A Phase 3 Study to Evaluate Weight Gain of ALKS 3831 Compared to Olanzapine in Adults With Schizophrenia

Trial Profile

A Phase 3 Study to Evaluate Weight Gain of ALKS 3831 Compared to Olanzapine in Adults With Schizophrenia

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 29 Jul 2018

At a glance

  • Drugs Olanzapine/samidorphan (Primary) ; Olanzapine
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Acronyms ENLIGHTEN-2
  • Sponsors Alkermes plc
  • Most Recent Events

    • 09 May 2018 Planned End Date changed from 1 Sep 2018 to 1 Nov 2018.
    • 09 May 2018 Planned primary completion date changed from 1 Aug 2018 to 1 Nov 2018.
    • 26 Apr 2018 According to an Alkermes media release, data from ENLIGHTEN-1 and ENLIGHTEN-2 will form the basis of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ALKS 3831 for the treatment of schizophrenia.
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