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

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 09 May 2017

At a glance

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

    • 24 Feb 2017 Planned primary completion date changed from 1 Jan 2018 to 1 Apr 2019.
    • 23 Dec 2016 Planned End Date changed from 1 Jan 2018 to 1 Apr 2019.
    • 09 Jun 2016 Time frame of the primary end point changed from 14 months overall to q4 months for part 1 and 30 months to part 2.
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