A Phase 2 interventional study of Topiramate and Placebo in Idiopathic Parkinson's Disease and Drug Induced Dyskinesia, sponsored by Rush University Medical Center. Terminated at 5 sites in United States. Open to participants aged 30 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by Rush University Medical Center · Phase 2, Interventional, and Treatment
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.
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.
This study's enrollment of 42 is close to the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.
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Exclusion criteria:
Topiramate as adjunct to amantadine.
Drug: Topiramate · Drug: Amantadine
Placebo
Drug: Placebo · Drug: Amantadine
Topiramate as adjunct to amantadine
Also known as: Topamax
Placebo control
Also known as: sugar pill
Existing treatment for all participants
Also known as: Symmetrel
The Unified Dyskinesia Rating Scale (UDysRS)
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 due to dyskinesia. Score ranges are 0-108 with higher scores representing more severe impairment.
Time frame: Change from baseline to week 14 (end of study) on the Unified Dyskinesia Rating Scale
Clinical Global Impression - Change Score
The Clinical Global Impression - Change score is an ordinal measure of change with a range of 0 (not assessed) to 7 (very much worse). A score of 4 is associated with "no change".
Time frame: Assessed at Week 10 and 14 by blinded treating physician and subject
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
This is a 4-part scale that rates both non-motor and motor (including dyskinesia) aspects of Parkinson's disease. Parts of the scales will be completed by the blinded treating physician while assessing the subject and other parts will be self-completed by the subject
Time frame: Assessed at baseline, week 6, week 10 and week 14
Hoehn & Yahr Staging
Hoehn \& Yahr staging of Parkinson's disease is completed by the blinded treating physician assessing the subject
Time frame: Assessment completed at baseline, week 6, week 10 and week 14
| Milestone | Topiramate | Placebo (Sugar Pill) |
|---|---|---|
| Started | 21 | 21 |
| Completed | 17 | 17 |
| Not completed | 4 | 4 |
| Withdrew: Adverse event | 3 | 2 |
| Withdrew: Withdrawal by subject | 1 | 2 |
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 due to dyskinesia. Score ranges are 0-108 with higher scores representing more severe impairment.
| units on a scale | Topiramate | Placebo (Sugar Pill) |
|---|---|---|
| The Unified Dyskinesia Rating Scale (UDysRS) | 4.00 ± 11.34 | 1.67 ± 10.27 |
The Clinical Global Impression - Change score is an ordinal measure of change with a range of 0 (not assessed) to 7 (very much worse). A score of 4 is associated with "no change".
Results for this outcome have not been posted.
This is a 4-part scale that rates both non-motor and motor (including dyskinesia) aspects of Parkinson's disease. Parts of the scales will be completed by the blinded treating physician while assessing the subject and other parts will be self-completed by the subject
Results for this outcome have not been posted.
Hoehn \& Yahr staging of Parkinson's disease is completed by the blinded treating physician assessing the subject
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Topiramate | 0/21 (0%) | 2/21 (9.5%) | 16/21 (76.2%) |
| Placebo (Sugar Pill) | 0/21 (0%) | 0/21 (0%) | 12/21 (57.1%) |
| Event | Topiramate | Placebo (Sugar Pill) |
|---|---|---|
| Transit Ischemic Attack-like symptomsNervous system disorders | 1/21 | 0/21 |
| Fall leading to hospitalizationInjury, poisoning and procedural complications | 1/21 | 0/21 |
| Event | Topiramate | Placebo (Sugar Pill) |
|---|---|---|
| Blurred visionEye disorders | 3/21 | 1/21 |
| Increased OFF timeNervous system disorders | 2/21 | 3/21 |
| Weight lossMetabolism and nutrition disorders | 3/21 | 0/21 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/21 | 0/21 |
| Decreased appetiteGastrointestinal disorders | 2/21 | 0/21 |
| DizzinessNervous system disorders | 2/21 | 1/21 |
| Dry mouthGeneral disorders | 1/21 | 2/21 |
| FallsGeneral disorders | 2/21 | 1/21 |
| HallucinationsPsychiatric disorders | 2/21 | 2/21 |
| Sinus infectionInfections and infestations | 1/21 | 2/21 |
| Age, Continuous(years) | Topiramate | Placebo (Sugar Pill) | Total |
|---|---|---|---|
| Mean | 61.5 ± 6.9 | 63.1 ± 8.9 | 62.7 ± 7.4 |
| Sex: Female, Male(Participants) | Topiramate | Placebo (Sugar Pill) | Total |
|---|---|---|---|
| Female | 6 | 9 | 15 |
| Male | 15 | 12 | 27 |
| Region of Enrollment(Participants) | Topiramate | Placebo (Sugar Pill) | Total |
|---|---|---|---|
| United States | 21 | 21 | 42 |
This study is terminated, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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