Back to resultsTopiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease (TOP-DYSK)
Primary Purpose
Idiopathic Parkinson's Disease, Drug Induced Dyskinesia
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Topiramate
Placebo
Amantadine
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Parkinson's Disease focused on measuring Parkinson's disease, dyskinesia, Indonesia, amantadine
Eligibility Criteria
Inclusion Criteria:
- Parkinson's disease patient, defined by United Kingdom (UK) Brain Bank criteria
- Current age between 30-90
- 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. *
- Stable doses of all antiparkinsonian medications for at least 4 weeks
- Stable treatment with at least 200 mg amantadine for at least 4 weeks.
- Presence of a caregiver willing to participate in the study
- 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.
- Subjects must be free of dementia, depression and psychosis as determined by clinical examination.
- The subject must be willing to participate in all study related activities and visits.
Exclusion criteria:
- Any subjects with clinical evidence suggestive of an atypical or secondary form of Parkinson's Disease
- Any subject who, in the opinion of the Principal Investigator, has a concomitant medical illness which would preclude them from being treated with amantadine,
- 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,
- Any subject with evidence for dementia, depression, or psychosis, as determined by clinical examination.
- Any subject who has not signed informed consent, or unable or unwilling to participate in all of the study related activities.
Sites / Locations
- University of Alabama
- University of South Florida
- Rush University Medical Center
- Duke University
- Oregon Health Sciences University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Topiramate
Placebo (sugar pill)
Arm Description
Topiramate as adjunct to amantadine.
Placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01789047
First Posted
February 7, 2013
Last Updated
March 25, 2019
Sponsor
Rush University Medical Center
Collaborators
Michael J. Fox Foundation for Parkinson's Research
1. Study Identification
Unique Protocol Identification Number
NCT01789047
Brief Title
Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease
Acronym
TOP-DYSK
Official Title
Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Sponsor withdrew support
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
Collaborators
Michael J. Fox Foundation for Parkinson's Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson's Disease, Drug Induced Dyskinesia
Keywords
Parkinson's disease, dyskinesia, Indonesia, amantadine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topiramate
Arm Type
Active Comparator
Arm Description
Topiramate as adjunct to amantadine.
Arm Title
Placebo (sugar pill)
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Topiramate
Other Intervention Name(s)
Topamax
Intervention Description
Topiramate as adjunct to amantadine
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sugar pill
Intervention Description
Placebo control
Intervention Type
Drug
Intervention Name(s)
Amantadine
Other Intervention Name(s)
Symmetrel
Intervention Description
Existing treatment for all participants
Primary Outcome Measure Information:
Title
The Unified Dyskinesia Rating Scale (UDysRS)
Description
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
Other Pre-specified Outcome Measures:
Title
Clinical Global Impression - Change Score
Description
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
Title
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Description
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
Title
Hoehn & Yahr Staging
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parkinson's disease patient, defined by United Kingdom (UK) Brain Bank criteria
Current age between 30-90
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. *
Stable doses of all antiparkinsonian medications for at least 4 weeks
Stable treatment with at least 200 mg amantadine for at least 4 weeks.
Presence of a caregiver willing to participate in the study
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.
Subjects must be free of dementia, depression and psychosis as determined by clinical examination.
The subject must be willing to participate in all study related activities and visits.
Exclusion criteria:
Any subjects with clinical evidence suggestive of an atypical or secondary form of Parkinson's Disease
Any subject who, in the opinion of the Principal Investigator, has a concomitant medical illness which would preclude them from being treated with amantadine,
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,
Any subject with evidence for dementia, depression, or psychosis, as determined by clinical examination.
Any subject who has not signed informed consent, or unable or unwilling to participate in all of the study related activities.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher G Goetz, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease
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