Assessing Safety, Efficacy of Tavapadon in Improving Motor Function in Early PD

Background: Dopamine agonists (DAs) help reduce dyskinesias and on–off fluctuations in Parkinson disease (PD) patients. However, DAs currently available act on D2/D3 receptors with potential side effects of impulse control, edema, hallucinations, and somnolence. Might a selective D1/D5 agonist improve motor symptoms in early PD without these side effects? Objective: To evaluate the efficacy, safety, and tolerability of tavapadon, a D1/D5 agonist, in adults with early PD. Design: Prospective, double-blind, randomized placebo-controlled study (TEMPO-1). Participants/Methods: From 102 sites in 12 countries, 529 patients with early PD were randomized 1:1:1 to receive 5 mg or 15 mg daily dose of tavapadon or placebo for 26 weeks. Participants had Hoehn and Yahr scores of 1 to 2, Results: Significant improvement was seen in the combined scores for MDS-UPDRS parts II and III for tavapadon with a decrease of 9.7 points versus increase of 1.8 points for placebo with the 5-mg dose ( P P more...