Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy (STRIDE-PD)
Parkinson's Disease
About this trial
This is an interventional prevention trial for Parkinson's Disease focused on measuring Parkinson's disease, levodopa therapy, dyskinesia
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of idiopathic Parkinson's disease Diagnosis of Parkinson's disease for no more than 5 years Exclusion Criteria: History, signs, or symptoms of atypical or secondary parkinsonism Presence at baseline of drug-related wearing-off symptoms, dyskinesia or other motor complications Levodopa exposure of more than 30 days or anytime within 8 weeks prior to visit 1 Other inclusion/exclusion criteria applied to this study.
Sites / Locations
- University of Alabama at Birmingham
- Mayo Clinic
- Coastal Neurological Medical Group
- Keck School of Medicine, Division of Movement Disorders
- Reed Neurological Research Center
- The Parkinson's Institute
- Molecular NeuroImaging, LLC
- Parkinson's Disease and Movement Disorder Center
- University of Miami
- Charlotte Neurological Service
- University of South Florida
- Wesley Woods Health Center
- Medical College of Georgia
- Northwestern University Medical School
- Rush University Medical Center
- Landon Center on Aging
- Ochsner Clinic Foundation
- Boston University School of Medicine
- Clinical Neuroscience Center
- Parkinson's Disease and Movement Disorder Center of Albany Medical
- Parkinson's Disease and Movement Disorders Center of Long Island
- Mount Sinai School of Medicine
- Columbia University, Neurological Institute
- University of Rochester
- Duke University Medical Center Movement Disorders Center
- Pennsylvania Neurology Institute
- NeuroHealth, Inc.
- Semmes-Murphey Clinic
- University of Texas Southwestern Medical Center at Dallas
- Baylor College of Medicine, Parkinson's Disease Center
- Wisconsin Institute for Neurologic and Sleep Disorders
- Novartis Investigative Site
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Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Carbidopa/levodopa/entacapone
Immediate release carbidopa/levodopa
Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.