Methylphenidate and Parkinson's Disease

This study has been completed.

Sponsor:

Collaborator:

National Institute of Neurological Disorders and Stroke (NINDS)

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

History of Changes

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 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Subacute Trial of Methylphenidate in Parkinson's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

National Institute of Neurological Disorders and Stroke (NINDS)

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 ClinicalTrials.gov Identifier (NCT Number):

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.


ClinicalTrials.gov Identifier:	NCT00359723 History of Changes
Other Study ID Numbers:	R01NS21062
Study First Received:	July 31, 2006
Last Updated:	September 3, 2009
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:


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

ClinicalTrials.gov processed this record on March 01, 2015

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