Trial record 3 of 3 for:    Open Studies | "Dyskinesia, Drug-Induced"

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

This study is currently recruiting participants.
Verified April 2014 by Rush University Medical Center
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Christopher G. Goetz, MD, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01789047
First received: February 7, 2013
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Idiopathic Parkinson's Disease
Drug Induced Dyskinesia
Drug: Topiramate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • The Unified Dyskinesia Rating Scale (UDysRS) [ Time Frame: Baseline, Week 10 and week 14 performed by blinded rater ] [ Designated as safety issue: No ]
    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:
  • Clinical Global Impression - Change score [ Time Frame: Assessed at Week 10 and 14 by blinded treating physician and subject ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: Assessed at baseline, week 6, week 10 and week 14 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Hoehn & Yahr staging of Parkinson's disease is completed by the blinded treating physician assessing the subject


Estimated Enrollment: 55
Study Start Date: March 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Topiramate
Topiramate as adjunct to amantadine.
Drug: Topiramate
Topiramate as adjunct to amantadine
Other Names:
  • Topiramate
  • Topomax
Placebo Comparator: Placebo (sugar pill)
Placebo

  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01789047

Contacts
Contact: Christopher G Goetz, MD 312-942-8016 cgoetz@rush.edu
Contact: Glenn T Stebbins, PhD 312-563-3854 gstebbin@rush.edu

Locations
United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Contact: Claudia Rocha, CCRC    813-396-0757    crocha1@health.usf.edu   
Principal Investigator: Robert Hauser, MD         
United States, Illinois
University of Alabama Recruiting
Birmingham, Illinois, United States, 35233
Contact: Rachel Clark, RN    205-996-2647    rclarkrn@uab.edu   
Principal Investigator: Anthony P Nicholas, MD         
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Christopher G Goetz, MD    312-563-2900 ext Press 4    cgoetz@rush.edu   
Contact: Lucia M Blasucci, RN    312-563-2900 ext Press 4    movement_disorder@rush.edu   
Principal Investigator: Christopher G Goetz, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Lisa Gauger    919-668-1538    lisa.gauger@duke.edu   
Principal Investigator: Mark Stacy, MD         
United States, Oregon
Oregon Health Sciences University Recruiting
Portland, Oregon, United States, 97201
Contact: Susan M O'Connor, RN    503-273-5336    Susan.OConnor2@va.gov   
Principal Investigator: Kathy Chung, MD         
Sponsors and Collaborators
Rush University Medical Center
Michael J. Fox Foundation for Parkinson's Research
Investigators
Principal Investigator: Christopher G Goetz, MD Rush University Medical Center
  More Information

No publications provided

Responsible Party: Christopher G. Goetz, MD, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01789047     History of Changes
Other Study ID Numbers: TOP-DYSK
Study First Received: February 7, 2013
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Rush University Medical Center:
Parkinson's disease
dyskinesia
Indonesia
amantadine

Additional relevant MeSH terms:
Dyskinesia, Drug-Induced
Dyskinesias
Parkinson Disease
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Neurotoxicity Syndromes
Drug Toxicity
Poisoning
Substance-Related Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Neurodegenerative Diseases
Amantadine
Topiramate
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on April 23, 2014