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A Phase 2, Efficacy, Safety and Tolerability Study of ALKS 3831 in Schizophrenia With Alcohol Use Disorder

Trial Profile

A Phase 2, Efficacy, Safety and Tolerability Study of ALKS 3831 in Schizophrenia With Alcohol Use Disorder

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 22 May 2019

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At a glance

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

    • 23 May 2018 According to the Alkermes media release, data from this study will be presented at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting.
    • 09 May 2018 Primary endpoint (Time to first event of exacerbation of disease: ALKS3831 versus OLZ+PBO) has not been met, according to primary outcome details presented at the 171st Annual Meeting of the American Psychiatric Association.
    • 09 May 2018 Results of post hoc analysis assessing symptom outcomes along with primary outcome details, presented at the 171st Annual Meeting of the American Psychiatric Association.
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