In a phase 3 randomized clinical trial of adults with ParkinsonDisease experiencing motor fluctuations despite stable levodopa therapy, adjunctive tavapadon—a once-daily, selective D1/D5 dopamine agonist—significantly increased daily on-time without troublesome dyskinesia and reduced off-time compared with placebo over 27 weeks.
Most adverse events, including nausea, dyskinesia, and dizziness, were mild to moderate. Tavapadon showed a favorable safety profile and provided clinically meaningful motor improvements as adjunctive therapy.
Question Can adjunctive tavapadon—an oral, once-daily, selective dopamine (D) D1/D5 agonist—improve motor control for people with Parkinson disease (PD) experiencing motor fluctuations while minimizing risk of adverse events?
Findings In this phase 3, double-blind, placebo-controlled, 27-week randomized clinical trial of 507 participants with PD, tavapadon significantly increased daily on-time without troublesome dyskinesia (good-on-time) vs placebo. Most adverse events were mild to moderate in severity with nausea, dyskinesia, and dizziness most common with tavapadon.
Meaning Results show that tavapadon adjunctive to levodopa provided clinically meaningful motor improvements and an acceptable safety profile in adults with PD experiencing motor fluctuations while receiving oral levodopa.
