Adamas Completes Enrollment of Its Phase 3 EASE LID 3 Study Evaluating ADS-5102 for Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson’s Disease
EMERYVILLE, Calif., Dec. 14, 2015 (GLOBE NEWSWIRE) — Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced the completion of enrollment in its Phase 3 EASE LID 3 study. EASE LID 3 is a clinical 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.
“We are pleased to have completed enrollment of EASE LID 3, our third randomized clinical study in this indication, and we expect to maintain momentum in advancing our ADS-5102 program for the treatment of LID,” said Gregory T. Went, Ph.D., Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc. “We look forward to announcing top-line data from the EASE LID and EASE LID 3 trials in the near future and being one step closer to a potential new treatment option for Parkinson’s patients experiencing the often debilitating effects of levodopa-induced dyskinesia.”EASE LID 3, which enrolled 77 patients, is a 13-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 3 is a reduction in dyskinesia assessed by changes in Unified Dyskinesia Rating Scale (UDysRS) from baseline to week 12.Completed Phase 2/3 TrialEASED, a randomized, placebo-controlled, multi-center study, evaluated patients with Parkinson’s disease experiencing troublesome LID. Patients were randomized to receive placebo or to one of three dose levels of ADS-5102. As previously reported, ADS-5102 at 340 mg/day significantly reduced LID as measured by change in UDysRS over eight weeks versus placebo (primary endpoint, p=0.005). Data also suggested that ADS-5102 was generally well tolerated and reported adverse events were consistent with Parkinson’s disease and the known amantadine safety profile.Ongoing Phase 3 StudiesEASE LID, a confirmatory Phase 3 study, enrolled approximately 120 patients. The 26-week multi-center, randomized, double-blind, placebo-controlled study will assess 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 changes in UDysRS at week 12.EASE LID 3, a confirmatory Phase 3 study, as described above.EASE LID 2, an open-label safety study, which is open to patients from EASED, EASE LID and EASE LID 3, as well as LID patients who have undergone deep brain stimulation.Parkinson’s Disease and Levodopa-induced Dyskinesia
Parkinson’s disease is a chronic, progressive motor disorder that causes a variety of symptoms, such as tremors, rigidity, slowed movements and postural instability. The most commonly prescribed treatments for Parkinson’s disease are levodopa-based therapies. In the body, levodopa is converted to dopamine to replace the dopamine loss caused by the disease. Patients initially receive relief from symptoms of Parkinson’s disease for much of the day. This period of relief is known as ON time. As the effects of levodopa wear off, the symptoms of Parkinson’s disease return. This is known as OFF time.
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