CERE - Dosing underway in Cerevel Therapeutics' tavapadon trials for Parkinson's disease
The first participants have been dosed in Cerevel Therapeutics' (CERE) all three of the clinical trials in their Phase 3 program evaluating tavapadon in patients with Parkinson’s disease. The Phase 3 program includes three 27-week, placebo-controlled, parallel-group trials designed to evaluate the efficacy, safety and tolerability of fixed doses (TEMPO-1) and flexible doses (TEMPO-2) of tavapadon as a monotherapy in patients with early-stage Parkinson’s disease or as an adjunctive therapy to levodopa in patients with late-stage Parkinson’s disease who are experiencing motor fluctuations (TEMPO-3). Approximately 1,200 patients ages 40 to 80 years will be enrolled across all three trials. The primary endpoint of the TEMPO-1 and TEMPO-2 trials is the change from baseline in the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale. The change from baseline in total daily “on” time without troublesome dyskinesia is the primary endpoint of TEMPO-3 trial.A fourth 58-week, safety extension trial will also be conducted
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Dosing underway in Cerevel Therapeutics' tavapadon trials for Parkinson’s disease