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news.US-based Adamas Pharmaceuticals has started a Phase II clinical trial with ADS-5102 (amantadine HCl) to treat people with multiple sclerosis (MS) who have walking impairment.
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Around 60 individuals will be included in this multi-center, randomized, double-blind, placebo-controlled, two arm, parallel group Phase II trial of ADS-5102.
During the trial, all patients will be on a stable regimen of MS medications for at least 30 days prior to screening and will continue the same dose and regimen for the duration of their study participation.
Adamas Pharmaceuticals chairman and CEO Gregory Went said: "We are pleased to initiate this Phase II trial in MS patients with walking impairment to further our understanding of the safety and tolerability of ADS-5102 and to obtain data to guide our development efforts.
"As our Phase III trials of ADS-5102 in levodopa-induced dyskinesia continue to move forward, we are identifying additional indications that will allow us to leverage our wholly-owned, extended-release formulation of amantadine and bring new treatment options to individuals in need."
The trial’s primary objective is to evaluate the safety and tolerability of ADS-5102 dosed at 340mg once daily at bedtime in an MS population, while efficacy measurements will include assessments of walking and fatigue.
The treatment duration in the trial will be four weeks and the top-line results are expected to be reported in 2016.
The company’s ADS-5102 is a high dose, extended-release version of amantadine that is administered once daily at bedtime
Initially, the company is developing ADS-5102 to treat levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease (PD).