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Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00359723 |
The purpose of this trial is to determine if methylphenidate (MPD), a drug marketed in the U.S. to treat hyperactivity and narcolepsy, added to levodopa, will increase the beneficial effects of levodopa without bothersome side effects in people with Parkinson's disease (PD).
Condition | Intervention | Phase |
---|---|---|
Parkinson's Disease |
Drug: methylphenidate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Subacute Trial of Methylphenidate in Parkinson's Disease |
Estimated Enrollment: | 24 |
Study Start Date: | July 2004 |
Parkinson's disease (PD) is a common disorder caused by the loss of dopamine-producing brain cells. The disorder is generally treated with levodopa combined with carbidopa. Nerve cells use levodopa to make dopamine. Carbidopa delays the conversion of levodopa into dopamine until it reaches the brain. Motor fluctuations (the wearing off effects of levodopa characterized by sometimes rapid changes between uncontrolled and normal movements) are a common, and often difficult to manage, source of disability in people with PD.
In this trial researchers will study the effects of methylphenidate (MPD), also known as Ritalin—a drug marketed in the U.S. to treat hyperactivity and narcolepsy—on carbidopa/levodopa and other antiparkinson medications taken orally by individuals with Parkinson's disease who experience motor fluctuations when they take levodopa. The overall goal of this project is to develop better symptomatic therapies for PD.
After 2 screening visits to the treatment clinic to evaluate the wearing "on" and "off" effects of levodopa, eligible participants will be scheduled for 3 admissions to the General Clinical Research Center at Oregon Health & Science University during which they randomly will receive the study drug, MPD, or placebo, along with their usual carbidopa/levodopa therapy and/or other antiparkinson medications. Also, participants will have their parkinsonism (tremor, rigidity, postural instability, and bradykinesia) rated and blood pressure and pulse measured at regular lintervals.
Duration of the study for participants is about 3 weeks and includes 2 outpatient clinic visits (for screening) and 3 inpatient clinic visits (with overnight stays).
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Oregon | |
Department of Neurology, OP-2, Oregon Health & Science University, 3181 SW Sam Jackson Park Road | |
Portland, Oregon, United States, 97239 |
Principal Investigator: | John G. Nutt, MD | Professor of Neurology, Oregon Health Science University |
Principal Investigator: | Julie H. Carter, ANP | Oregon Health and Science University |
Principal Investigator: | Nichole T. Carlson, PhD | Oregon Health and Science University |
Study ID Numbers: | R01NS21062 |
Study First Received: | July 31, 2006 |
Last Updated: | August 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00359723 |
Health Authority: | United States: Federal Government |
Parkinson's disease PD methylphenidate Ritalin MPD |
Dopamine Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases |
Methylphenidate Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Nervous System Diseases Central Nervous System Stimulants Dopamine Agents Central Nervous System Agents Pharmacologic Actions |