Adamas Pharmaceuticals announced the study design and baseline characteristics of patients enrolling in the company’s ongoing Phase 3 trial testing the efficacy and safety of ADS-5102 (amantadine) extended-release capsules in patients with multiple sclerosis (MS) who have difficulty walking.
The data were presented in a poster, titled “INROADS: A Phase 3 Study to Assess the Efficacy and Safety of ADS-5102 (Amantadine) Extended Release Capsules in Multiple Sclerosis (MS) Patients with Walking Impairment,” at the American Academy of Neurology (AAN) Annual Meeting, taking place through May 10 in Philadelphia.
ADS-5102 (marketed under the brand name Gocovri by Adamas) was approved by the U.S. Food and Drug Administration in August 2017 for the treatment of involuntary muscle twitching (dyskinesia) in patients with Parkinson’s disease receiving levodopa-based therapies.
Now, the company’s ongoing multicenter, randomized, double-blind, placebo-controlled Phase 3 INROADS trial (NCT03436199) is confirming the therapeutic potential of ADS-5102 in a larger group of MS patients who have difficulty walking. The study is continuing to recruit participants; more information on contacts and locations is available here.
The 16-week INROADS trial will test the safety and effectiveness of two doses of ADS-5102 (137 and 274 mg), taken orally once a day at bedtime, compared with a placebo, according to an Adamas press release.
The trial’s primary objective is changes in the timed 25-foot walk test, which measures how quickly patients are able to walk 25 feet, from study start (baseline) to 16 weeks after treatment.
In March 2018, the first patient was enrolled in the trial. As of October 2018, a total of 93 MS patients had been assigned to their treatment groups. Patient ages range from 35 to 70 years old (mean of 55.6 years old), and they have a disease duration from 0.4 to 43 years (mean of 17.1 years).
Most patients (72%) enrolled in the study have relapsing-remitting MS. More than half (52.7%) have already been treated with Ampyra (dalfampridine) — a therapy marketed by Acorda Therapeutics and approved by the FDA in January 2010 to improve walking in MS patients — while 16.1% have been treated with immediate-release amantadine.
At baseline, participants had a median score of six points on the Expanded Disability Status Scale, indicating moderate walking impairment.
If the study is successful, Adamas plans to schedule a meeting with the FDA to confirm the filing requirements for a supplemental new drug application for ADS-5102. This application allows companies or sponsors to formally request the approval of a new therapy for sale and marketing in the U.S.