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NCT01789047 · ClinicalTrials.gov registry record · Phase 2
Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease
A Phase 2 study, sponsored by Rush University Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT01789047: Clinical Trial Phase 2 study, sponsored by Rush University Medical Center.
NCT01789047 is a Phase 2 study that was terminated before completion, run by Rush University Medical Center. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01789047, a Phase 2 study, was terminated before completion, sponsored by Rush University Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study 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.
Primary Outcome
The Unified Dyskinesia Rating Scale (UDysRS) will be the primary outcome measure for this study. This choice is based on the outcome of the 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
Interventions
- DRUG Placebo
- DRUG Amantadine
- DRUG Topiramate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2013-03 |
| Est. Completion | 2016-07 |
| Phase | Phase 2 |
Why NCT01789047 stopped before completion
NCT01789047 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01789047 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01789047 about?
NCT01789047 is a clinical study titled "Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease". 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.
What is the current status of trial NCT01789047?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2013-03. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01789047?
The interventions under investigation include: Placebo (DRUG), Amantadine (DRUG), Topiramate (DRUG).
Who is sponsoring clinical trial NCT01789047?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01789047's enrollment target sits among peer trials
42 1339th of 2000 higher than 649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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