Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia (BUS-PD)

Oregon Health & Science University (OHSU)

Status and phase

Terminated

Phase 1

Conditions

Movement Disorders

Parkinson's Disease

Dyskinesias

Treatments

Drug: Buspirone

Drug: Placebo

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT02589340

11875

Details and patient eligibility

About

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).

Full 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.

Enrollment

6 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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)