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
- 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.