Новый препарат тавападон показал высокую эффективность в лечении ранних стадий болезни Паркинсона

Tavapadon significantly and clinically meaningfully improves motor symptoms among patients with early Parkinson disease (PD), according to results of the Phase 3 TEMPO-2 trial published in The Lancet Neurology. In the Phase 3 randomized, double-blind, placebo-controlled TEMPO-2 trial (ClinicalTrials.gov Identifier: NCT04223193 ), researchers evaluated flexible-dose tavapadon for safety, tolerability, and efficacy in people with early-stage PD. The trial was conducted at 75 sites in 13 countries. Participants (N=304) aged 40 to 80 years who had been diagnosed with PD within the previous 3 years and were treatment-naive or had received less than 3 months of dopaminergic treatment were randomly assigned in a 1:1 ratio to receive tavapadon 5 to 15 mg (n=151) or placebo (n=153) for 27 weeks. The primary outcome was change from baseline to week 26 in the combined Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts II and III score. Of the participants, 56% were men, 88% were White, and their mean (SD) age was 62.9 (9.2) years. In total, 30% used monoamine oxidase-B inhibitors, and the mean (SD) baseline MDS-UPDRS Parts II and III combined score was 30.5 (11.2). These findings support the clinical potential of tavapadon as a treatment option that could improve symptom management of patients with early Parkinson’s disease and those with motor fluctuations. The change in MDS-UPDRS Parts II and III score with tavapadon differed significantly from placebo as early as week 4 ( P <.0001) and was maintained through week 27 (least-squares mean [LSM] treatment difference, -9.1; 95% CI, -11.7 to -6.5; P <.0001). For MDS-UPDRS Part II score, a significant difference from placebo was observed with tavapadon as early as week 8 ( P =.0020) and maintained through week 27 (LSM treatment difference, -1.5; 95% CI, -2.4 to -0.6; P =.0007). Tavapadon improved the combined MDS-UPDRS Parts II and III score significantly more than placebo as early as week 5, and the difference persisted through week 27. At week 26, the least-squares mean (LSM) change was -10.3 points with tavapadon and -1.2 points with placebo, producing an LSM treatment difference of -9.1 points (95% CI, -11.7 to -6.5; P <.0001). Tavapadon also produced a significantly greater improvement in MDS-UPDRS Part II than placebo beginning at week 8 and continuing through week 27. At week 26, the LSM treatment difference was -1.5 points (95% CI, -2.4 to -0.6; P =.0007). Participants receiving tavapadon were also more likely than those receiving placebo to report feeling much improved or very much improved on the Patient Global Impression of Change (odds ratio, 3.94; 95% CI, 2.21-7.04; P <.0001). Adverse events occurred in 76% of participants receiving tavapadon and 55% receiving placebo, with treatment-related events reported in 54% and 16%, respectively. Adverse events led to treatment discontinuation in 24% of participants receiving tavapadon compared with 4% receiving placebo. The most common adverse events with tavapadon included nausea (30%), headache (17%), dizziness (16%), fatigue (8%), vomiting (8%), dysgeusia (8%), falls (7%), and asthenia (5%). Safety outcomes of special interest included hallucinations (4%), hypotension (4%), somnolence (3%), orthostatic hypotension (3%), and impulse control disorders (1%). Tavapadon also reduced blood pressure more than placebo. Mean changes in standing systolic blood pressure were -10.8 mm Hg with tavapadon and -3.8 mm Hg with placebo, while mean changes in standing diastolic blood pressure were -7.0 and -0.8 mm Hg, respectively. Study limitations include the relatively short observation period, which limited conclusions about long-term tolerability. However, an ongoing extension study, TEMPO-4 (ClinicalTrials.gov Identifier: NCT04760769 ), is evaluating the longer-term safety and efficacy of tavapadon. The study authors concluded, “These findings support the clinical potential of tavapadon as a treatment option that could improve symptom management of patients with early Parkinson’s disease and those with motor fluctuations.” Disclosures: This research was supported by AbbVie. Please see the original reference for a full list of disclosures This article originally appeared on Neurology Advisor References: 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