Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study

Next Previous
Trial Profile

A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 06 Dec 2021

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Idebenone (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Adverse reactions; Registrational
  • Acronyms SIDEROS-E
  • Sponsors Santhera Pharmaceuticals

    • Most Recent Events

    • 14 Oct 2020 This trial has been completed in Belgium as per European clinical database record . global end of the trial 2020-10-05
    • 06 Oct 2020 According to a Santhera Pharmaceuticals media release, in connection with this decision, Santhera intends to start a restructuring process, aligning its operations to focus on progressing vamorolone for DMD, lonodelestat for cystic fibrosis and other lung diseases and its discovery-stage gene therapy approach for congenital muscular dystrophy.
    • 06 Oct 2020 According to a Santhera Pharmaceuticals media release, based on the completed interim analysis which tested for efficacy, the DSMB has recommended the SIDEROS study be discontinued due to futility. As a consequence, the company will discontinue the study including extension and withdraw the European marketing authorization application and end the global development program for Puldysa. Participants who are enrolled in the study will discontinue study medication and complete the follow-up.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Legal
Back to top