Fixed-Dose Tavapadon for Early Parkinson Disease

作者：R. Pahwa, E. Moro, Alberto J. Espay, AH Evans, Marie Saint-Hilaire, Diego R. Torres-Russotto, Raymond Sanchez, Matthew J. Leoni, Sridhar Reddy Duvvuri, Cari Combs, Ih Chang, Stacey Tringali, Joey C Boiser, Cindy Zadikoff, Angelo Antonini · 发表于：JAMA Neurology · 年份：2026 · DOI：10.1001/jamaneurol.2026.0590 · 被引用次数：11 · 研究领域：Parkinson's Disease Mechanisms and Treatments、Parkinson's Disease and Spinal Disorders、Electroconvulsive Therapy Studies

Importance: Tavapadon is an oral, once-daily, selective D1/D5 agonist that may improve Parkinson disease (PD) motor symptoms while minimizing adverse events (AEs) associated with D2/D3 receptor activation. Objective: To evaluate the efficacy, safety, and tolerability of tavapadon in adults with early PD. Design, Setting, and Participants: TEMPO-1 was a phase 3, double-blind, placebo-controlled randomized clinical trial conducted at 102 sites across 12 countries between December 2019 and June 2024. Adults with early PD (<3 years' disease duration) who were treatment naive or had less than 3 months of prior dopaminergic treatment were eligible for enrollment. Data analysis was completed from July 2024 to May 2025. Intervention: Participants were randomized 1:1:1 to receive 1 of 2 fixed doses of tavapadon (5 or 15 mg once daily) or placebo for 27 weeks, followed by a 4-week safety follow-up period. Main Outcomes and Measures: The primary end point was least-squares mean (LSM) change from baseline to week 26 in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) parts II and III combined score. Key secondary end points were LSM change from baseline to week 26 in MDS-UPDRS part II scores and the proportion of participants with a score of "much improved" or "very much improved" on the Patient Global Impression of Change. Results: Overall, 751 adults with early PD who were treatment naive or had less than 3 months of prior dopaminergic treatment were scree...