A registration-directed phase 3 program evaluating tavapadon (Cerevel Therapeutics, Boston, MA) for potential treatment of Parkinson disease (PD) has been initiated.
The 3 soon to be conducted double-blind randomized, placebo-controlled, parallel-group phase 3 clinical trials will enroll participants age 40 to 80 years. The participants will be people with early-stage PD (Tempo-1, Tempo-2) (NCT04201093) or people with late-stage PD who are experiencing motor fluctuations while on levodopa treatment (Tempo -3). Approximately 1,200 participants will be enrolled across all 3 trials. The primary endpoint of the Tempo-1 and Tempo-2 trials is the change from baseline in the Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) part 2 and part 3 combined score. The primary endpoint of the Tempo-3 trial is the change from baseline in total daily on time without troublesome dyskinesias.
In each of the 3 27-week trials, participants will be randomly assigned to treatment with tavapadon or placebo. In the Tempo-1 trial, study participants will be titrated up to a fixed dose of either 5 mg once dailyor 15 mg/day of tavapadon. In the Tempo-2 and Tempo-3 trials, participants will be titrated upward to a dose of between 5 mg and 15 mg QD in a flexible dosing paradigm.
The Tempo-1 and Tempo-2 trials have already initiated the screening of participants, and the Tempo-3 trial will begin screening later this year.
“PD affects approximately 10 million people worldwide, and there remains an important need for better and more effective therapies across the spectrum of this debilitating disease,” said Raymond Sanchez, MD, chief medical officer of Cerevel Therapeutics. “We believe tavapadon has the potential to improve outcomes for patients with both early-stage and late-stage PD. It is our expectation that the innovative design of each of these phase 3 trials will allow us to demonstrate tavapadon’s ability to improve patients’ motor symptoms and functioning. We anticipate data from these trials to be available beginning in the second half of 2022.”