NCT03505099

A Global Study of a Single, One-Time Dose of AVXS-101 Delivered to Infants With Genetically Diagnosed and Pre-symptomatic Spinal Muscular Atrophy With Multiple Copies of SMN2

Study Summary

To evaluate the safety and efficacy of intravenous onasemnogene abeparvovec-xioi in pre-symptomatic patients with SMA and 2 or 3 copies SMN2

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Interventions

onasemnogene abeparvovec-xioiBIOLOGICAL
A non-replicating recombinant AAV9 containing the complimentary deoxyribonucleic acid (cDNA) of the human SMN gene under the control of the cytomegalovirus (CMV) enhancer/chicken-β-actin-hybrid promoter (CB). The AAV inverted terminal repeat (ITR) has been modified to promote intramolecular annealing of the transgene, thus forming a double-stranded transgene ready for transcription.

Study Locations

FacilityCityStateCountry
David Geffen School of Medicine at UCLALos AngelesCaliforniaUnited States
Children's Hospital ColoradoAuroraColoradoUnited States
Nemours Children's HospitalOrlandoFloridaUnited States
Massachusetts General HospitalBostonMassachusettsUnited States
Helen DeVos Children's HospitalGrand RapidsMichiganUnited States
St. Louis Children's HospitalSt LouisMissouriUnited States
Columbia University Medical CenterNew YorkNew YorkUnited States
Nationwide Children's HospitalColumbusOhioUnited States
Clinic for Special ChildrenStrasburgPennsylvaniaUnited States
Children's Medical Center DallasDallasTexasUnited States
University Hospital and UW Health ClinicsMadisonWisconsinUnited States
Sydney Children's HospitalRandwickNew South WalesAustralia
Centre Hospitalier Régional Hôpital La CitadelleLiègeBelgium
Canada Childrens Hospital of Eastern OntarioOttawaOntarioCanada
Tokyo Women's MedicalTokyoJapan
Great Ormond Street Hospital for Children NHS Foundation TrustLondonUnited Kingdom

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026