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Extension Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Who Previously Participated in a Study With Nusinersen
Recruiting
Trial ID: NCT04729907
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
Stanford Investigator(s)
John W. Day, MD, PhD
Professor of Neurology (Adult Neurology), of Pediatrics (Genetics) and, by courtesy, of Pathology
Eligibility
Key Inclusion Criteria:
- Completed the Day 302 visit in study 232SM203 (NCT04089566) in accordance with the
study protocol
Key Exclusion Criteria:
- 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.
Intervention(s):
drug: Nusinersen
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305