NCT01789047

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 30 Years – 90 Years
• Healthy volunteers: Not accepted

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 Parkinson's disease (PD) patients who continue to have dyskinesia on amantadine.

Detailed description

We conducted a randomized placebo controlled trial of topiramate in PD dyskinetic subjects already on amantadine but with continuing dyskinesia. Topiramate or placebo was introduced in blinded fashion with a gradual titration (topiramate 25-150 mg/d) over 6 weeks and then a maintenance period of 8 weeks. The primary outcome of interest was change from baseline to end of study in total Unified Dyskinesia Rating Scale (UDysRS) score using Intention to Treat analysis.

Conditions

• Idiopathic Parkinson's Disease
• Drug Induced Dyskinesia

Interventions

Type	Name	Description
DRUG	Topiramate	Topiramate as adjunct to amantadine
DRUG	Placebo	Placebo control
DRUG	Amantadine	Existing treatment for all participants

Timeline

• Start date: 2013-03-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2013-02-11
• Last updated: 2019-04-16
• Results posted: 2019-04-16

Locations

5 sites across 1 country: United States