Adamas Pharmaceuticals, Inc., a specialty pharmaceutical company developing therapies for chronic disorders of the central nervous system, recently announced the beginning of a Phase 2 study that will assess the efficacy of amantadine HCl (ADS-5102) in patients with a diagnosis of multiple sclerosis (MS) who suffer from walking impairments.
“We are pleased to initiate this Phase 2 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,” said in a recent news release Gregory T. Went, Ph.D., Chairman and CEO of Adamas Pharmaceuticals, Inc. “As our Phase 3 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 is a Phase 2 randomized, multi-center, placebo-controlled, double-blind, two-arm, parallel group clinical trial that will assess the efficacy of the company ADS-5102 in a total of 60 patients with a diagnosis of MS who suffer from walking impairments.
Adamas’ most advanced wholly-owned product candidate is ADS-5102 (amantadine HCl), a high dose, extended-release version of amantadine that is administered once daily at bedtime.
All patients will receive a drug regimen for a period of 30 days before being screened, and will continue with the same regimen and dose while taking part in the trial. The clinical trial’s primary endpoint is to assess the tolerability and safety of the drug ADS-5102 at a dose 340 mg once per day at bedtime. The researchers will assess fatigue and walking as efficacy measures. The duration of the treatment will be for a period of 1 month and the company is expecting to have top-line results of the trial in 2016.
Multiple sclerosis (MS) is a disease that affects both the brain as well as the spinal cord. Early symptoms of the disease include difficulties in walking that are often the result of muscle weakness, tingling, numbness, and muscle stiffness. If ADS-5102 proves successful, it could offer MS patients a viable treatment for mitigating walking impairments caused by the disease.