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Santhera Completes Enrollment of Phase 3 SIDEROS Study With Puldysa® (Idebenone) in Duchenne Muscular Dystrophy (DMD)


Santhera Pharmaceuticals announces full recruitment of its Phase 3 SIDEROS study with idebenone in Duchenne muscular dystrophy (DMD). The sample-size and variability re-assessment performed according to study protocol demonstrated that with the currently enrolled patients the study has a very high power (>99%). Given the strong powering of SIDEROS, the Company is now assessing the potential of conducting an interim analysis to test for overwhelming efficacy with a view of completing the trial early.

With patient recruitment into the 18-month international SIDEROS trial in its final stages, Santhera performed the planned sample size and variability re-assessment in accordance with the study protocol to confirm adequate study power. This blinded analysis showed that variability is lower than anticipated per protocol and, with the current number of enrolled patients, the SIDEROS study has a very high power of over 99% to detect a treatment difference.

Santhera Completes Enrollment Of Phase 3 SIDEROS Study With Puldysa® (Idebenone) In Duchenne Muscular Dystrophy (DMD)