Status:
Recruiting
Clinicaltrials.gov identifier:
Sponsor:
Oregon Health and Science University
Enrollment:
15
Study Design:
This is a phase 1, single-center, double-blinded, randomized, placebo-controlled, two-period cross-over study designed to assess the safety, tolerability, and efficacy of combination therapy of buspirone and amantadine on dyskinesia. They are enrolling PD participants between 18 to 99 years of age on a stable medication regimen. Participants should have mild to severe dyskinesia and should be on amantadine (200-500mg/day) with insufficient control. Standard exclusionary criteria are applied. This study will not include participants with DBS. Included participants will be randomized to one of the two study arms. Arm 1: Buspirone titrated up over the course of 2 weeks to reach 30mg/day for a week. Arm 2: Placebo titrated up to match arm 1. Participants will be crossed over the treatment sequence. Monitoring is done every 2 weeks for safety, tolerance, compliance and dyskinesia assessment.
Rationale:
The primary outcome measure will assess the: 1. Area under the curve – measurements for dyskinesia for a 6-hr levodopa dose cycle; 2. Change in UdysRS up to 6 weeks; 3. Safety and tolerability assessment by monitoring adverse events for up to 6 weeks. No secondary outcomes have been specified.
Comments:
None.
