Status:
Active, No Longer Recruiting
Clinicaltrials.gov identifier:
Sponsor:
Cerevel Therapeutics, LLC
Enrollment:
296
Study Design:
This is a phase 3, double-blind, randomized, placebo-controlled, parallel-group, flexible-dose, 27-week trial designed to evaluate the efficacy, safety, and tolerability of tavapadon in participants with early PD. The inclusion and exclusion criteria for TEMPO-2 are the same as TEMPO-1. This study has two arms: 1. Experimental arm where participants will be randomized to receive tavapadon anywhere from 5 to 15mg daily for 27 weeks; and 2. Placebo comparator arm where participants will receive a placebo for 27 weeks. The study is being conducted at seven sites across the USA, different to the TEMPO-1 study sites.
Rationale:
The primary and secondary outcome measures for TEMPO-2 are similar to TEMPO-1 with minor changes in duration. The primary outcome remains the same as TEMPO-1 and will assess the change in MDS-UPDRS part II and III combined score up to 27 weeks from baseline. The secondary measures are the same as TEMPO-1 except for the change in MDS-UPDRS I, II, and III individual scores will be assessed up to 29 weeks.
