Buspirone, in Combination With Amantadine, for the Treatm... | NCT02589340

Studies
Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia

NCT02589340

Sponsor

Oregon Health and Science University

Status

Terminated

Last Update Posted

Mar 5, 2021Actual

Enrollment

6Actual

Phase

Phase 1

Conditions

Parkinson's Disease
Dyskinesias
Movement Disorders

Interventions

Buspirone
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low enrollment

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Feb 23, 2021Actual

Completion Date

Feb 23, 2021Actual

First Submitted Date

Oct 23, 2015

First Submission Date that Met QC Criteria

Oct 26, 2015

First Posted Date

Oct 28, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2021

Last Update Posted Date

Mar 5, 2021Actual

Name	Class
Portland VA Medical Center	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Buspirone	Experimental	Two week titration up to 10 mg tablet/3 times a day for 7 days	Drug: Buspirone
Placebo	Placebo Comparator	Two week titration up to 3 tablets/3 times a day for 7 days	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Buspirone	Drug		Buspirone
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
VA Portland Health Care System		Portland	Oregon	97239	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31356217	Derived	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.

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D013141	Spiro Compounds
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals

ID	Term
D010300	Parkinson Disease
D020820	Dyskinesias
D009069	Movement Disorders