Tavapadon Improves Motor Control in Patients With Parkinson Disease

Treatment with tavapadon was associated with a clinically meaningful increase in total “on” time without troublesome dyskinesia in patients with Parkinson disease, according to topline results from the phase 3 TEMPO-3 trial.

Tavapadon is an oral, once-daily, selective dopamine D1/D5 receptor partial agonist designed to improve motor control while avoiding D2/D3 overstimulation. The pivotal double-blind, randomized, placebo-controlled, parallel-group, flexible-dose TEMPO-3 trial (ClinicalTrials.gov Identifier: NCT04542499) evaluated the efficacy and safety of tavapadon as adjunctive therapy in patients with Parkinson disease who were on a stable dose of levodopa and were experiencing motor fluctuations (N=507). 

Study participants were randomly assigned to receive tavapadon 5 to 15mg orally or placebo once daily as adjunctive therapy for 27 weeks. The primary endpoint was the change from baseline in the total “on” time without troublesome dyskinesia based on the 2-day average of the self-completed home diary for motor function status (Hauser diary).

Results showed treatment with tavapadon led to a statistically significant and clinically meaningful increase of 1.1 hours in total “on” time without troublesome dyskinesia compared with placebo (1.7 hours vs 0.6 hours, respectively; P <.0001). Moreover, tavapadon met the key secondary endpoint demonstrating a statistically significant reduction in “off” time. Full study results will be submitted for presentation at future medical meetings.

“Tavapadon’s novel mechanism of action, which selectively activates the D1/D5 dopamine receptors, has demonstrated the potential to provide people living with Parkinson disease the right balance of motor control, safety and tolerability,” said Raymond Sanchez, MD, chief medical officer, Cerevel Therapeutics. “We are highly encouraged with the results announced today, and look forward to sharing additional data later this year from the monotherapy trials, TEMPO-1 and TEMPO-2, as we seek to evaluate tavapadon’s potential benefit to people living with Parkinson disease.”

Topline results from the phase 3 TEMPO-1 (ClinicalTrials.gov Identifier: NCT04201093) and TEMPO-2 (ClinicalTrials.gov Identifier: NCT04223193) trials are expected in the second half of 2024.