• PDTrials - Parkinson's Disease Clinical Trials
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Official Study Title: Methylphenidate for the Treatment of Gait  GaitWay of walking, which is diminished in people with Parkinson’s who tend to shuffle their feet, take too short steps, and not swing one or both arms. Impairment in Parkinson's Disease:  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. a Randomized Double-Blind,  Double-blindClinical study design in which neither investigators nor participants know who is receiving the investigational drug and who is receiving a placebo. Placebo-Controlled, Cross-Over Study
Sponsor: University of Cincinnati
Clinicaltrials.gov ID: NCT00526630
Study ID: 07-06-19-07

Summary

The purpose of this research study is to examine whether Methylphenidate (MPD) can result in improvement of gait (walking) in a population of people with Parkinson's disease (PD) whose main disability is freezing of gait. MPD, commonly known as Ritalin®, is a drug which can excite or stimulate certain systems of the body that control motor function. This drug is FDA approved for the treatment of attention hyperactivity disorder, a condition unrelated to PD. The researchers hypothesize that daily treatment with a tolerable daily oral dose of MPD will improve gait velocity, stride length, cadence, and decrease freezing of gait, three months from treatment initiation in participants with moderately advanced PD, whose gait impairment is an important source of disability despite optimized anti-parkinsonian treatment.

Study Phase

Phase 4
What is a study phase?

Symptoms Addressed: Movement Symptoms

Walking/Gait, Slowness of movement (bradykinesia)  BradykinesiaSlowness of movement. , Freeze Attacks  Freeze AttacksThe sudden loss of ability to move.

Time Commitment

• More than six months
• This study involves a total of six visits to the University of Cincinnati Movement disorder clinic during a 27 week period. Each study visit will last approximately 5-7 hours.

Eligibility

• Minimum Age: 35
• Maximum Age: 85
• Gender(s) Accepted: Either
• Minimum Years Since Diagnosis: 5

Inclusion Criteria

• Participants with a definite diagnosis of PD (not parkinsonism) for at least 5 years
• Participants with moderate to severe gait difficulties
• Participants on a stable dose of anti-parkinsonian medications that will not be expected to require medication adjustments

Exclusion Criteria

• People with musculoskeletal disorders such as severe arthritis, post knee surgery, hip surgery or any other condition that the investigators determine may impair assessment of gait
• Previous treatment with DBS (deep brain stimulation)  Deep Brain Stimulation (DBS)Procedure in which a small, surgically implanted, battery-operated medical device delivers electrical stimulation, and "turns-off" brain regions that produce Parkinson’s symptoms.
• People with history of stroke
• People with cerebellar, vestibular, or sensory ataxia (incoordination and/or unsteadiness)
• Concurrent use of, or within two weeks from discontinuing, MAO inhibitor drugs (selegiline,  SelegilineInhibitor that increases the amount of dopamine in the brain to help control the symptoms of Parkinson's in people who are taking levodopa and carbidopa in combination (Sinemet). Selegiline may help people with Parkinson's to decrease the dose of levodopa/carbidopa needed to control symptoms, stopping the effects of levodopa/carbidopa from wearing off between doses, and increasing the length of time that levodopa/carbidopa will continue to control symptoms. rasagiline)
• Women of childbearing potential

Enrollment

Expected Enrollment: 20 (US)
Date Enrollment Began: Sep 01 2007
Last Updated Date: Sep 21 2007
Trial Post Date: Sep 21 2007
Website: http://clinicaltrials.gov/ct/show/NCT00526630?order=2

Primary Contacts and Locations

Ohio

• Ms. Noël Burton, MA, PC
  University of Cincinnati
  noel.burton@uc.edu
  Phone: (513) 558-7019
  University Neurology
  Movement Disorders Clinic
  Cincinnati, OH 45219
  USA