Another finding was that more of the treated patients increased their walking speed by 20 percent or more during the four-week trial.
The study, “Safety and efficacy of ADS-5102 (amantadine) extended release capsules to improve walking in multiple sclerosis: A randomized, placebo-controlled, phase 2 trial,” was published in the Multiple Sclerosis Journal.
Adamas said the proof-of-concept trial (NCT02471222) at 14 U.S. centers involved 60 patients with walking impairments. Researchers randomized them so that 30 received ADS-5102 and 30 a placebo.
Patients took a tablet a day at bedtime. In the first week, participants received 137-mg tablets. After that, it was 274-mg doses.
The trial’s primary objective was to evaluate ADS-5102’s safety and patients’ ability to tolerate it. Secondary objectives included seeing if ADS-5102 would improve patients’ overall mobility and walking ability. Researchers used four measurements: Patients’ scores on a timed 25-foot walk test, timed up and go test, two-minute walk test, and MS walking scale 12.
Treated patients’ timed 25-foot walk test score was 16.6 percent higher than the placebo group’s — a result considered significant. The test covers both mobility and leg function performance.
In addition, treated patients fared better than the controls in the timed up and go and two-minute walk tests, “although the differences were not significant,” the researchers wrote. The up and go test uses balance to assess mobility. As the name two-minute walk test implies, it looks at the distance a person can walk in two minutes.
In terms of safety, patients generally tolerated ADS-5102 well, researchers said.
“In this proof-of-concept study, a greater proportion of ADS-5102 patients had at least a 20 percent improvement in walking speed compared with the placebo group,” Jeffrey A. Cohen, a Cleveland Clinic neurologist who was a consultant on the trial, said in a press release. Cohen is with the Cleveland Clinic’s Mellen Center for Multiple Sclerosis Treatment and Research.
“There is a need for additional, effective treatment options in this multiple sclerosis patient population, as currently there is only one FDA-approved drug, which is believed to be effective in only a subset of multiple sclerosis patients with walking impairment,” Cohen added.
Adamas plans to start a Phase 3 clinical trial this year of ADS-5102’s ability to help MS patients.
“We are pleased to have data from this important study available in a peer-reviewed journal and look forward to initiating the first Phase 3 clinical study of ADS-5102 in multiple sclerosis patients with walking impairment in the second quarter of 2018,” Rajiv Patni, the company’s chief medical officer.
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