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: 30 Jul 2018

At a glance

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

    • 30 Jul 2018 Chile, Grece, Mexico and South Africa were the planned locations for this study.
    • 30 Jul 2018 According to a Merck KGaA 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 US FDA has accepted the New Drug Application (NDA) for cladribine tablets, after the resubmission of an application, as a potential treatment for patients with relapsing forms of multiple sclerosis (MS).
    • 19 Jun 2018 Results of a post-hoc analysis from CLARITY, CLARITY-Extension, ORACLE-MS and PREMIERE, trials presented at the 4th Congress of the European Academy of Neurology
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