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History of Changes for Study: NCT02589340
Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia (BUS-PD)
Latest version (submitted March 3, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 26, 2015 None (earliest Version on record)
2 September 29, 2016 Recruitment Status, Study Status, Sponsor/Collaborators, Contacts/Locations and Oversight
3 January 8, 2018 Study Status
4 March 29, 2019 Study Status
5 March 13, 2020 Recruitment Status, Study Status and Contacts/Locations
6 March 3, 2021 Recruitment Status, Study Status and Study Design
Comparison Format:
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Changes (Side-by-Side) for Study: NCT02589340
October 26, 2015 (v1) -- March 3, 2021 (v6)

Changes in: Study Status, Sponsor/Collaborators, Oversight, Study Design and Contacts/Locations
Open or close this module Study Identification
Unique Protocol ID: 11875 11875
Brief Title: Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia (BUS-PD)Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia (BUS-PD)
Official Title: Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2015 March 2021
Overall Status: Not yet recruitingTerminated [Low enrollment]
Study Start: January 2016 January 2016
Primary Completion: December 2017 [Anticipated] February 23, 2021 [Actual]
Study Completion: December 2017 [Anticipated] February 23, 2021 [Actual]
First Submitted: October 23, 2015 October 23, 2015
First Submitted that
Met QC Criteria:		 October 26, 2015 October 26, 2015
First Posted: October 28, 2015 [Estimate] October 28, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:		 October 26, 2015 March 3, 2021
Last Update Posted: October 28, 2015 [Estimate] March 5, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Oregon Health and Science University Oregon Health and Science University
Responsible Party: Principal Investigator
Investigator: Victoria Holiday
Official Title: Fellow - Neurology
Affiliation: Oregon Health and Science University
 Principal Investigator
Investigator: Kathryn Anne Chung
Official Title: Associate Professor - Neurology
Affiliation: Oregon Health and Science University
Collaborators: Portland VA Medical Center Portland VA Medical Center
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No No
Open or close this module 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). 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.

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.
Open or close this module Conditions
Conditions: Parkinson's Disease
Dyskinesias
Movement Disorders 		Parkinson's Disease
Dyskinesias
Movement Disorders
Keywords:
Open or close this module Study Design
Study Type: InterventionalInterventional
Primary Purpose: TreatmentTreatment
Study Phase: Phase 1Phase 1
Interventional Study Model: Crossover Assignment Crossover Assignment
Number of Arms: 22
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: RandomizedRandomized
Enrollment: 15 [Anticipated] 6 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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. 		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 		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 		Adverse Events
[ Time Frame: up to 6 weeks ]

Adverse Events Monitoring/Frequency
Open or close this module Eligibility
Minimum Age: 18 Years 18 Years
Maximum Age: 99 Years 99 Years
Sex: All All
Gender Based:
Accepts Healthy Volunteers: NoNo
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)

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)
Open or close this module Contacts/Locations
Central Contact Person: Brenna M Lobb, MS MPH
Telephone: 503.220.8262 Ext. 51871
Email: lobbb@ohsu.edu
Central Contact Backup: Susan O'Connor, RN
Telephone: 503.220.8262 Ext. 55336
Locations: United States, Oregon
VA Portland Health Care System
Portland, Oregon, United States, 97239
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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