TEMPO-2 evaluated flexible-dose tavapadon (5–15 mg once daily, a selective oral D1/D5 dopamine agonist) vs. placebo over 27 weeks in 304 adults aged 40–80 with early-stage Parkinson's disease (<3 years' duration) who were treatment-naive or had <3 months of prior dopaminergic therapy.
Tavapadon significantly improved the MDS-UPDRS Parts II+III combined score vs. placebo at week 26 (LSM decrease −10.3 vs. −1.2 points; treatment difference −9.1 points [95% CI −11.7 to −6.5]; p<0.0001). Adverse events were more frequent with tavapadon (76% vs. 55%), with nausea (30% vs. 3%), headache (17% vs. 5%), and dizziness (16% vs. 3%) being the most common; discontinuation due to adverse events was higher in the tavapadon arm (24% vs. 4%).
- Short 27-week observation period limits conclusions about long-term tolerability and motor complications. - High discontinuation rate in the tavapadon arm (38% vs. 15% for placebo), mainly driven by adverse events, may affect interpretation of efficacy and tolerability. - Trial excluded patients with >3 months of prior dopaminergic treatment, limiting generalizability to a broader Parkinson's population.
Tavapadon offers a meaningful motor benefit in early Parkinson's disease with low rates of somnolence and impulse control disorders compared to D2/D3 agonists, but clinicians should counsel patients about nausea, headache, and dizziness—especially during titration—and monitor closely given the notably higher early dropout rate.
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