Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease



Status:Terminated
Conditions:Other Indications, Parkinsons Disease
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:30 - 90
Updated:11/11/2017
Start Date:March 2013
End Date:July 2016

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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.


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.
We found this trial at
5
sites
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Christopher G Goetz, MD
Phone: 312-563-2900
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Mark Stacy, MD
Phone: 919-668-1538
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Robert Hauser, MD
Phone: 813-396-0757
University of South Florida The University of South Florida is a high-impact, global research university...
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Tampa, FL
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Birmingham, Alabama 35294
Principal Investigator: Anthony P Nicholas, MD
Phone: 205-996-2647
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Birmingham, AL
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Portland, Oregon 97227
Principal Investigator: Kathy Chung, MD
Phone: 503-273-5336
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Portland, OR
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