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Methylphenidate and Parkinson's Disease
This study has been completed.
Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT00359723
  Purpose

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

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease
MedlinePlus related topics: Parkinson's Disease
Drug Information available for: Methylphenidate hydrochloride Methylphenidate
U.S. FDA Resources
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

Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Primary Outcome Measures:
  • Time "on" defined by tapping speed

Estimated Enrollment: 24
Study Start Date: July 2004
Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359723

Locations
United States, Oregon
Department of Neurology, OP-2, Oregon Health & Science University, 3181 SW Sam Jackson Park Road
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Investigators
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
  More Information

Publications indexed to this study:
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

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
Parkinson's disease
PD
methylphenidate
Ritalin
MPD

Study placed in the following topic categories:
Dopamine
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
Methylphenidate
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009