Significant reduction also seen in change from baseline in daily OFF times versus placebo<\/p>\n<\/h3>\n
By Elana Gotkine HealthDay Reporter<\/b>
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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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
“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.<\/p>\n
The study was funded by AbbVie, the manufacturer of tavapadon.<\/p>\n