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Randomized, double-blind, placebo-controlled, 3-arm, 36 weeks parallel-group study to evaluate the safety and tolerability of ORY-2001 in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS)

Trial Profile

Randomized, double-blind, placebo-controlled, 3-arm, 36 weeks parallel-group study to evaluate the safety and tolerability of ORY-2001 in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS)

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 26 Sep 2019

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At a glance

  • Drugs Vafidemstat (Primary)
  • Indications Multiple sclerosis
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms SATEEN
  • Sponsors Oryzon
  • Most Recent Events

    • 26 Sep 2019 According to an Oryzon media release, duration of open label extension phase has been extended from 6 months to 18 months to allow to assess the effect of vafidemstat as a therapeutic treatment for the progressive form of the disease which requires longerclinical observation periods. This protocol amendment has been approved by the Spanish Medicines Agency.
    • 09 Apr 2018 According to an Oryzon media release, the first patient was enrolled in January 2018.
    • 29 Jan 2018 According to an Oryzon media release, data will be presented at the third annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2018
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