Study Stopped
Low enrollment
Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia
BUS-PD
1 other identifier
interventional
6
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2016
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2015
CompletedFirst Posted
Study publicly available on registry
October 28, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2021
CompletedMarch 5, 2021
March 1, 2021
5.2 years
October 23, 2015
March 3, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Area Under the Curve - Dyskinesia - Forceplate
forceplate measurements of levodopa induced dyskinesia taken every 1/2 hour for 6 hours.
6 hour levodopa dose cycle
Dyskinesia - UDysRS
UDysRS total score comparison
up to 6 weeks
Adverse Events
Adverse Events Monitoring/Frequency
up to 6 weeks
Study Arms (2)
Buspirone
EXPERIMENTALTwo week titration up to 10 mg tablet/3 times a day for 7 days
Placebo
PLACEBO COMPARATORTwo week titration up to 3 tablets/3 times a day for 7 days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oregon Health and Science Universitylead
- Portland VA Medical Centercollaborator
Study Sites (1)
VA Portland Health Care System
Portland, Oregon, 97239, United States
Related Publications (1)
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.
PMID: 31356217DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor - Neurology
Study Record Dates
First Submitted
October 23, 2015
First Posted
October 28, 2015
Study Start
January 1, 2016
Primary Completion
February 23, 2021
Study Completion
February 23, 2021
Last Updated
March 5, 2021
Record last verified: 2021-03