Results from a Phase 2 proof-of-concept study of ADS-5102 (amantadine HCl), showing that multiple sclerosis patients given the extended-release oral treatment improved their walking speed, will be presented at ACTRIMS 2017 this week.
Findings in the poster, “A Phase 2 Study of ADS-5102 (amantadine hydrochloride) Extended Release Capsules in Multiple Sclerosis Patients with Walking Impairment,” will be discussed at the forum by Dr. Jeffrey Cohen, director of the Cleveland Clinic’s Mellen Center for Multiple Sclerosis Treatment and Research, on Feb. 23, the drug’s developer, Adamas Pharmaceuticals, announced. (ACTRIMS is short for the Americas Committee for Treatment and Research in Multiple Sclerosis.)
The four-week clinical trial (NCT02471222) was a multi-center, randomized, double-blind, placebo-controlled study of ADS-5102 (340 mg capsule) given once daily at bedtime to 60 MS patients. The company reported a number of positive outcomes, including safety — the trial’s primary endpoint — in June.
Secondary goals looked at improvement in walking ability, as assessed by a timed 25-foot walk (T25FW), Timed Up and Go (TUG) test, a 2-Minute Walk test, and the MS Walking Scale-12. Results showed a 17 percent placebo-adjusted improvement in walking speed in the T25FW test, and about a three-second placebo-adjusted improvement in the TUG test, Adamas reported.
No effects were seen in fatigue, depression or cognitive dysfunction, other MS symptoms that were also evaluated. ADS-5102 was well-tolerated by treated patients, who remained on other MS medications throughout the study.
“This Phase 2 proof-of-concept study of ADS-5102 has generated encouraging data across several performance measures in multiple sclerosis patients,” Rajiv Patni, MD, chief medical officer of Adamas, said in a press release. “If these data are confirmed in longer duration, controlled clinical trials, ADS-5102 may offer an additional treatment option for multiple sclerosis patients experiencing impairments in walking ability, which are issues that a large number of patients with multiple sclerosis confront.”
One serious adverse event, suspected serotonin syndrome, was reported in a treated patient, but the most common side effects were insomnia, dry mouth, and constipation. Five people taking ADS-5102 discontinued treatment due to adverse events; no placebo group patients stopped participating.
ADS-5102 is also being evaluated as a potential treatment of levodopa-induced dyskinesia associated with Parkinson’s disease. Amantadine, an oral drug that was originally approved by the U.S. Food and Drug Administration (FDA) to treat the influenza A virus, is also used to treat symptoms of Parkinson’s.