A Randomized, Double-Blind, Parallel Group Study to Compare the Safety and Efficacy Arbaclofen ER Tablets to Placebo and Baclofen Tablets, USP for the Treatment of Spasticity in Patients With Multiple Sclerosis

Trial Profile

A Randomized, Double-Blind, Parallel Group Study to Compare the Safety and Efficacy Arbaclofen ER Tablets to Placebo and Baclofen Tablets, USP for the Treatment of Spasticity in Patients With Multiple Sclerosis

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Sep 2016

At a glance

  • Drugs Arbaclofen (Primary) ; Baclofen
  • Indications Muscle spasticity
  • Focus Registrational; Therapeutic Use
  • Sponsors Osmotica Pharmaceutical
  • Most Recent Events

    • 21 Apr 2016 Results (n=354) presented at the 68th Annual Meeting of the American Academy of Neurology.
    • 28 Sep 2015 According to Osmotica Pharmaceutical media release, the US FDA has accepted for filing a New Drug Application (NDA) for arbaclofen extended release tablet formulation (Ontinua) for alleviation of spasticity associated with multiple sclerosis.
    • 27 May 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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