Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Parkinson's Disease, Drug Induced Dyskinesia

In brief

The study will involve an eighteen-week, double-blind, placebo-controlled parallel designed comparison between add-on topiramate and add-on placebo to stable treatment with amatadine in the treatment of Parkinson's disease (PD) patients who continue to have dyskinesia on amantadine.

Key facts

Study ID

NCT01789047

Run by

Rush University Medical Center

People needed

42

Starts

2013-03-01

Expected to finish

2016-07-01

Last updated by the study team

2019-04-16

Who can join

Age: 30 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Parkinson's disease patient, defined by United Kingdom (UK) Brain Bank criteria
• Current age between 30-90
• Clinically pertinent dyskinesias defined by Clinical Global Impression - Severity (CGI-s) score (see attachment) > 3 (mild) established by clinician's total assessment of patient including objective observation during the screening process. *
• Stable doses of all antiparkinsonian medications for at least 4 weeks
• Stable treatment with at least 200 mg amantadine for at least 4 weeks.
• Presence of a caregiver willing to participate in the study
• In the opinion of the enrolling investigator, the subject will be able to maintain current dosing schedule of antiparkinsonian drugs for the duration of the trial.
• Subjects must be free of dementia, depression and psychosis as determined by clinical examination.
• The subject must be willing to participate in all study related activities and visits.

You may not qualify if…

• Any subjects with clinical evidence suggestive of an atypical or secondary form of Parkinson's Disease
• Any subject who, in the opinion of the Principal Investigator, has a concomitant medical illness which would preclude them from being treated with amantadine,
• Any subject who, in the opinion of the Principal Investigator, will be unable to maintain current stable dosing of their anti-parkinsonian medications for the duration of the trial,
• Any subject with evidence for dementia, depression, or psychosis, as determined by clinical examination.
• Any subject who has not signed informed consent, or unable or unwilling to participate in all of the study related activities.

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• University of South Florida — Tampa, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Duke University — Durham, North Carolina, United States
• Oregon Health Sciences University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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