NCT05861986

A Phase IV Open-Label Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Patients With Spinal Muscular Atrophy After Gene Therapy

Study Summary

This is an open-label, single-arm, multicenter clinical study to evaluate the effectiveness and safety of risdiplam administered as an early intervention in pediatric participants with spinal muscular atrophy (SMA) and 2 SMN2 copies who have previously received onasemnogene abeparvovec. Participants are children \< 2 years of age genetically diagnosed with SMA.

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Interventions

RisdiplamDRUG
Participants will receive risdiplam orally at the currently approved dose. The dose should be adapted for weight and age.

Study Locations

FacilityCityStateCountry
University of Arkansas for Medical SciencesLittle RockArkansasUnited States
Children's Hospital of ColoradoAuroraColoradoUnited States
University of Florida PediatricsGainesvilleFloridaUnited States
Children's Healthcare of Atlanta Center for Advanced PediatricsAtlantaGeorgiaUnited States
Ann and Robert H. Lurie Children Hospital of ChicagoChicagoIllinoisUnited States
Helen DeVos Children's Hospital at Spectrum HealthGrand RapidsMichiganUnited States
Columbia University Medical CenterNew YorkNew YorkUnited States
Children'S Hospital of PhiladelphiaPhiladelphiaPennsylvaniaUnited States
The University of Texas Southwestern Medical Center at DallasDallasTexasUnited States
Cook Children's Jane and John Justin Neurosciences CenterFort WorthTexasUnited States
Children's Hospital of the King's DaughterNorfolkVirginiaUnited States
Charité - Universitätsmedizin Berlin SPZ Abteilung NeuropaediatrieBerlinGermany
UKGM Standort GießenGiessenGermany
Uniwersyteckie Centrum KliniczneUniwersyteckie Centrum KlinicznePoland
Instytut Pomnik Centrum Zdrowia DzieckaWarsawPoland
Great Ormond Street Hospital For ChildrenLondonUnited Kingdom

Official Trial Information

View on ClinicalTrials.gov

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