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

Primary Purpose

Parkinson's Disease, Dyskinesias, Movement Disorders

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Buspirone
Placebo
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • VA Portland Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Buspirone

Placebo

Arm Description

Two week titration up to 10 mg tablet/3 times a day for 7 days

Two week titration up to 3 tablets/3 times a day for 7 days

Outcomes

Primary Outcome Measures

Area Under the Curve - Dyskinesia - Forceplate
forceplate measurements of levodopa induced dyskinesia taken every 1/2 hour for 6 hours.
Dyskinesia - UDysRS
UDysRS total score comparison
Adverse Events
Adverse Events Monitoring/Frequency

Secondary Outcome Measures

Full Information

First Posted
October 23, 2015
Last Updated
March 3, 2021
Sponsor
Oregon Health and Science University
Collaborators
Portland VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02589340
Brief Title
Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia
Acronym
BUS-PD
Official Title
Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
January 2016 (undefined)
Primary Completion Date
February 23, 2021 (Actual)
Study Completion Date
February 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Portland VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Dyskinesias, Movement Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Buspirone
Arm Type
Experimental
Arm Description
Two week titration up to 10 mg tablet/3 times a day for 7 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two week titration up to 3 tablets/3 times a day for 7 days
Intervention Type
Drug
Intervention Name(s)
Buspirone
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sugar Pill
Primary Outcome Measure Information:
Title
Area Under the Curve - Dyskinesia - Forceplate
Description
forceplate measurements of levodopa induced dyskinesia taken every 1/2 hour for 6 hours.
Time Frame
6 hour levodopa dose cycle
Title
Dyskinesia - UDysRS
Description
UDysRS total score comparison
Time Frame
up to 6 weeks
Title
Adverse Events
Description
Adverse Events Monitoring/Frequency
Time Frame
up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
VA Portland Health Care System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31356217
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.
Results Reference
derived

Learn more about this trial

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

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