Adamas Pharmaceuticals, has initiated a pivotal Phase 3 clinical study of ADS-5102 (amantadine HCl), a high-dose, controlled-release version of amantadine for the treatment of patients with Parkinson's disease who have developed levodopa-induced dyskinesia (LID). LID is a condition characterised by involuntary movements without purpose that can become severely disabling, rendering individuals with Parkinson's disease unable to perform routine daily tasks.
The Phase 3 study (EASE LID) will enroll approximately 130 patients. It is a 26-week multi-centre, randomised, double-blind, placebo-controlled trial, which will assess the efficacy of a once daily 340 mg dose of ADS-5102 administered at bedtime for the treatment of LID in individuals with Parkinson's disease. The primary endpoint of EASE LID is a reduction in LID as assessed by changes in the Unified Dyskinesia Rating Scale (UDysRS) along with supporting data from secondary endpoints.
Adamas' most advanced wholly-owned product candidate is ADS-5102 (amantadine HCl), a high dose, controlled-release version of amantadine, that is administered once daily at bedtime. Adamas is initially developing ADS-5102 for the treatment of levodopa-induced dyskinesia, or LID in patients with Parkinson's disease. LID is a movement disorder that frequently occurs in patients after long-term treatment with levodopa, the most widely used drug for Parkinson's disease. There are no approved drugs for the treatment of LID in the United States or Europe. Adamas is also evaluating ADS-5102 as a potential treatment for chronic behavioural symptoms associated with traumatic brain injury, or TBI.