A Phase 3 trial testing an oral once-a-day therapy — ADS-5102 (amantadine) extended release capsules — in multiple sclerosis (MS) patients with walking difficulties has enrolled its first participant, Adamas Pharmaceuticals announced.
The multi-center, double-blind study (NCT03436199) will assess ADS-5102 in about 570 such patients at five sites across the U.S. Eligible patients are being recruited at sites in Colorado, Georgia, New York, North Carolina and Washington.
Researchers will test the efficacy of two doses, 274 mg or 137 mg, of ADS-5102 given at bedtime against each other and against a placebo. Effectiveness will be analyzed as a primary goal using the timed 25-foot walk (T25FW) test — a measure of mobility and leg function — at week 12. Changes in the Timed Up and Go (TUG) test — a measure of mobility — and in the 2-Minute Walk Test (2MWT) will also be assessed.
Amantadine extended release capsules, marketed by Adamas under the trade name Gocovri, were approved by the U.S. Food and Drug Administration in August 2017 to treat the uncontrolled jerky movements that affect Parkinson’s patients on levodopa-based therapy.
“Initiating this Phase 3 study of ADS-5102 in MS patients with walking impairment is a significant milestone for Adamas, as it could potentially advance the approval of Gocovri (amantadine) extended release capsules as a treatment for this MS population,” Rajiv Patni, chief medical officer at Adamas, said in a press release.
It is set to conclude in September 2019; enrollment and other information is available by clicking here.
“The goal of the study is to confirm the results of our Phase 2 proof-of-concept study and to demonstrate the efficacy and safety of ADS-5102 using several measures of walking in MS patients,” Patni added.
The Phase 2 trial (NCT02471222) compared treatment with ADS-5102 against placebo in a total of 60 MS patients with walking impairments. ADS-5102 was given at a 137 mg dose in the first week and at 274 mg dose in subsequent weeks.
Results showed that ADS-5102 significantly improved T25FW scores in patients by 16.6 percent, and led to at least a 20 percent improvement in walking speed in a greater proportion of patients compared to placebo.
These data were reported in 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,“ published in the Multiple Sclerosis Journal.
“Approximately half of MS patients become dependent on some form of walking aid after 15 years due to their underlying disease,” said Aaron Miller, MD, a member of trial’s steering committee.
Miller is also medical director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai, in New York.
“There is a significant unmet medical need for additional therapies to treat impaired mobility in MS as the current approved treatment option, for this critically important function, is demonstrated to not be effective for a majority of patients,” he concluded.
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