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A Two-part, Phase 3 Dose Response Study to Assess the Safety and Efficacy of Nabiximols Oromucosal Spray (Sativex) in the Symptomatic Relief of Spasticity in Subjects With Spasticity Due to Multiple Sclerosis

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Trial Profile

A Two-part, Phase 3 Dose Response Study to Assess the Safety and Efficacy of Nabiximols Oromucosal Spray (Sativex) in the Symptomatic Relief of Spasticity in Subjects With Spasticity Due to Multiple Sclerosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Jun 2022

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At a glance

  • Drugs Nabiximols (Primary)
  • Indications Muscle spasticity
  • Focus Registrational; Therapeutic Use
  • Sponsors Jazz Pharmaceuticals Inc

Most Recent Events

  • 26 Apr 2022 Results of two studies (SAVANT and GWSP0604) assessing treatment outcomes for people with multiple sclerosis (PwMS) spasticity taking nabiximols with or without concomitant antispasticity medications (ASMs), such as baclofen, presented at the 74th Annual Meeting of the American Academy of Neurology 2022.
  • 26 Apr 2022 Results assessing treatment effect of nabiximols during each week of the double-blind, placebo-controlled portion of GWSP0604 and SAVANT using an equivalent statistical model, presented at the 74th Annual Meeting of the American Academy of Neurology 2022.
  • 15 Oct 2021 Results of a post hoc analysis assessing the treatment effect during each week of Part B of both studies (SAVANT and GWSP0604) presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis

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