Raymond Sanchez, MD: Phase 3 TEMPO Trials Guide Tavapadon

“We need to get a better understanding of what impact does this treatment have in terms of benefits on the motor score. How does that improve or impact the activities of daily living? Both trials will support our approach to getting this medication approved in early-stage Parkinson disease.”

Tavapadon, a potent, orally bioavailable, selective partial agonist of the dopamine D1 and D5 receptors, is being studied in the recently initiated trio fo phase 3 clinical trials called TEMPO-1 (NCT04201093), TEMPO-2 (NCT04223193), and TEMPO-3 (NCT04542499). Designed by Cerevel Therapeutics, the drug will be evaluated in patients with early- and late-stage Parkinson disease (PD) and will use change in the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part II and III combined as the primary end point of TEMPO-1 and TEMPO-2.

In phase 1 and 2 settings, the drug has demonstrated motor control benefit with the potential for an improved tolerability profile relative to D2/D3-preferring agonist. Now, the drug shifts gears to a phase 3 setting, with preliminary data readouts expected to be announced in the first half of 2023.

Raymond Sanchez, MD, chief medical officer, Cerevel Therapeutics, sat down with NeurologyLive to provide background on the TEMPO trials, and how they will be conducted going forward, and explain the goals of the assessments.