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Clinical Trial Details — Status: Terminated

Administrative data

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

Study information

Verified date March 2019
Source Rush University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
Topiramate
Topiramate as adjunct to amantadine
Placebo
Placebo control
Amantadine
Existing treatment for all participants

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Rush University Medical Center Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

United States, 

Outcome

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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