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

Phase 1

Terminated

• Conditions: Movement Disorders; Parkinson's Disease; Dyskinesias
• Interventions: Drug: Placebo; Drug: Buspirone

• Registration Number: NCT02589340
• Lead Sponsor: Oregon Health and Science University

Brief 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.

Study Timeline

• Study First Submitted: 2015-10-23
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-28
• Study Start: 2016-01
• Primary Completion: 2021-02-23
• Study Completion: 2021-02-23
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-03
• Last Update Posted: 2021-03-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Two week titration up to 3 tablets/3 times a day for 7 days
Buspirone	Buspirone	Two week titration up to 10 mg tablet/3 times a day for 7 days

Primary Outcome Measures

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

Trial Locations

Locations (1)

VA Portland Health Care System; 🇺🇸 Portland, Oregon, United States