A Phase 3 Study to Determine the Antipsychotic Efficacy and Safety of ALKS 3831 in Adult Subjects With Acute Exacerbation of Schizophrenia.
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History