Phase
Condition
Muscular Dystrophy
Spinal Muscular Atrophy
Myasthenia Gravis (Chronic Weakness)
Treatment
No Intervention
Clinical Study ID
Ages 18-54 Female
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Participant who is currently pregnant (or was pregnant during the relevant exposurewindow) and enrolled in the United States (US) network of the ISMAR registry, theUnited Kingdom (UK) Adult SMA REACH, or the Germany, Austria, or Switzerland networkof the SMArtCARE registry
Genetic documentation of spinal muscular atrophy linked to chromosome 5q (5q SMA)
Documentation that the participant was exposed to nusinersen up to 14 months priorto the first day of their LMP before conception, 14.5 months before conception,and/or at any time during their pregnancy
Exclusion
Key Exclusion Criteria:
- Treatment with risdiplam at any time from the first day of their LMP, 2 weeks priorto the date of conception (approximately 5 half-lives), and/or plans to receivetreatment with risdiplam during pregnancy
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Study Design
Study Description
Connect with a study center
St George's University NHS Foundation Trust
London, Greater London SW17 0QT
United KingdomActive - Recruiting
The Northern Care Alliance NHS Foundation Trust
Salford, Greater Manchester M6 8HD
United KingdomActive - Recruiting
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire SO16 6YD
United KingdomActive - Recruiting
Nottingham University Hospitals Trust
Nottingham, Nottinghamshire NG5 1PB
United KingdomActive - Recruiting
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, Shropshire SY10 7AG
United KingdomActive - Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire S10 2SB
United KingdomActive - Recruiting
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne And Wear NE7 7ND
United KingdomActive - Recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands B15 2GW
United KingdomActive - Recruiting
North Bristol NHS Trust
Bristol, BS10 5NB
United KingdomActive - Recruiting
Research Site
Cambridge, Massachusetts 02142
United StatesSite Not Available
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