Phase 3
N=623
A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01469039 ↗Enrolled (actual)
623
Serious AEs
1.8%
Results posted
Jan 2016
Primary outcome: Primary: The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score — -20.9; -21.8; -9.8 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ALKS 9072 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alkermes, Inc.
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score |
-20.9; -21.8; -9.8 | <0.001 sig |
| SECONDARY Clinical Global Impression - Improvement (CGI-I) Scores at Day 85 |
27; 25; 15; 68; 81; 33 | <0.001 sig |
Summary
The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of schizophrenia according to DSM-IV-TR criteria
- Has been able to achieve outpatient status for more than 3 months in the past year
- Body mass index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
- Resides in a stable living situation
- Willing and able to be confined to an inpatient study unit for 2 weeks or longer
Exclusion Criteria
- History of poor or inadequate clinical response to treatment with aripiprazole
- History of treatment resistance
- Known or suspected intolerance of, allergy, or hypersensitivity to aripiprazole, its ingredients, other antipsychotic agent, or INTRALIPID (including peanuts, soy, egg, or glycerol)
- Diagnosis of current substance dependence (including alcohol)
- Pregnant, lactating, or breastfeeding
- Receipt of any antipsychotic medication by IM injection within 60 days before Screening
- Current involuntary hospitalization or incarceration
- Hospitalized for more than 30 days during the 90 days before Screening
Additional inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01469039). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.