A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson’s Disease (TEMPO-1 TRIAL)

Active, No Longer Recruiting
Cerevel Therapeutics, LLC
Study Design: 
This is a phase 3, randomized, parallel assigned, double-blinded, placebo-controlled, fixed-dose study evaluating the efficacy, safety and tolerability, and pharmacokinetics of two fixed doses of tavapadon in participants with early PD. Clinically diagnosed PD participants between age 40-80 years with H&Y stage less than 2 and within 3 years of disease duration from the time of diagnosis are eligible to participate. The MDS-UPDRS part II and III scores should be ≥2 and 10, respectively, at the time of screening. Participants should be dopaminergic drug naïve and be willing to refrain from non-permitted PD medications. Participants who have been taking dopaminergic agents but for less than three months and at least two months before signing consent will be eligible for inclusion. The use of MAO-Inhibitors is allowed. Apart from standard exclusionary criteria, participants with impulse control disorders, certain neuropsychiatric symptoms, and MoCA <26 will be excluded. The participants will be randomized to one of the three arms, which are: 1. Experimental arms: there will be two experimental arms where participants will be randomized to receive tavapadon titrated to either 5mg or 15mg orally daily for 27 weeks; and 2. Comparator arm where participants will receive a matching placebo orally once a day for 27 weeks. The study is being conducted at 11 sites across the USA.
The primary outcome assesses the change in MDS-UPDRS parts II and III combined score up to 27 weeks from baseline. The secondary measures include the following: 1. Percentage of responders with ‘Much improved’ or ‘Very much im-proved’ rating on the Participant global impression of change (PGIC) up to 27 weeks; 2. The PGIC score up to 27 weeks; 3. Change in MDS-UPDRS I, II, and III combined and individual scores up to 27 weeks from base-line; 4. Change in Clinical global impression (CGI) - severity of illness score and CGI- Improvement score up to 27 weeks from baseline; 5. Change in Epworth sleepiness scale, Impulsive-compulsive disorders in Parkinson’s dis-ease rating scale up to 27 weeks; 6. Change in Columbia-suicide severity rating scale up to 27 weeks; and 7. Number of participants with treatment-emergent adverse events will be monitored up to 31 weeks.