An Extension Study to Evaluate Casimersen or Golodirsen in Patients With Duchenne Muscular Dystrophy
Sponsor: Sarepta Therapeutics, Inc.
Sommario: The main objective of this study is to evaluate the safety and tolerability of long-term treatment with casimersen or golodirsen in patients with Duchenne muscular dystrophy (DMD).
TIPOLOGIA STUDIO
Interventistico
FASE
Fase 3
TRATTAMENTO
- Casimersen
- Golodirsen
OBIETTIVO PRIMARIO
- Misura: Number of Patients With Serious Adverse Events (SAEs)
- Tempo: Up to 30 days after the last infusion of study drug (assessed up to 148 weeks)
- Descrizione:
CRITERI DI ELIGIBILITA'
-
Criteri di inclusione e esclusione
Inclusion Criteria: - Completed a clinical trial evaluating casimersen or golodirsen, per protocol. - Is between 7 and 23 years of age, inclusive, at enrollment. Other inclusion/exclusion criteria apply.
SESSO
Maschi
ETA' MINIMA
Età Minima: 7 Years
Età Massima: 23 Years
LUOGO
UOSD Centro Traslazionale di Miologia e Patologie Neurogenerative
Genova, 16147
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna
Cona, 44124
Fondazione Policlinico Universitario A Gemelli
Milano, 20123