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

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02589340
• Collaborator: Portland VA Medical Center (U.S. Fed)
• Enrollment: 6
• Location: 1
• Arms: 2
• Duration (Months): 61.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease; Dyskinesias; Movement Disorders	Drug: Buspirone; Drug: Placebo	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia
• Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Feb 23, 2021
• Actual Study Completion Date: Feb 23, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Buspirone Two week titration up to 10 mg tablet/3 times a day for 7 days	Drug: Buspirone
Placebo Comparator: Placebo Two week titration up to 3 tablets/3 times a day for 7 days	Drug: Placebo; Sugar Pill

Outcome Measures

Primary Outcome Measures

1. 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.

2. Dyskinesia - UDysRS [up to 6 weeks]

   UDysRS total score comparison

3. Adverse Events [up to 6 weeks]

   Adverse Events Monitoring/Frequency

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Portland Health Care System	Portland	Oregon	United States	97239

Sponsors and Collaborators

• Oregon Health and Science University
• Portland VA Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kathryn Anne Chung, Associate Professor - Neurology, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT02589340
• Other Study ID Numbers: 11875
• First Posted: Oct 28, 2015
• Last Update Posted: Mar 5, 2021
• Last Verified: Mar 1, 2021

• Additional relevant MeSH terms: Parkinson Disease; Dyskinesias; Movement Disorders; Buspirone

Study Results

No Results Posted as of Mar 5, 2021