A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Oral Cladribine in Subjects With a First Clinical Event at High Risk of Converting to MS.

Trial Profile

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Oral Cladribine in Subjects With a First Clinical Event at High Risk of Converting to MS.

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Oct 2017

At a glance

  • Drugs Cladribine (Primary)
  • Indications Multiple sclerosis
  • Focus Therapeutic Use
  • Acronyms ORACLE-MS
  • Sponsors EMD Serono
  • Most Recent Events

    • 25 Aug 2017 According to a Merck & Co media release, based on the data from three Phase III trials (CLARITY, CLARITY EXTENSION and ORACLE MS) and a phase II trial (ONWARD) including long term data from PREMIERE study, the European Commission (EC) has granted marketing authorization for MAVENCLAD 10mg (Cladribine Tablets) for the treatment of highly active relapsing multiple sclerosis (RMS) in the 28 countries of the European Union (EU).
    • 09 Aug 2017 This study has been discontinued in belgium as per European Clinical Trials Database.
    • 27 Jun 2017 Results of an integrated analysis from three studies (ORACLE-MS, CLARITY, and CLARITY Extension) presented at the 3rd Congress of the European Academy of Neurology
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