A Phase 3 Study to Determine the Antipsychotic Efficacy and Safety of ALKS 3831 in Adult Subjects With Acute Exacerbation of Schizophrenia.

Trial Profile

A Phase 3 Study to Determine the Antipsychotic Efficacy and Safety of ALKS 3831 in Adult Subjects With Acute Exacerbation of Schizophrenia.

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Apr 2018

At a glance

  • Drugs Olanzapine/samidorphan (Primary) ; Olanzapine
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Acronyms ENLIGHTEN-1
  • Sponsors Alkermes plc
  • Most Recent Events

    • 30 Apr 2018 According to an Alkermes media release, data will be presented at the 2018 American Psychiatric Association (APA) Annual Meeting.
    • 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.
    • 07 Jul 2017 Status changed from active, no longer recruiting to completed.
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