Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease (TOP-DYSK)
This study is not yet open for participant recruitment.
Verified March 2013 by Rush University Medical Center
Sponsor:
Rush University Medical Center
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: March 20, 2013
Last verified: March 2013
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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:
|
|
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:
- Parkinson's disease patient, defined by UK Brain Bank criteria
- Current age between 30-90
- 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. *
- 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.
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 | Not yet recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Robert Hauser, MD | |
| United States, Illinois | |
| University of Alabama | Not yet recruiting |
| Birmingham, Illinois, United States, 35233 | |
| Contact: Anthony P Nicholas, MD | |
| Rush University Medical Center | Not yet 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 Lucia_M_Blasucci@rush.edu | |
| United States, North Carolina | |
| Duke University | Not yet recruiting |
| Durham, North Carolina, United States, 27705 | |
| Contact: Mark Stacy, MD | |
| United States, Oregon | |
| Oregon Health Sciences University | Not yet recruiting |
| Portland, Oregon, United States, 97201 | |
| Contact: 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: | March 20, 2013 |
| 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:
|
Anticonvulsants Dyskinesias Dyskinesia, Drug-Induced 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 |
ClinicalTrials.gov processed this record on May 22, 2013