Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the efficacy of buspirone in combination with amantadine in reducing levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).

Detailed Description
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Plan: We will perform a randomized, placebo-controlled, double-blind, two-period cross-over study to evaluate the safety, tolerability, and efficacy of a novel treatment combination for LID in PD. 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.

Official Title
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Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia

Conditions
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Parkinson's Disease, Dyskinesias, Movement Disorders

Intervention / Treatment
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* Drug: Buspirone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parkinson's disease diagnosis 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: Currently receiving any other treatment for levodopa-induced dyskinesia, including but not exclusive to deep brain stimulation. 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buspirone<br>Two week titration up to 10 mg tablet/3 times a day for 7 days | Drug: Buspirone<br> <br> |
| Placebo Comparator: Placebo<br>Two week titration up to 3 tablets/3 times a day for 7 days | Drug: Placebo<br>* Sugar Pill<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve - Dyskinesia - Forceplate | forceplate measurements of levodopa induced dyskinesia taken every 1/2 hour for 6 hours. | 6 hour levodopa dose cycle | 
| Dyskinesia - UDysRS | UDysRS total score comparison | up to 6 weeks | 
| Adverse Events | Adverse Events Monitoring/Frequency | up to 6 weeks |