Long-term Follow-up of Patients With Spinal Muscular Atrophy Treated With OAV101 in Clinical Trials
Long-term Follow-up of Patients With Spinal Muscular Atrophy Treated With OAV101 IT or OAV101 IV in Clinical Trials
ClinicalTrials.gov Identifier: NCT05335876
Novartis Reference Number: COAV101A12308
Last Update: Feb 08, 2023
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
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.
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.
There are no exclusion criteria for this study.