Phase 3 Trial of ADS-5102 Recruiting Participants of All MS Types
A Phase 3 trial testing ADS-5102 (amantadine) extended release capsules in all types of multiple sclerosis (MS) is enrolling participants to determine whether the oral therapy can improve walking speed.
A total of 570 adults with MS, ages 18 to 70 years, who have difficulty walking will be recruited for the randomized trial (NCT03436199) at multiple sites across the U.S.
ADS-5102, marketed by Adamas Pharmaceuticals under the brand name Gocovri, was approved by the U.S. Food and Drug Administration in August 2017 to treat levodopa-induced dyskinesia, which refers to involuntary and jerky movements experienced by people with Parkinson’s disease receiving levodopa-based therapy.
The Adamas-sponsored study in MS patients is assessing the effectiveness and safety of two ADS-5102 doses — 137 and 274 mg — given once daily at bedtime for 21 weeks, compared with placebo.
The primary goal is to measure changes at 12 weeks in the Timed 25-Foot Walk test (T25FW), in which patients are instructed to walk 25 feet as quickly and safely as possible. Secondary measures, also at 12 weeks, include the Timed Up and Go (TUG) test of mobility and balance, and the Two-minute Walk Test.
To be eligible, patients need to be on a stable medication regimen for at least 30 days before screening, which must remain stable throughout the study. Exclusion criteria include intolerance to amantadine in the past, having an MS relapse less than 30 days before screening, or using Ampyra (dalfampridine) — a therapy by Acorda Therapeutics for adults with MS-related walking difficulties — or amantadine within 30 days prior to screening.
The trial, which recruited its first patient in April 2018, is set to conclude by September this year.
For more information on enrollment criteria, please visit the following trial’s webpage, or contact [email protected]. More information on study locations and contacts can be found here, or in a National MS Society press release.
Treatment with ADS-5102 was associated with improved walking speed in a four-week, double-blind Phase 2 trial (NCT02471222) in 60 MS patients with walking issues. ADS-5102, given at 137 mg in the first week and 274 mg in subsequent weeks, significantly improved T25FW scores by 16.6%, compared with placebo, and resulted in a 20% or greater improvement in walking speed in a greater proportion of patients than the control group.
Findings also showed a 10% improvement in TUG scores. The most common adverse events were dry mouth, constipation, and insomnia. Five of the 30 patients initially on the therapy discontinued treatment due to adverse events.