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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
6
VA Portland Health Care System
Portland, Oregon, United States
Area Under the Curve - Dyskinesia - Forceplate
forceplate measurements of levodopa induced dyskinesia taken every 1/2 hour for 6 hours.
Time frame: 6 hour levodopa dose cycle
Dyskinesia - UDysRS
UDysRS total score comparison
Time frame: up to 6 weeks
Adverse Events
Adverse Events Monitoring/Frequency
Time frame: up to 6 weeks
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