Methylphenidate and Parkinson's Disease
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ClinicalTrials.gov Identifier: NCT00359723 |
Recruitment Status
:
Completed
First Posted
: August 2, 2006
Last Update Posted
: September 4, 2009
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson's Disease | Drug: methylphenidate | Phase 2 |
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 intervals.
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).
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Subacute Trial of Methylphenidate in Parkinson's Disease |
Study Start Date : | July 2004 |

- Time "on" defined by tapping speed

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Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Idiopathic PD treated with levodopa and experiencing motor fluctuations
- At least 21 years of age
- Male or female.
Exclusion Criteria:
- Cardiovascular disease, psychosis, extreme anxiety, dementia and other unstable medical conditions.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359723
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00359723 History of Changes |
Other Study ID Numbers: |
R01NS021062 ( U.S. NIH Grant/Contract ) |
First Posted: | August 2, 2006 Key Record Dates |
Last Update Posted: | September 4, 2009 |
Last Verified: | September 2009 |
Keywords provided by Oregon Health and Science University:
Parkinson's disease PD methylphenidate Ritalin MPD |
Additional relevant MeSH terms:
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Methylphenidate |
Central Nervous System Stimulants Physiological Effects of Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents |