Long-term Follow-up of Patients With Spinal Muscular Atrophy Treated With OAV101 in Clinical Trials
About the study
This is a global, prospective, multi-center study that is designed to assess the long-term safety and efficacy of OAV101 in patients who participated in an OAV101 clinical trial. The assessments of safety and efficacy in Study COAV101A12308 will continue for 15 years from the date of OAV101 administration in the parent study.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Participated in an OAV101 clinical trial.
- Written informed consent must be obtained before any assessment is performed.
- Patient/Parent/legal guardian willing and able to comply with study procedures.
EXCLUSION CRITERIA
Exclusion Criteria:
There are no exclusion criteria for this study.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Spinal Muscular Atrophy (SMA)
Phase
Phase 3
Participants needed
260
Est. Completion Date
Oct 18, 2039
Treatment type
Interventional
Sponsor
Novartis
ClinicalTrials.gov identifier
NCT05335876
Study number
COAV101A12308
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