Adamas completes recruitment in Phase III EASE LID trial evaluating ADS-5102

EASE LID is a confirmatory trial designed to evaluate the efficacy and safety of ADS-5102 for the treatment of levodopa-induced dyskinesia (LID), a motor complication associated with the treatment of Parkinson’s disease.

"This important achievement brings us one step closer to our goal of filing a New Drug Application in 2016 for ADS-5102 for the treatment of LID," said Gregory T. Went, Ph.D., Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc.

"With recruitment of this Phase 3 study now complete, we are on track to announce top-line results in the first quarter of 2016."

EASE LID, which is enrolling approximately 120 individuals, is a 26-week multi-center, randomized, double-blind, placebo-controlled study assessing the efficacy of a 340 mg dose of ADS-5102 administered once daily at bedtime.

The primary endpoint of EASE LID is a reduction in dyskinesia assessed by change from baseline to week 12 in UDysRS (a tool that assesses the disability and impairment of LID in Parkinson’s disease) with a key secondary endpoint being change in ON time without troublesome dyskinesia as measured by patient diaries. Safety and tolerability are also being assessed.

In addition to EASE LID, Adamas has two ongoing Phase 3 clinical trials of ADS-5102 for the treatment of LID in individuals with Parkinson’s disease. These clinical trials were initiated following the completion of a Phase 2/3 study.