Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease
Information source: Rush University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Idiopathic Parkinson's Disease; Drug Induced Dyskinesia
Intervention: Topiramate (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Rush University Medical Center Official(s) and/or principal investigator(s): Christopher G Goetz, MD, Principal Investigator, Affiliation: Rush University Medical Center
Overall contact: Christopher G Goetz, MD, Phone: 312-942-8016, Email: cgoetz@rush.edu
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.
Clinical Details
Official title: Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The Unified Dyskinesia Rating Scale (UDysRS)
Secondary outcome: Clinical Global Impression - Change score
Eligibility
Minimum age: 30 Years.
Maximum age: 90 Years.
Gender(s): Both.
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.
Locations and Contacts
Christopher G Goetz, MD, Phone: 312-942-8016, Email: cgoetz@rush.edu
University of Alabama, Birmingham, Alabama 35233, United States; Recruiting Rachel Clark, RN, Phone: 205-996-2647, Email: rclarkrn@uab.edu Anthony P Nicholas, MD, Principal Investigator
University of South Florida, Tampa, Florida 33612, United States; Recruiting Claudia Rocha, CCRC, Phone: 813-396-0757, Email: crocha1@health.usf.edu Robert Hauser, MD, Principal Investigator
Rush University Medical Center, Chicago, Illinois 60612, United States; Recruiting Christopher G Goetz, MD, Phone: 312-563-2900, Ext: Press 4, Email: cgoetz@rush.edu Lucia M Blasucci, RN, Phone: 312-563-2900, Ext: Press 4, Email: movement_disorder@rush.edu Christopher G Goetz, MD, Principal Investigator
Duke University, Durham, North Carolina 27705, United States; Recruiting Lisa Gauger, Phone: 919-668-1538, Email: lisa.gauger@duke.edu Mark Stacy, MD, Principal Investigator
Oregon Health Sciences University, Portland, Oregon 97201, United States; Recruiting Susan M O'Connor, RN, Phone: 503-273-5336, Email: Susan.OConnor2@va.gov Kathy Chung, MD, Principal Investigator
Additional Information
Starting date: March 2013
Last updated: May 21, 2014
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