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

Parkinson's Disease Clinical Trial

— BUS-PD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02589340
• Other study ID #: 11875
• Status: Terminated
• Phase: Phase 1
• Start date: January 2016
• Est. completion date: February 23, 2021

Study information

• Verified date: March 2021
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: February 23, 2021
• Est. primary completion date: February 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dyskinesias
• Movement Disorders
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Buspirone

• Placebo
Sugar Pill

Locations

Country	Name	City	State
United States	VA Portland Health Care System	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Portland VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Dyskinesia - UDysRS	UDysRS total score comparison	up to 6 weeks
Primary	Adverse Events	Adverse Events Monitoring/Frequency	up to 6 weeks