NCT02589340

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Parkinson's Disease
• Dyskinesias
• Movement Disorders

Interventions

Type	Name	Description
DRUG	Buspirone
DRUG	Placebo	Sugar Pill

Timeline

• Start date: 2016-01-01
• Primary completion: 2021-02-23
• Completion: 2021-02-23
• First posted: 2015-10-28
• Last updated: 2021-03-05

Locations

1 site across 1 country: United States