Idiopathic Parkinson's Disease Clinical Trial
— TOP-DYSKOfficial title:
Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease
NCT number | NCT01789047 |
Other study ID # | TOP-DYSK |
Secondary ID | |
Status | Terminated |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | March 2013 |
Est. completion date | July 2016 |
Verified date | March 2019 |
Source | Rush University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 42 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 90 Years |
Eligibility |
Inclusion Criteria: 1. Parkinson's disease patient, defined by United Kingdom (UK) Brain Bank criteria 2. Current age between 30-90 3. 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. * 4. Stable doses of all antiparkinsonian medications for at least 4 weeks 5. Stable treatment with at least 200 mg amantadine for at least 4 weeks. 6. Presence of a caregiver willing to participate in the study 7. 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. 8. Subjects must be free of dementia, depression and psychosis as determined by clinical examination. 9. The subject must be willing to participate in all study related activities and visits. Exclusion criteria: 1. Any subjects with clinical evidence suggestive of an atypical or secondary form of Parkinson's Disease 2. Any subject who, in the opinion of the Principal Investigator, has a concomitant medical illness which would preclude them from being treated with amantadine, 3. 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, 4. Any subject with evidence for dementia, depression, or psychosis, as determined by clinical examination. 5. Any subject who has not signed informed consent, or unable or unwilling to participate in all of the study related activities. |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama | Birmingham | Alabama |
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 | University of South Florida | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Rush University Medical Center | Michael J. Fox Foundation for Parkinson's Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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". | Assessed at Week 10 and 14 by blinded treating physician and subject | |
Other | 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 | Assessed at baseline, week 6, week 10 and week 14 | |
Other | Hoehn & Yahr Staging | Hoehn & Yahr staging of Parkinson's disease is completed by the blinded treating physician assessing the subject | Assessment completed at baseline, week 6, week 10 and week 14 | |
Primary | 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. | Change from baseline to week 14 (end of study) on the Unified Dyskinesia Rating Scale |
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