Status:
RECRUITING
Long-term Follow-up of Patients With Spinal Muscular Atrophy Treated With OAV101 in Clinical Trials
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Spinal Muscular Atrophy (SMA)
Eligibility:
All Genders
Up to 100 years
Phase:
PHASE3
Brief Summary
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 sa...
Detailed Description
The study is comprised of a Baseline Visit and 2 Follow-up Periods. For Follow-up Periods 1 and 2, which includes Baseline through Year 5 visits, assessments will be performed at the Investigational s...
Eligibility Criteria
Inclusion
- 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
- There are no exclusion criteria for this study.
Key Trial Info
Start Date :
December 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 26 2030
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT05335876
Start Date
December 19 2022
End Date
June 26 2030
Last Update
December 10 2024
Active Locations (29)
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1
Child Hosp Of The Kings Daughters
Norfolk, Virginia, United States, 23507
2
Novartis Investigative Site
Randwick, New South Wales, Australia, 2031
3
Novartis Investigative Site
Leuven, Belgium, 3000
4
Novartis Investigative Site
Montreal, Quebec, Canada, H4A 3J1