Methylphenidate and Parkinson's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00359723|
Recruitment Status : Completed
First Posted : August 2, 2006
Last Update Posted : November 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: methylphenidate||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Experimental: Methylphenidate 0.4 mg/kg TID followed by placebo TID
Experimental: Placebo TID followed by methylphenidate 0.4 mg/kg TID
- Time "on" defined by tapping speed
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
|United States, Oregon|
|Department of Neurology, OP-2, Oregon Health & Science University, 3181 SW Sam Jackson Park Road|
|Portland, Oregon, United States, 97239|
|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|