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

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ClinicalTrials.gov Identifier: NCT02589340
Recruitment Status : Recruiting
First Posted : October 28, 2015
Last Update Posted : April 1, 2019
Sponsor:
Collaborator:
Portland VA Medical Center
Information provided by (Responsible Party):
Kathryn Anne Chung, Oregon Health and Science University

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 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
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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)

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


Contacts
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Contact: Brenna M Lobb, MS MPH 503.220.8262 ext 51871 lobbb@ohsu.edu
Contact: Susan O'Connor, RN 503.220.8262 ext 55336

Locations
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United States, Oregon
VA Portland Health Care System Recruiting
Portland, Oregon, United States, 97239
Contact: Brenna M Lobb, MS MPH    503-220-8262 ext 51871    lobbb@ohsu.edu   
Contact: Susan OConnor, RN    5032208262 ext 55336      
Principal Investigator: Kathryn Chung, MD         
Sponsors and Collaborators
Oregon Health and Science University
Portland VA Medical Center

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Responsible Party: Kathryn Anne Chung, Associate Professor - Neurology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02589340     History of Changes
Other Study ID Numbers: 11875
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Amantadine
Parkinson Disease
Dyskinesias
Movement Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Levodopa
Buspirone
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs