Trial Profile
A 3-arm, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ADS-5102 Amantadine Extended Release Capsules in Multiple Sclerosis Patients With Walking Impairment
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 19 Apr 2022
Price :
$35
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At a glance
- Drugs Amantadine (Primary)
- Indications Movement disorders; Multiple sclerosis
- Focus Registrational; Therapeutic Use
- Acronyms INROADS
- Sponsors Adamas Pharmaceuticals
- 01 Apr 2022 Primary results published in the Multiple Sclerosis Journal
- 17 Jun 2020 According to an Adamas Pharmaceuticals media release, Further engagement with the U.S. Food and Drug Administration (FDA) to fully understand a potential path to submission confirmed the need for an additional pivotal Phase 3 confirmatory study. Based on these findings, Adamas reconfirms it will not initiate further Phase 3 development in MSW.
- 17 Jun 2020 According to an Adamas Pharmaceuticals media release, the company has carried out a comprehensive analysis of topline results from the trial and informed a revised target product profile reflecting the scale of clinical benefit observed in the study. Additional patient, physician, and payer research based on the revised profile projected a limited commercial opportunity.