Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia
NCT ID: NCT02589340
Last Updated: 2021-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
6 participants
INTERVENTIONAL
2016-01-31
2021-02-23
Brief Summary
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Detailed Description
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Methods: Eligible subjects who consent to participate in this study will be randomized to one of two sequences of treatment interventions during the baseline visit. Each treatment sequence includes placebo and buspirone interventions. After randomization, each participant will titrate up on study drug for two weeks ending in 30 mg/day. At the end of each two week study drug period, the participant will then have a study visit at the VA Portland Health Care System that includes safety monitoring, adverse event monitoring, drug compliance, and several measurements of LID.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Buspirone
Two week titration up to 10 mg tablet/3 times a day for 7 days
Buspirone
Placebo
Two week titration up to 3 tablets/3 times a day for 7 days
Placebo
Sugar Pill
Interventions
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Buspirone
Placebo
Sugar Pill
Eligibility Criteria
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Inclusion Criteria
* Currently taking a levodopa containing medication for Parkinson's disease
* Mild to Severe dyskinesia
* Currently taking between 200-500 mg of amantadine daily for treatment of levodopa-induced dyskinesia with insufficient suppression levodopa-induced dyskinesia.
* Stable medication regimen for at least 4 weeks prior to study.
Exclusion Criteria
* Not able to follow verbal commands
* Not able to stand unsupported for at least 60 seconds
* Not able to answer a patient questionnaire about their symptoms of Parkinson's disease and dyskinesia.
* Have proprioceptive deficits.
* Have a history of hepatic impairment
* Currently have severe renal impairment
* Currently have any other medical or psychiatric diagnosis that would preclude their ability to safely participate in the study.
* Significant cognitive impairment
* Pregnancy
* Breast-Feeding
* Unable to swallow study drug (capsule)
18 Years
99 Years
ALL
No
Sponsors
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Portland VA Medical Center
FED
Oregon Health and Science University
OTHER
Responsible Party
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Kathryn Anne Chung
Associate Professor - Neurology
Locations
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VA Portland Health Care System
Portland, Oregon, United States
Countries
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References
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McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. No abstract available.
Other Identifiers
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11875
Identifier Type: -
Identifier Source: org_study_id
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