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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02589340
Recruitment Status : Terminated (Low enrollment)
First Posted : October 28, 2015
Last Update Posted : March 5, 2021
Sponsor:
Collaborator:
Portland VA Medical Center
Information provided by (Responsible Party):
Kathryn Anne Chung, Oregon Health and Science University

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : January 2016
Actual Primary Completion Date : February 23, 2021
Actual Study Completion Date : February 23, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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.

  2. Dyskinesia - UDysRS [ Time Frame: up to 6 weeks ]
    UDysRS total score comparison

  3. Adverse Events [ Time Frame: up to 6 weeks ]
    Adverse Events Monitoring/Frequency


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02589340


Locations
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United States, Oregon
VA Portland Health Care System
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Portland VA Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kathryn Anne Chung, Associate Professor - Neurology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02589340    
Other Study ID Numbers: 11875
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021
Additional relevant MeSH terms:
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Parkinson Disease
Dyskinesias
Movement Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Synucleinopathies
Neurodegenerative Diseases
Neurologic Manifestations
 Buspirone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action