Phase III trial of ADS 5102 (amantadine HCl) in Parkinsons disease meets primary endpoint- Adamas Pharmaceuticals

Adamas Pharmaceuticals has announced that its Phase III EASE LID clinical trial evaluating ADS 5102 (amantadine HCl) extended-release capsules for the treatment of levodopa-induced dyskinesia (LID) associated with Parkinson’s disease met its primary endpoint. Results from this randomized, placebo-controlled study showed a statistically significant reduction in LID at 12 weeks for patients who received ADS-5102 versus placebo as assessed by the Unified Dyskinesia Rating Scale (UDysRS). This represents a 23 percent reduction in LID for ADS-5102-treated patients compared to placebo.

The reduction in LID was maintained at 24 weeks, a key secondary analysis. The company plans to present comprehensive data at an upcoming scientific conference. In this study, there were four additional key secondary analyses based on patient diary data. All achieved statistical significance. Notably, at week 12, ADS-5102 significantly increased ON time without troublesome dyskinesia by 2.7 hours versus placebo and reduced OFF time by 0.9 hours. These effects were maintained at week 24.