Cerevel Therapeutics reported positive topline results from its Phase III TEMPO-3 clinical trial evaluating once-daily administration of tavapadone to treat Parkinson's disease.
Tavapadon is a D1/D5 receptor partial agonist.
A 27-week, parallel-group, flexible-dose, double-blind, randomized, placebo-controlled study investigated the efficacy, safety, and Tolerability was assessed. Year.
Patients were given a home diary (Hauser diary) to assess their motor status, with a baseline of total “on” time without bothersome dyskinesias based on the 2-day average of the self-administered Hauser diary. The primary endpoint of the trial was change from .
Change from baseline in total daily “off” time, change from baseline in total “on” and “off” time at previous time points, and Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) ) Change from baseline in Part I, II and III scores were key secondary endpoints.
Findings showed that patients treated with LD plus Tavapadon had an increase in total “on” time of 1.1 hours without bothersome dyskinesia and major The evaluation items were met.
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Additionally, a statistically significant reduction in total daily “off” time, an important secondary endpoint, was observed in the tavapadone treatment group.
Tavapadon was well tolerated in the trial and consistent with the safety profile of previous clinical studies.
Additionally, most adverse events reported in this trial were mild to moderate in severity.
Raymond Sanchez, chief medical officer of Cerevel Therapeutics, said: “Tavapadone's novel mechanism of action, which selectively activates D1/D5 dopamine receptors, demonstrates the potential to provide the right balance of motor control, safety, and tolerability for people living with Parkinson's disease.” Did.
“We are very encouraged by these results and are planning to launch two monotherapy trials, TEMPO-1 and TEMPO-2, later this year to evaluate the potential benefits of tavapadon for people living with Parkinson's disease. We look forward to sharing additional data from you.”