RecruitingPhase 3

Long-term Follow-up of Patients With Spinal Muscular Atrophy Treated With OAV101 in Clinical Trials

United States, Australia, Belgium175 participantsStarted 2022-12-19

Plain-language 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 safety and efficacy in Study COAV101A12308 will continue for 5 years after enrollment in this study.

Who can participate

Age range0 Years – 100 Years

SexALL

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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.

What they're measuring

Number of participants with treatment-emergent serious adverse events (SAEs)

Timeframe: Up to Year 5

Number of participants with treatment emergent Adverse Events of Special Interest (AESI)

Timeframe: Up to Year 5

Trial details

NCT IDNCT05335876

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2030-09-26

Contact for this trial

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

View on ClinicalTrials.gov More Spinal Muscular Atrophy (SMA) trials