Skip to main content
OpenTrials
Completed

NCT Number: NCT00359723

Methylphenidate and 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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Neurology, OP-2, Oregon Health & Science University, 3181 SW Sam Jackson Park Road

Portland, Oregon, 97239, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Methylphenidate

Drug

Primary outcomes

  1. Time "on" defined by tapping speed

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Subacute Trial of Methylphenidate in Parkinson's Disease

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Aug 2, 2006
Registry last updated
Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.