Tavapadon for Early Parkinson Disease Shows Improvements in Motor and Daily Function in Phase 3 Study
KEY TAKEAWAYS
- Flexible-dose tavapadon met the primary endpoint in TEMPO-2, significantly improving combined MDS-UPDRS Parts II and III scores vs placebo at week 26.
- Secondary outcomes suggested benefit in measures of daily living and patient-reported global improvement.
- Adverse events and discontinuations were more common with tavapadon, particularly during titration.
Treatment with tavapadon (AbbVie, North Chicago, IL), an investigational once-daily selective D1/D5 dopamine receptor agonist, was shown to significantly improve motor and daily function scores in adults with early Parkinson disease (PD), according to results of the phase 3 TEMPO-2 study (NCT04223193) published in The Lancet Neurology.
TEMPO-2 was a randomized, double-blind, placebo-controlled trial conducted at 75 sites across 13 countries. The study included adults aged 40 to 80 years with early-stage PD, defined as disease duration of less than 3 years, who were treatment-naive or had received less than 3 months of prior dopaminergic therapy. Participants were randomly assigned to tavapadon 5 mg to 15 mg once daily (n=151) or placebo (n=153) for 27 weeks.
Clinical Trial Results
- Tavapadon treatment was associated with improvement in combined Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts II and III score from baseline to week 26 compared with placebo.
- Least-squares mean change in the combined MDS-UPDRS Parts II and III score showed an improvement of 10.3 points with tavapadon versus 1.2 points with placebo, for a treatment difference of 9.1 points (95% CI, -11.7 to -6.5; P<.0001).
- Tavapadon treatment was also shown to improve MDS-UPDRS Part II score vs placebo (treatment difference, -1.5; P=.0007).
- A higher proportion of tavapadon-treated participants reported being “much improved” or “very much improved” on Patient Global Impression of Change compared with placebo (46% vs 19%; P<.0001).
Adverse events occurred in 76% of tavapadon-treated participants and 55% of placebo-treated participants. Discontinuation due to adverse events was also more frequent with tavapadon (24% vs 4%). The most common adverse events with tavapadon were nausea (30%), headache (17%), and dizziness (16%). Rates of somnolence were low (3% with tavapadon vs 4% with placebo), and impulse control disorders were reported in 1% and 0%, respectively. No dyskinesia was reported in either group.
Source
Fernandez HH, Bhatia P, Cloud L, et al. Safety, tolerability, and efficacy of flexible-dose tavapadon for Parkinson’s disease (TEMPO-2): a phase 3, randomised, placebo-controlled, double-blind trial. Lancet Neurol. 2026;25(8):721-730. doi:10.1016/S1474-4422(26)00215-2.