In the open-label trial, 34 participants received twice-daily doses of the investigational compound for six weeks, with 25 continuing into an 18-week extension. Clinical observations indicated a notable increase in "Good ON-time"—periods of symptom control without troublesome dyskinesia—alongside a reduction in daily "OFF-time" when symptoms return. Furthermore, the study noted a significant decrease in the severity of dyskinesia and a reduction in the mean daily levodopa dose required by patients.
The safety profile remained consistent with the drug’s dopaminergic mechanism of action, with most adverse events, such as nausea and dizziness, reported as mild. While these results offer a potential path forward for patients seeking to avoid invasive treatment options, the company emphasized that the trial was exploratory and lacked a placebo control. Building on these results, Lundbeck has officially launched the DARE2 Phase II trial, a randomized, double-blind study involving approximately 150 patients across multiple countries to further validate the drug’s efficacy and safety.



Comments (0)
No comments yet. Be the first!