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A Phase 2, Randomized, Double-blind, Sham-procedure Controlled Study to Assess the Safety and Tolerability and Explore the Efficacy of ISIS 396443 (BIIB058) Administered Intrathecally in Subjects With Spinal Muscular Atrophy Who Are Not Eligible to Participate in the Clinical Studies ISIS 396443-CS3B or ISIS 396443-CS4

Trial Profile

A Phase 2, Randomized, Double-blind, Sham-procedure Controlled Study to Assess the Safety and Tolerability and Explore the Efficacy of ISIS 396443 (BIIB058) Administered Intrathecally in Subjects With Spinal Muscular Atrophy Who Are Not Eligible to Participate in the Clinical Studies ISIS 396443-CS3B or ISIS 396443-CS4

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 12 Sep 2023

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At a glance

  • Drugs Nusinersen (Primary)
  • Indications Spinal muscular atrophy
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms EMBRACE
  • Sponsors Biogen
  • Most Recent Events

    • 01 May 2021 Results assessing safety and efficacy of nusinersen in spinal muscular atrophy published in the Muscle and Nerve
    • 24 Jan 2020 Status changed from completed to discontinued.
    • 29 Jun 2019 According to a Biogen media release, the company announced an update to the European label for nusinersen, incorporating longer-term data from four studies (NURTURE, EMBRACE, SHINE and CS3A). These studies, which looked at pre-symptomatic, infantile-onset and later-onset treatment, further confirm the benefits of early treatment and durability of treatment effect of nusinersen. No new safety concerns were identified.
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