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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary: 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 PD patients who continue to have dyskinesia on amantadine.

Detailed Summary:
Sponsor: Rush University Medical Center

Current Primary Outcome: The Unified Dyskinesia Rating Scale (UDysRS) [ Time Frame: Baseline, Week 10 and week 14 performed by blinded rater ]

The Unified Dyskinesia Rating Scale (UDysRS) will be the primary outcome measure for this study. This choice is based on the outcome of the MJFF-funded Validation of Dyskinesia Rating Scales study. In this study, the UDysRS was identified as the most sensitive scale to detect change in dyskinesia in an 8-week, double-blind, placebo-controlled trial of amatadine. The UDysRS utilizes rater information, patient self-report and objective measures of dyskinesia to provide assessments of impairment and disability due to dyskinesia.


Original Primary Outcome: Same as current

Current Secondary Outcome: Clinical Global Impression - Change score [ Time Frame: Assessed at Week 10 and 14 by blinded treating physician and subject ]

Original Secondary Outcome: Same as current

Information By: Rush University Medical Center

Dates:
Date Received: February 7, 2013
Date Started: March 2013
Date Completion:
Last Updated: November 4, 2016
Last Verified: November 2016