Clinical trial NCT02589340: Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia
Official title: Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Parkinson's Disease
Dyskinesias
Movement Disorders
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Portland VA Medical Center
First posted: 2015-10-28
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Area Under the Curve - Dyskinesia - Forceplate
timeFrame: 6 hour levodopa dose cycle
measure: Dyskinesia - UDysRS
timeFrame: up to 6 weeks
measure: Adverse Events
timeFrame: up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System
state: Oregon
Study officials:
References:
citation: McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. No abstract available.