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A Study of Spinraza (Nusinersen) Exposure in Pregnant Women With Spinal Muscular Atrophy (SMA) Within Existing SMA Registries

Muscular Atrophy, Spinal Clinical Trial

Official title:
Spinraza (Nusinersen) SMA Pregnancy Exposure Study Within Existing SMA Registries

Clinical Trial Summary

The primary objectives of the study are to prospectively evaluate pregnancy complications and outcomes in participants with SMA, birth outcomes and adverse effects in infants born to participants with SMA, who were exposed to nusinersen up to 14 months prior to the first day of their last menstrual period (LMP) before conception, 14.5 months before the date of conception, and/or at any time during their pregnancy. The secondary objective of the study is to evaluate pregnancy outcomes in participants with SMA exposed to nusinersen as compared with participants without SMA who were not exposed to nusinersen (e.g., participants from external, general population comparators).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05789758
Study type Observational [Patient Registry]
Source Biogen
Contact US Biogen Clinical Trial Center
Phone 866-633-4636
Email clinicaltrials@biogen.com
Status Recruiting
Phase
Start date December 15, 2023
Completion date October 31, 2033
View Details
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