Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations
Parkinson's Disease
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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.
Sites / Locations
- University of Alabama at Birmingham
- North Alabama Neuroscience Research Associates
- Pivotal Research Centers
- Mayo Clinic Arizona
- Northwest NeuroSpecialists, PLLC
- Clinical Trials Inc.
- UAMS Department of Neurology
- The Parkinson's and Movement Disorder Institute
- Margolin Brain Institute
- University of California Medical Center - Irvine
- Coastal Neurological Group
- Scripps Clinic
- University of California at San Diego - Department of Neurology
- Loma Linda University
- University of Southern California
- Pacific Neuroscience Medical Group, Inc.
- University of California San Francisco Medical Center
- The Parkinson's Institute
- Mile High Research Center
- University Of Colorado
- Colorado Neurology
- Associated Neurologists, PC - Danbury
- Hartford Hospital
- Molecular Neuroimaging, LLC
- Georgetown University Hospital
- Parkinson's Disease and Movement Disorder Center of Boca Raton
- Brain Matters Research
- University of Florida
- Sunrise Clinical Research
- University of Florida - Department of Neurology
- Mayo Clinic Jacksonville
- University of Miami
- Miami Research Associates
- Palm Beach Neurological Center
- Gil, Ramon A.
- Suncoast Neuroscience Associates, Inc.
- University Of South Florida Movement Disorders Clinic
- Cleveland Clinic Florida - Weston
- Emory University
- Medical College of Georgia
- Dekalb Neurology Associates, LLC/DNA Research
- Northwestern University Medical School
- Rush University Medical Center
- OSF Saint Francis Medical Center
- Southern Illinois University School of Medicine
- Fort Wayne Neurological Center
- Indiana University
- University Of Iowa
- University of Kansas
- University Of Kentucky
- Kentucky Neuroscience Research
- LSUHSC-Shreveport
- University of Maryland Medical Center
- Parkinson's and Movement Disorders Center of Maryland
- Boston University Medical Center
- Harvard Vanguard Medical Associates
- Quest Research Institute
- The Clinical Neurosciences Center
- Northern Michigan Neurology
- Struthers Parkinson's Center
- University of Minnesota
- Washington University
- Creighton University - Department of Neurology
- University of Nevada School of Medicine
- Dartmouth-Hitchcock Medical Center
- University of Medicine and Dentistry of New Jersey
- Albany Medical College
- Parkinson's Disease and Movement Disorder Center of Long Island
- New York University Medical Center
- North Shore Medical Center
- The Mount Sinai Medical Center
- Columbia University Medical Center
- Columbia University
- University of Rochester - Neurology Clinic
- Asheville Neurology Specialists. PA
- Asheville Neurology Specialists
- Duke University
- Raleigh Neurology Associates, P.A.
- Ohio State University Medical Center
- Neurology Specialists, Inc.
- The University of Toledo College of Medicine
- University of Oklahoma - Health Sciences Center
- Lehigh Valley Hospital
- Pennsylvania Hospital
- Thomas Jefferson University
- Crozer Medical Center
- Lankenau Hospital
- Semmes Murphey Neurology and Spine Institute
- Radiant Research - Dallas North
- Baylor College of Medicine
- Agape' Medical Center, Inc.
- Bhupesh Dihenia, MD, PA
- Neurology Associates
- Fletcher Allen Health Care
- Hunter Holmes McGuire
- Neurology and Neurosurgery Associates of Tacoma, PLLC
- Capitol Neurology
- Medical College of Wisconsin
- Wisconsin Institute for Neurologic and Sleep Disorders
- University of Calgary
- University of Alberta
- Pacific Parkinson Research Centre
- Saint John Regional Hospital, 5DN
- David King, MD
- Centre For Movement Disorders
- Parkinson's and Neurodegenerative Disorders Clinic
- The Ottawa Hospital - Civic Campus
- Torotnto Western Hospital-University Health Network
- Clinique Neuro Rive-Sud
- CHUM- Hotel-Dieu
- Montreal General Hospital
- SMBD Jewish General Hospital
- Royal University Hospital
- Quebec Memory and Motor Skills Disorders Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
2 mg perampanel
4 mg perampanel
placebo
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.
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.
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.