Methylphenidate and Parkinson's Disease

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00359723
First received: July 31, 2006
Last updated: September 3, 2009
Last verified: September 2009

July 31, 2006
September 3, 2009
July 2004
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Time "on" defined by tapping speed
Time “on” defined by tapping speed
Complete list of historical versions of study NCT00359723 on ClinicalTrials.gov Archive Site
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Methylphenidate and Parkinson's Disease
Subacute Trial of Methylphenidate in Parkinson's Disease

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).

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Parkinson's Disease
Drug: methylphenidate
Not Provided
Nutt JG, Carter JH, Carlson NE. Effects of methylphenidate on response to oral levodopa: a double-blind clinical trial. Arch Neurol. 2007 Mar;64(3):319-23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
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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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00359723
R01NS21062
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Oregon Health and Science University
National Institute of Neurological Disorders and Stroke (NINDS)
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
Oregon Health and Science University
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP