Significant reduction also seen in change from baseline in daily OFF times versus placebo
By Elana Gotkine HealthDay Reporter
TUESDAY, April 8, 2025 (HealthDay News) — For patients with Parkinson disease with motor fluctuations, the oral once-daily, selective D1/D5 partial dopamine agonist tavapadon as an adjunct to levodopa increases total daily ON time versus placebo, according to a study presented at the annual meeting of the American Academy of Neurology, held from April 5 to 9 in San Diego.
Hubert Fernandez, M.D., from the Cleveland Clinic, and colleagues conducted a phase 3, placebo-controlled, double-blind trial to examine adjunctive therapy with tavapadon in adults experiencing motor fluctuations while receiving stable levodopa treatment. A total of 507 patients (aged 40 to 80 years) were enrolled and randomly assigned to adjunctive tavapadon (titrated to maximum tolerated flexible dose: 5 to 15 mg daily) or placebo in a 1:1 ratio.
The researchers found that tavapadon treatment significantly increased total daily ON time without troublesome dyskinesia (1.7 hours versus 0.6 hours with placebo). There was also a significant reduction in the change from baseline in daily OFF time compared with placebo. The safety profile of tavapadon was consistent with that seen in previous clinical trials; most adverse events were mild to moderate in severity.
“These findings in adults with Parkinson disease and motor fluctuations demonstrate the efficacy and acceptable safety profile of tavapadon as adjunctive therapy to levodopa,” the authors write.
The study was funded by AbbVie, the manufacturer of tavapadon.
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