The first patient has been enrolled in Adamas Pharmaceuticals ’ pivotal Phase III clinical trial of ADS-5102 (amantadine) extended release capsules to treat multiple sclerosis (MS ) patients with walking impairment.
The three-arm, randomised study will enrol up to 540 MS patients with walking impairment across the US.
Its primary endpoint is evaluating the efficacy of a once-daily 274mg dose of ADS-5102 given at bedtime to MS patients with walking impairment as measured by the Timed 25-foot Walk (T25FW, feet/second) at week 12.
Secondary endpoints of the trial include analysing the efficacy of 274mg of ADS-5102 in MS patients with walking impairment as measured by the Timed Up and Go (TUG) test, and the Two-Minute Walk Test (2MWT) at week 12.
The efficacy of a 137mg dose of ADS-5102, administered once-daily at bedtime in MS patients with walking impairment as measured by the T25FW, the TUG test, and the 2MWT at week 12 has also been included as a secondary endpoint of the trial.
ADS-5102 is a high-dose amantadine taken once-daily at bedtime. It was previously approved by the US Food and Drug Administration (FDA) under the trade name GOCOVRI (amantadine) for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications.
Adamas Pharmaceuticals chief medical officer Rajiv Patni said: “Initiating this Phase III 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.
“The goal of the study is to confirm the results of our Phase II proof-of-concept study and to demonstrate the efficacy and safety of ADS-5102 using several measures of walking in MS patients.”
According to the trial’s steering committee member Aaron Miller, around half of MS patients have become dependent on some form of walking aid after 15 years as a result of their underlying disease.