. Patients must rate between II-IV on the Hoehn & Yahr scale when in an "OFF" state.

5. Patients must be taking optimized levodopa therapy.

EXCLUSION CRITERIA:

1. Pregnant or lactating women.

2. Women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (eg, abstinence, intrauterine device or barrier method plus hormonal method). These patients must have a negative serum beta-human chorionic gonadotrophin (B-HCG) test at the Screening visit, and a negative urine pregnancy test at the Baseline visit (Day 0). These patients must also be willing to remain on their current form of contraception for the duration of the study. Postmenopausal women may be recruited but must be amenorrheic for at least one year to be considered of non-child bearing potential as determined by the Investigator.

3. Patients with a past or present history of drug or alcohol abuse as per Diagnostic and Statistical Manual - 4th edition (DSM IV) criteria.

4. Patients with a past (within one year) or present history of suicidal ideation or suicide attempts.

5. Patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastro-intestinal, hematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• 2 mg perampanel
2 mg perampanel
• 4 mg perampanel
4 mg perampanel
• placebo comparator
placebo comparator

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Clinique Neuro Rive-Sud	Greenfield Park	Quebec
Canada	David King, MD	Halifax	Nova Scotia
Canada	Centre For Movement Disorders	Markham	Ontario
Canada	CHUM- Hotel-Dieu	Montreal	Quebec
Canada	Montreal General Hospital	Montreal	Quebec
Canada	SMBD Jewish General Hospital	Montreal	Quebec
Canada	Parkinson's and Neurodegenerative Disorders Clinic	Ottawa	Ontario
Canada	The Ottawa Hospital - Civic Campus	Ottawa	Ontario
Canada	Quebec Memory and Motor Skills Disorders Clinic	Quebec
Canada	Saint John Regional Hospital, 5DN	Saint John	New Brunswick
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Torotnto Western Hospital-University Health Network	Toronto	Ontario
Canada	Pacific Parkinson Research Centre	Vancouver	British Columbia
United States	Albany Medical College	Albany	New York
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Asheville Neurology Specialists	Asheville	North Carolina
United States	Asheville Neurology Specialists. PA	Asheville	North Carolina
United States	Emory University	Atlanta	Georgia
United States	Medical College of Georgia	Augusta	Georgia
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Quest Research Institute	Bingham Farms	Michigan
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Parkinson's Disease and Movement Disorder Center of Boca Raton	Boca Raton	Florida
United States	Boston University Medical Center	Boston	Massachusetts
United States	Harvard Vanguard Medical Associates	Boston	Massachusetts
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	Capitol Neurology	Charleston	West Virginia
United States	Northwestern University Medical School	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Parkinson's Disease and Movement Disorder Center of Long Island	Commack	New York
United States	Radiant Research - Dallas North	Dallas	Texas
United States	Associated Neurologists, PC - Danbury	Danbury	Connecticut
United States	Neurology Specialists, Inc.	Dayton	Ohio
United States	Dekalb Neurology Associates, LLC/DNA Research	Decatur	Georgia
United States	Brain Matters Research	Delray Beach	Florida
United States	Mile High Research Center	Denver	Colorado
United States	University Of Colorado	Denver	Colorado
United States	Duke University	Durham	North Carolina
United States	Parkinson's and Movement Disorders Center of Maryland	Elkridge	Maryland
United States	Colorado Neurology	Englewood	Colorado
United States	New York University Medical Center	Forest Hills	New York
United States	Fort Wayne Neurological Center	Fort Wayne	Indiana
United States	The Parkinson's and Movement Disorder Institute	Fountain Valley	California
United States	Margolin Brain Institute	Fresno	California
United States	University of Florida	Gainesville	Florida
United States	Struthers Parkinson's Center	Golden Valley	Minnesota
United States	Hartford Hospital	Hartford	Connecticut
United States	Sunrise Clinical Research	Hollywood	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	North Alabama Neuroscience Research Associates	Huntsville	Alabama
United States	Indiana University	Indianapolis	Indiana
United States	University Of Iowa	Iowa City	Iowa
United States	University of California Medical Center - Irvine	Irvine	California
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	University of Florida - Department of Neurology	Jacksonville	Florida
United States	University of Kansas	Kansas City	Kansas
United States	Coastal Neurological Group	La Jolla	California
United States	Scripps Clinic	La Jolla	California
United States	University of California at San Diego - Department of Neurology	La Jolla	California
United States	University of Nevada School of Medicine	Las Vegas	Nevada
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University Of Kentucky	Lexington	Kentucky
United States	Clinical Trials Inc.	Little Rock	Arkansas
United States	UAMS Department of Neurology	Little Rock	Arkansas
United States	Loma Linda University	Loma Linda	California
United States	University of Southern California	Los Angeles	California
United States	Kentucky Neuroscience Research	Louisville	Kentucky
United States	Agape' Medical Center, Inc.	Lubbock	Texas
United States	Bhupesh Dihenia, MD, PA	Lubbock	Texas
United States	North Shore Medical Center	Manhasset	New York
United States	Semmes Murphey Neurology and Spine Institute	Memphis	Tennessee
United States	Miami Research Associates	Miami	Florida
United States	University of Miami	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Wisconsin Institute for Neurologic and Sleep Disorders	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	University of Medicine and Dentistry of New Jersey	New Brunswick	New Jersey
United States	Molecular Neuroimaging, LLC	New Haven	Connecticut
United States	Columbia University	New York	New York
United States	Columbia University Medical Center	New York	New York
United States	The Mount Sinai Medical Center	New York	New York
United States	University of Oklahoma - Health Sciences Center	Oklahoma City	Oklahoma
United States	Creighton University - Department of Neurology	Omaha	Nebraska
United States	Pacific Neuroscience Medical Group, Inc.	Oxnard	California
United States	Palm Beach Neurological Center	Palm Beach Gardens	Florida
United States	OSF Saint Francis Medical Center	Peoria	Illinois
United States	Pivotal Research Centers	Peoria	Arizona
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Gil, Ramon A.	Port Charlotte	Florida
United States	Raleigh Neurology Associates, P.A.	Raleigh	North Carolina
United States	Hunter Holmes McGuire	Richmond	Virginia
United States	University of Rochester - Neurology Clinic	Rochester	New York
United States	Neurology Associates	San Antonio	Texas
United States	University of California San Francisco Medical Center	San Francisco	California
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	LSUHSC-Shreveport	Shreveport	Louisiana
United States	The Clinical Neurosciences Center	Southfield	Michigan
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	Washington University	St. Louis	Missouri
United States	Suncoast Neuroscience Associates, Inc.	St. Petersburg	Florida
United States	The Parkinson's Institute	Sunnyvale	California
United States	Neurology and Neurosurgery Associates of Tacoma, PLLC	Tacoma	Washington
United States	University Of South Florida Movement Disorders Clinic	Tampa	Florida
United States	The University of Toledo College of Medicine	Toledo	Ohio
United States	Northern Michigan Neurology	Traverse City	Michigan
United States	Northwest NeuroSpecialists, PLLC	Tucson	Arizona
United States	Crozer Medical Center	Upland	Pennsylvania
United States	Georgetown University Hospital	Washington	District of Columbia
United States	Cleveland Clinic Florida - Weston	Weston	Florida
United States	Lankenau Hospital	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data)	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.	Baseline and Week 20	No
Secondary	Mean Change From Baseline in Scale UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 20 (Including LOCF Data)	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.	Baseline and Week 20	No
Secondary	Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 20 (Including LOCF Data)	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.	Baseline and Week 20	No
Secondary	Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) to Week 20 (Including LOCF Data)	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.	Baseline and Week 20	No