Tavapadon Improves Motor Function in Patients With Early Parkinson Disease

Topline results were announced from a phase 3 trial evaluating tavapadon, a selective dopamine D1/D5 receptor partial agonist, as monotherapy for the treatment of Parkinson disease (PD).

In the TEMPO-1 trial (ClinicalTrials.gov Identifier: NCT04201093), participants aged 40 to 80 years with early PD (N=529) were randomly assigned to receive tavapadon 5mg or 15mg once daily or placebo. The primary endpoint of the study was the change from baseline in the Movement Disorder Society-sponsored revision of the Unified Parkinson Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26. 

Findings showed treatment with tavapadon led to a statistically significant improvement in motor function compared with placebo (change from baseline in MDS-UPDRS Parts II and III combined score: placebo: +1.8; tavapadon 5mg: -9.7; tavapadon 15mg: -10.2; P <.0001 each dose vs placebo). Additionally, a statistically significant and clinically meaningful improvement in motor experiences of daily living (based on MDS-UPDRS Part II score) was reported in both dose groups compared with placebo (secondary endpoint).

“The TEMPO-1 data, coupled with the previously reported TEMPO-3 adjunctive trial findings, further support the potential of tavapadon for people living with Parkinson’s disease,” said Primal Kaur, MD, MBA, senior vice president, immunology, neuroscience, eye care and specialty development, AbbVie.

Full study data from TEMPO-1 is expected to be presented at a future medical meeting. Topline results from the TEMPO-2 monotherapy trial (ClinicalTrials.gov Identifier: NCT04223193) are anticipated at the end of this year. The TEMPO clinical development program also includes an open-label extension trial (TEMPO-4; ClinicalTrials.gov Identifier: NCT04760769) that will assess the long-term safety and tolerability of tavapadon.

This article originally appeared on MPR