Fixed-Dose Tavapadon for Early Parkinson Disease: A Randomized Clinical Trial - PubMed
7 hours ago
- #Clinical Trial
- #Parkinson's Disease
- #Dopaminergic Therapy
- Tavapadon is an oral, once-daily, selective D1/D5 agonist for early Parkinson's disease (PD).
- TEMPO-1 was a phase 3, double-blind, placebo-controlled trial across 12 countries with 529 participants.
- Participants received 5 mg or 15 mg tavapadon or placebo for 27 weeks.
- Primary endpoint: significant improvement in MDS-UPDRS parts II and III combined score for both doses vs placebo.
- Secondary endpoints included MDS-UPDRS part II scores and Patient Global Impression of Change.
- Tavapadon showed a favorable safety profile with common AEs being nausea, headache, and dizziness.
- The study concluded tavapadon improves motor function in early PD and is well-tolerated.