Overview of idebenone (SNT-MC17; Raxone) clinical trials

Idebenone (SNT-MC17; Raxone)

Phase IIa placebo controlled study (NCT00654784) and open label extension study (NCT00758225)

Efficacy and Tolerability of Idebenone in Boys With Cardiac Dysfunction Associated With Duchenne Muscular Dystrophy (DELPHI)

Long-term Safety, Tolerability and Efficacy of Idebenone in Duchenne Muscular Dystrophy (DELPHI Extension)

  • Buyse GM, Goemans N, van den Hauwe M, et al. Idebenone as a novel, therapeutic approach for Duchenne muscular dystrophy: results from a 12 month, double-blind, randomized placebo-controlled trial. Neuromuscular disorders : NMD 2011;21:396-405

Buyse_2011_Neuromuscul Disord. Jun;21(6);396-405

  • Buyse GM, Goemans N, van den Hauwe M, Meier T. Effects of glucocorticoids and idebenone on respiratory function in patients with duchenne muscular dystrophy. Pediatric pulmonology 2013;48:912-20

Phase III placebo controlled study (NCT01027884)

Phase III Study of Idebenone in Duchenne Muscular Dystrophy (DMD) (DELOS)

  • Buyse GM, Voit T, Schara U, et al. Efficacy of idebenone on respiratory function in patients with Duchenne muscular dystrophy not using glucocorticoids (DELOS): a double-blind randomised placebo-controlled phase 3 trial. Lancet (London, England) 2015;385:1748-1757

Buyse_2015_Lancet. May 2;385(9979);1748-1757

  • McDonald CM, Meier T, Voit T, et al. Idebenone reduces respiratory complications in patients with Duchenne muscular dystrophy. Neuromuscular disorders : NMD 2016;26:473-80

McDonald_2016_Neuromuscul Disord. Aug;26(8);473-80

  • Buyse GM, Voit T, Schara U, et al. Treatment effect of idebenone on inspiratory function in patients with Duchenne muscular dystrophy. Pediatric pulmonology 2017;52:508-515

Buyse_2017_Pediatr Pulmonol. Apr;52(4);508-515

  • Mayer OH, Leinonen M, Rummey C, Meier T, Buyse GM, Group DS. Efficacy of Idebenone to Preserve Respiratory Function above Clinically Meaningful Thresholds for Forced Vital Capacity (FVC) in Patients with Duchenne Muscular Dystrophy. Journal of neuromuscular diseases 2017;4:189-198

Mayer_2017_J Neuromuscul Dis. ;4(3);189-198

  • Meier T, Rummey C, Leinonen M, Spagnolo P, Mayer OH, Buyse GM. Characterization of pulmonary function in 10-18 year old patients with Duchenne muscular dystrophy. Neuromuscular disorders : NMD 2017;27:307-314

Meier_2017_Neuromuscul Disord. Apr;27(4);307-314

 

Phase III placebo controlled study (NCT02814019) and open label extension study (NCT03603288)

A Phase III Double-blind Study With Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Taking Glucocorticoid Steroids (SIDEROS)

Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E)

 

Expanded Access (NCT03433807)

Expanded Access Program for Idebenone in Participants With Duchenne Muscular Dystrophy (DMD)

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