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: 13 Jul 2017

At a glance

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

    • 07 Jul 2017 Status changed from active, no longer recruiting to completed.
    • 29 Jun 2017 Alkermes will present comprehensive data from this trial at an upcoming medical meeting and submit the results for publication in a peer-reviewed journal, according to an Alkermes media release.
    • 29 Jun 2017 Primary endpoint (Change from baseline in Positive and Negative Syndrome Scale (PANSS)) has been met, according to an Alkermes media release.
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