A Phase 3, Randomized, Double-blind, Sham-Procedure Controlled Study to Assess the Clinical Efficacy and Safety of ISIS 396443 Administered Intrathecally in Patients With Later-onset Spinal Muscular Atrophy

Trial Profile

A Phase 3, Randomized, Double-blind, Sham-Procedure Controlled Study to Assess the Clinical Efficacy and Safety of ISIS 396443 Administered Intrathecally in Patients With Later-onset Spinal Muscular Atrophy

Discontinued
Phase of Trial: Phase III

Latest Information Update: 30 Sep 2017

At a glance

  • Drugs Nusinersen (Primary)
  • Indications Spinal muscular atrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms CHERISH
  • Sponsors Ionis Pharmaceuticals
  • Most Recent Events

    • 01 Jun 2017 According to an Ionis Pharmaceuticals media release, based on the data from ENDEAR and CHERISH trials,including results from open label studies in pre-symptomatic and symptomatic individuals with, or most likely to develop, Types 1, 2 or 3 SMA ,the European Commission (EC) has granted marketing authorization for SPINRAZA (nusinersen) for the treatment of 5q spinal muscular atrophy (SMA).
    • 17 May 2017 This trial has been completed in Sweden (end date: 20 Feb 2017).
    • 09 May 2017 According to a Ionis Pharmaceuticals media release, data from the study was presented at the American Academy of Neurology (AAN) annual meeting.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top