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

Idiopathic Parkinson's Disease Clinical Trial

— TOP-DYSK  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01789047
• Other study ID #: TOP-DYSK
• Status: Terminated
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Drug Induced Dyskinesia
• Dyskinesia, Drug-Induced
• Dyskinesias
• Idiopathic Parkinson's Disease
• Parkinson Disease

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