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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

Page last updated: August 23, 2015

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