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Methylphenidate and Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT00359723
Recruitment Status : Completed
First Posted : August 2, 2006
Last Update Posted : November 29, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
John G. Nutt, Oregon Health and Science University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Parkinson's Disease Drug: methylphenidate Phase 2

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Subacute Trial of Methylphenidate in Parkinson's Disease
Study Start Date : July 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Methylphenidate 0.4 mg/kg TID followed by placebo TID
As above
 Drug: methylphenidate
Experimental: Placebo TID followed by methylphenidate 0.4 mg/kg TID
As above
 Drug: methylphenidate


Outcome Measures
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Primary Outcome Measures :
  1. Time "on" defined by tapping speed

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Locations
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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
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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
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Publications of Results:

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Responsible Party: John G. Nutt, Professor of Neurology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00359723    
Other Study ID Numbers: IRB00000959
R01NS021062 ( U.S. NIH Grant/Contract )
First Posted: August 2, 2006    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Keywords provided by John G. Nutt, Oregon Health and Science University:
Parkinson's disease
PD
methylphenidate
Ritalin
MPD
Additional relevant MeSH terms:
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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