Status:
Recruiting
Clinicaltrials.gov identifier:
Sponsor:
Prilenia Therapeutics
Enrollment:
135
Study Design:
This is a multicentre, double-blind, randomized, three-arm, parallel-group Phase 2 study evaluating the efficacy and safety of two doses of pridopidine vs placebo for dyskinesia in PD participants. The study will include participants with a clinical diagnosis of PD between the ages of 30 and 85 years. Mild to moderate dyskinesia is a prerequisite. Participants are required to be on a stable medication regimen (PD and non-PD) for at least 28 days prior to the study start date and be able to maintain that through the study duration. Standard exclusionary criteria apply. Participants with surgical intervention such as DBS are excluded. The participants will be randomized to one of 3 parallel arms: Arm 1- dose 1 in the form of oral capsules for 12 weeks following a 2 week titration period; Arm 2- dose 2 in the form of oral capsules for 12 weeks following a 2-week titration period; Arm 3- placebo in the form of oral capsules for 14 weeks. The study is currently recruiting participants at two sites in the USA.
Rationale:
The primary outcome measure explores the change in dyskinesia from baseline to week 14. The score is calculated as a sum of parts 1, 3, and 4 of the UdysRS. No secondary outcomes have been posted.
Comments:
The pharmacology of the molecule and data from animal studies are promising. Given an established safety profile, it is one step ahead in the development for dyskinesia. Physiologically its effect is similar to GDNF growth factors in terms of neuronal dopamine protection and sprouting in the nigrostriatal axons. Though it failed to show efficacy for the HD population, its effect on dyskinesia is yet to be determined.
