Status:
Not Yet Recruiting
Clinicaltrials.gov identifier:
Sponsor:
Contera Pharma
Enrollment:
81
Study Design:
Randomized, double-blind, double dummy, placebo-controlled, parallel group study. This Phase 2 study is comparing two dose levels of JM-010 with placebo - 4mg buspirone/0.8mg zolmitriptan and 8mg buspirone/0.8mg zolmitriptan. The time period will be 12 weeks with a further 2 weeks follow up for safety purposes. There will also be a pharmacokinetic (PK) sub-study. There are three sub-groups in the study with participants randomised in a 1:1:1 ratio. Group 1 will receive the first active dose plus a placebo; group 2 the second active dose plus a placebo; and group 3 two placebos. The study is seeking PwP between the ages of 18 and 80 on a stable regimen of levodopa. Inclusion criteria also include stable peak effect dyskinesia and at least one hour of ON state dyskinesia during waking hours, with no more than six administrations of levodopa per day. Exclusively diphasic, OFF state, myoclonic, dystonic, or akathetic dyskinesia without peak-dose dyskinesia are all excluded.
Rationale:
Primary - the efficacy of JM-010 compared to placebo using the UDysRS over 12 weeks. Secondary outcomes are also focused on efficacy: 1. UDysRS total score changes from baseline to weeks 2, 4 and 8; 2. MDS-UPDRS Parts I to IV from baseline to week 2, 4, 8, 12; 3. Clinician’s Global Impression of Change (CGIC) score at week 12; 4. Change in ON time with troublesome dyskinesia, ON time with non-troublesome dyskinesia, ON time without dyskinesia, and OFF time as measured by Hauser patient diaries at weeks 2, 4, 8 and 12.
Results:
The first trial specifically explores the anti-dyskinetic benefit of buspirone and is monitoring its effect on parkinsonism as well. The 2nd study explores if buspirone potentiates the anti-dyskinetic effect of amantadine and the last study tests the synergistic effect of buspirone with zolmitriptan. All studies are studying a lower dose of buspirone, unlikely to worsen parkinsonism. Whether buspirone will deliver on the results as an anti-dyskinetic is yet to be seen.
