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

March 3, 2021 updated by: Kathryn Anne Chung, Oregon Health and Science University
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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • VA Portland Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

Portland VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ACTUAL)

February 23, 2021

Study Completion (ACTUAL)

February 23, 2021

Study Registration Dates

First Submitted

October 23, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (ESTIMATE)

October 28, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11875 (DAIDS-ES)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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