Date: 2014-11-12
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Adamas Pharmaceuticals (USA - CA)
Product: ADS-5102
Action
mechanism: ADS-5102, an investigational agent, is a high dose, controlled-release version of amantadine HCl administered once daily at bedtime.
Disease: levodopa-induced dyskinesia (LID) in patients with Parkinson\'s disease
Therapeutic area: Neurodegenerative diseases - CNS diseases
Country: USA, Europe
Trial
details: EASE LID 3 is one of three ongoing clinical trials for the treatment of LID in individuals with Parkinson\'s disease. The complete company-sponsored program includes: EASE LID 3, a Phase 3 study, which is estimated to enroll approximately 70 patients. The 13-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.
EASE LID, a Phase 3 trial, which is planned to enroll approximately 130 patients. The 26-week multi-center, randomized, double-blind, placebo-controlled trial 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.
EASE LID 2, a Phase 3 open-label safety study of ADS-5102 in Parkinson\'s disease patients with LID.
EASED, a Phase 2/3 study that enrolled 83 patients. The 8-week, multi-center, randomized, double-blind, placebo-controlled trial assessed the efficacy of three dose levels of ADS-5102 administered once daily at bedtime. The study met its primary endpoint, which was a reduction in dyskinesia assessed by changes in UDysRS.
Latest
news: * On October 28, 2014, Adamas Pharmaceuticals announced that it has initiated an additional Phase 3 safety and efficacy study evaluating ADS-5102 for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson\'s disease. The randomized, double-blind, placebo-controlled study, known as \"EASE LID 3,\" is planned to enroll approximately 70 patients with LID. The 13-week study will include an estimated 35 sites in the US and Europe. Participants will receive 340 mg of ADS-5102 or placebo daily. The primary endpoint of EASE LID 3 is a reduction in dyskinesia assessed by changes in the Unified Dyskinesia Rating Scale (UDysRS). Additional supporting data will be obtained from the secondary endpoints, including changes in \"ON\" time without troublesome dyskinesia, \"OFF\" time, and the Unified Parkinson\'s Disease Rating Scale (MDS-UPDRS) and sub scores. The complete company-sponsored program includes four phase 3 studies. Adamas Pharmaceuticals anticipates completing enrollment in all of these studies in 2015, enabling the company to achieve a planned NDA submission in 2016.
