Trial Profile
A Phase II Open-label Extension Study to Obtain Long-term Safety, Tolerability and Efficacy Data of Idebenone in the Treatment of Duchenne Muscular Dystrophy - Extension to Study SNT-II-001
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 28 Sep 2022
Price :
$35
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At a glance
- Drugs Idebenone (Primary)
- Indications Duchenne muscular dystrophy
- Focus Adverse reactions
- Acronyms DELPHI Extension
- Sponsors Santhera Pharmaceuticals
- 29 May 2020 According to a Santhera Pharmaceuticals media release, the company will host a conference call today to discuss this update.
- 29 May 2020 According to a Santhera Pharmaceuticals media release, the CHMP opinion is expected in Q4 2020.
- 29 May 2020 According to a Santhera Pharmaceuticals media release, the company EMA's CHMP has granted a requested extension of the clock-stop in the regulatory procedure for its conditional marketing authorization (CMA) application for Puldysa (idebenone) in Duchenne muscular dystrophy (DMD) to evaluate the potential of conducting an interim analysis to test overwhelming efficacy of its SIDEROS study with a view of including the data in the review procedure and potentially complete the SIDEROS trial early.