Status:
ACTIVE_NOT_RECRUITING
A Study to Learn About the Long-Term Safety of Higher Doses of Nusinersen (BIIB058) Given as Injections to Participants With Spinal Muscular Atrophy (SMA) Who Took Part in an Earlier Nusinersen Trial (ONWARD)
Lead Sponsor:
Biogen
Conditions:
Muscular Atrophy, Spinal
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief Summary
In this study, researchers will learn more about the use of nusinersen (BIIB058) in participants with spinal muscular atrophy (SMA). This study is an extension study and will enroll only those partici...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Key
- Completed the Day 302 visit in study 232SM203 (NCT04089566) in accordance with the study protocol
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
April 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2026
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT04729907
Start Date
April 19 2021
End Date
July 31 2026
Last Update
February 3 2025
Active Locations (39)
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1
Stanford University Medical Center
Sacramento, California, United States, 94304
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
3
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611-260
4
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205