Methylphenidate and Parkinson's Disease
Information source: National Institute of Neurological Disorders and Stroke (NINDS)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson's Disease
Intervention: methylphenidate (Drug)
Phase: Phase 2
Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)
Official(s) and/or principal investigator(s):
John G. Nutt, MD, Principal Investigator, Affiliation: Professor of Neurology, Oregon Health Science University
Julie H. Carter, ANP, Principal Investigator, Affiliation: Oregon Health and Science University
Nichole T. Carlson, PhD, Principal Investigator, Affiliation: Oregon Health and Science University
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).
Official title: Subacute Trial of Methylphenidate in Parkinson's Disease
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: Time "on" defined by tapping speed
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 narcolepsyâon
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).
Minimum age: 21 Years.
Maximum age: N/A.
- Idiopathic PD treated with levodopa and experiencing motor fluctuations
- At least 21 years of age
- Male or female.
- Cardiovascular disease, psychosis, extreme anxiety, dementia and other unstable
Locations and Contacts
Department of Neurology, OP-2, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, Oregon 97239, United States
Starting date: July 2004
Last updated: August 2, 2007