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Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease (TOP-DYSK)

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ClinicalTrials.gov Identifier: NCT01789047
Recruitment Status : Terminated (Sponsor withdrew support)
First Posted : February 11, 2013
Results First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Christopher G. Goetz, MD, Rush University Medical Center

Tracking Information
First Submitted Date  ICMJE February 7, 2013
First Posted Date  ICMJE February 11, 2013
Results First Submitted Date  ICMJE October 12, 2017
Results First Posted Date  ICMJE April 16, 2019
Last Update Posted Date April 16, 2019
Study Start Date  ICMJE March 2013
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
The Unified Dyskinesia Rating Scale (UDysRS) [ Time Frame: Change from baseline to week 14 (end of study) on the Unified Dyskinesia Rating Scale ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 7, 2013)
The Unified Dyskinesia Rating Scale (UDysRS) [ Time Frame: Baseline, Week 10 and week 14 performed by blinded rater ]
The Unified Dyskinesia Rating Scale (UDysRS) will be the primary outcome measure for this study. This choice is based on the outcome of the MJFF-funded 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.
Change History Complete list of historical versions of study NCT01789047 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2013)
Clinical Global Impression - Change score [ Time Frame: Assessed at Week 10 and 14 by blinded treating physician and subject ]
Current Other Pre-specified Outcome Measures
 (submitted: March 25, 2019)
  • Clinical Global Impression - Change Score [ Time Frame: Assessed at Week 10 and 14 by blinded treating physician and subject ]
    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".
  • Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: Assessed at baseline, week 6, week 10 and week 14 ]
    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
  • Hoehn & Yahr Staging [ Time Frame: Assessment completed at baseline, week 6, week 10 and week 14 ]
    Hoehn & Yahr staging of Parkinson's disease is completed by the blinded treating physician assessing the subject
Original Other Pre-specified Outcome Measures
 (submitted: February 7, 2013)
  • Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: Assessed at baseline, week 6, week 10 and week 14 ]
    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
  • Hoehn & Yahr Staging [ Time Frame: Assessment completed at baseline, week 6, week 10 and week 14 ]
    Hoehn & Yahr staging of Parkinson's disease is completed by the blinded treating physician assessing the subject
 
Descriptive Information
Brief Title  ICMJE Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease
Official Title  ICMJE Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Idiopathic Parkinson's Disease
  • Drug Induced Dyskinesia
Intervention  ICMJE
  • Drug: Topiramate
    Topiramate as adjunct to amantadine
    Other Name: Topamax
  • Drug: Placebo
    Placebo control
    Other Name: sugar pill
  • Drug: Amantadine
    Existing treatment for all participants
    Other Name: Symmetrel
Study Arms  ICMJE
  • Active Comparator: Topiramate
    Topiramate as adjunct to amantadine.
    Interventions:
    • Drug: Topiramate
    • Drug: Amantadine
  • Placebo Comparator: Placebo (sugar pill)
    Placebo
    Interventions:
    • Drug: Placebo
    • Drug: Amantadine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 25, 2019)
42
Original Estimated Enrollment  ICMJE
 (submitted: February 7, 2013)
55
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01789047
Other Study ID Numbers  ICMJE TOP-DYSK
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christopher G. Goetz, MD, Rush University Medical Center
Study Sponsor  ICMJE Rush University Medical Center
Collaborators  ICMJE Michael J. Fox Foundation for Parkinson's Research
Investigators  ICMJE
Principal Investigator: Christopher G Goetz, MD Rush University Medical Center
PRS Account Rush University Medical Center
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP