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

Completed · Phase 3 · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

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.

Key facts

Study ID

NCT00368108

Run by

Eisai Inc.

People needed

752

Starts

2006-08-01

Expected to finish

2008-01-01

Last updated by the study team

2013-05-20

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Patients must have been diagnosed with idiopathic PD at > 30 years of age.
• Patients must have predictable motor fluctuations of the wearing "OFF" type.
• Patients must rate between II-IV on the Hoehn \& Yahr scale when in an "OFF" state.
• Patients must be taking optimized levodopa therapy.

You may not qualify if…

• Pregnant or lactating women.
• 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.
• Patients with a past or present history of drug or alcohol abuse as per Diagnostic and Statistical Manual - 4th edition (DSM IV) criteria.
• Patients with a past (within one year) or present history of suicidal ideation or suicide attempts.
• 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.

Where it is running

• 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
• 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
• Loma Linda University — Loma Linda, California, United States
• University of Southern California — Los Angeles, California, United States
• Pacific Neuroscience Medical Group, Inc. — Oxnard, California, United States
• University of California San Francisco Medical Center — San Francisco, California, United States
• The Parkinson's Institute — Sunnyvale, California, United States
• Mile High Research Center — Denver, Colorado, United States
• University Of Colorado — Denver, Colorado, United States
• Colorado Neurology — Englewood, Colorado, United States
• Associated Neurologists, PC - Danbury — Danbury, Connecticut, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Molecular Neuroimaging, LLC — New Haven, Connecticut, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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