A Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ISIS 396443 Delivered Intrathecally to Patients With Infantile-Onset Spinal Muscular Atrophy
Phase of Trial: Phase II
Latest Information Update: 29 Jun 2019
At a glance
- Drugs Nusinersen (Primary)
- Indications Spinal muscular atrophy
- Focus Therapeutic Use
- Sponsors Biogen; Ionis Pharmaceuticals
- 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.
- 06 Nov 2017 Status changed from active, no longer recruiting to completed.
- 28 Jul 2017 Planned End Date changed from 1 Jun 2017 to 31 Aug 2017.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History