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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
Last Update Posted : November 7, 2016
Information provided by (Responsible Party):

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 PD patients who continue to have dyskinesia on amantadine.

Condition or disease Intervention/treatment Phase
Idiopathic Parkinson's Disease Drug Induced Dyskinesia Drug: Topiramate Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease
Study Start Date : March 2013
Primary Completion Date : July 2016
Study Completion Date : July 2016

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Topiramate
Topiramate as adjunct to amantadine.
Drug: Topiramate
Topiramate as adjunct to amantadine
Other Name: Topomax
Placebo Comparator: Placebo (sugar pill)
Drug: Placebo
Placebo control
Other Name: sugar pill

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Clinical Global Impression - Change score [ Time Frame: Assessed at Week 10 and 14 by blinded treating physician and subject ]

Other Outcome Measures:
  1. 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

  2. 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Parkinson's disease patient, defined by UK Brain Bank criteria
  2. Current age between 30-90
  3. Clinically pertinent dyskinesias defined by 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789047

United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35233
United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97201
Sponsors and Collaborators
Rush University Medical Center
Michael J. Fox Foundation for Parkinson's Research
Principal Investigator: Christopher G Goetz, MD Rush University Medical Center
More Information

Responsible Party: Christopher G. Goetz, MD, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01789047     History of Changes
Other Study ID Numbers: TOP-DYSK
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: November 2016

Keywords provided by Christopher G. Goetz, MD, Rush University Medical Center:
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Dyskinesia, Drug-Induced
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Neurotoxicity Syndromes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action