Extension Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Who Previously Participated in a Study With Nusinersen

Trial ID or NCT#

NCT04729907

Status

recruiting iconRECRUITING

Purpose

The primary objective of this study is to evaluate the long-term safety and tolerability of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA) who previously participated in study 232SM203 (NCT04089566). The secondary objective of this study is to evaluate the long-term efficacy of nusinersen administered intrathecally at higher doses to participants with SMA who previously participated in study 232SM203 (NCT04089566).

Official Title

A Long-Term Extension Study of Nusinersen (BIIB058) Administered at Higher Doses in Participants With Spinal Muscular Atrophy Who Previously Participated in an Investigational Study With Nusinersen

Eligibility Criteria

Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Completed the Day 302 visit in study 232SM203 (NCT04089566) in accordance with the study protocol Key
Exclusion Criteria:
  1. - Treatment with another investigational therapy or enrollment in another interventional clinical study - Treatment with an approved therapy for SMA after the Day 302 Visit of Study 232SM203 (NCT04089566) NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
View All Criteria
Show Less

Investigator(s)

John W. Day, MD, PhD
John W. Day, MD, PhD
Neuromuscular neurologist, Neurophysiologist
Professor of Neurology (Adult Neurology), of Pediatrics (Genetics) and, by courtesy, of Pathology

View on ClinicalTrials.gov