Adamas Therapy Improves Multiple Sclerosis Patients’ Walking Speed, Trial Shows

Adamas Therapy Improves Multiple Sclerosis Patients’ Walking Speed, Trial Shows
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The walking speed of multiple sclerosis patients taking Adamas Pharmaceuticals’ ADS-5102 (amantadine) increased by 16.6 percent more those taking a placebo, a Phase 2 clinical trial reports.

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.

Patricia holds her Ph.D. in Cell Biology from University Nova de Lisboa, and has served as an author on several research projects and fellowships, as well as major grant applications for European Agencies. She also served as a PhD student research assistant in the Laboratory of Doctor David A. Fidock, Department of Microbiology & Immunology, Columbia University, New York.
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Patricia holds her Ph.D. in Cell Biology from University Nova de Lisboa, and has served as an author on several research projects and fellowships, as well as major grant applications for European Agencies. She also served as a PhD student research assistant in the Laboratory of Doctor David A. Fidock, Department of Microbiology & Immunology, Columbia University, New York.
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