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Long-term safety of aripiprazole lauroxil in stable schizophrenia
NCT01895452Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2013
- Primary completion
- Jun 2016
- Countries
- 8
- Sponsor
- Alkermes
- Modality
- Prodrugs/Conditional Activator Small Molecules
- Conditions
- schizophrenia
01
Overview
Phase 3, open-label trial of aripiprazole lauroxil in schizophrenia (2 arms), sponsored by Alkermes. Primary endpoint: Treatment-emergent Adverse Events at 12 months. Started Jul 2013; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
ALKS 9072, Low Dose
Aripiprazole lauroxil low dose monthly injection
ALKS 9072, High Dose
Aripiprazole lauroxil high dose monthly injection
03
Who it enrols
Patients who completed the treatment period of Study ALK9072-003EXT, require chronic antipsychotic treatment, reside in a stable living situation, and have a reliable informant.
04
Endpoints
Primary
Treatment-emergent Adverse Events
Secondary
Positive and Negative Syndrome Scale Total Score
Clinical Global Impression - Severity
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