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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01789047 |
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Date of registration:
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07/02/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease
TOP-DYSK |
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Scientific title:
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Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease |
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Date of first enrolment:
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March 2013 |
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Target sample size:
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42 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01789047 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Christopher G Goetz, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rush University Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Parkinson's disease patient, defined by United Kingdom (UK) Brain Bank criteria
2. Current age between 30-90
3. Clinically pertinent dyskinesias defined by Clinical Global Impression - Severity
(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.
Age minimum:
30 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Drug Induced Dyskinesia
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Idiopathic Parkinson's Disease
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Intervention(s)
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Drug: Placebo
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Drug: Topiramate
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Drug: Amantadine
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Primary Outcome(s)
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The Unified Dyskinesia Rating Scale (UDysRS)
[Time Frame: Change from baseline to week 14 (end of study) on the Unified Dyskinesia Rating Scale]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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