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Methylphenidate and Parkinson's Disease
This study has been completed.
First Received: July 31, 2006   Last Updated: September 3, 2009   History of Changes
Sponsor: Oregon Health and Science University
Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: Oregon Health and Science University
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

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

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

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 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).

  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
Oregon Health and Science University
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

No publications provided by Oregon Health and Science University

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: R01NS21062
Study First Received: July 31, 2006
Last Updated: September 3, 2009
ClinicalTrials.gov Identifier: NCT00359723     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Oregon Health and Science University:
Parkinson's disease
PD
methylphenidate
Ritalin
MPD

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Central Nervous System Diseases
Methylphenidate
Central Nervous System Stimulants
Brain Diseases
Neurodegenerative Diseases
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010