A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
Status and phase
Completed
Phase 3
Conditions
Schizophrenia
Treatments
Drug: ALKS 9072, Low
Drug: ALKS 9072, High
Details and patient eligibility
About
This study will evaluate the safety and durability of effect of ALKS 9072 (also known as ALKS 9070) during long-term treatment of subjects with stable schizophrenia.
Enrollment
478 patients
Sex
All
Ages
18 to 70 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
(Subjects who participated in ALK9072-003)
- Completed the ALK9072-003 Day 85 visit
- Continues to require treatment with an antipsychotic medication
(New Subjects)
- On a stable dose of oral antipsychotic medication
- Diagnosis of chronic schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria that is clinically stable
- Has been able to achieve outpatient status for more than 3 months prior to screening
- Body Mass Index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
- Resides in a stable living situation
Exclusion criteria
(Subjects who participated in ALK9072-003)
- Abnormal clinical laboratory, vital sign, or electrocardiogram (ECG) finding during participation in study ALK9072-003 that was clinically relevant and related to study drug
- Missed more than 1 scheduled study visit during participation in study ALK9072-003
- Has a significant or unstable medical condition that would preclude safe completion of the current study
- Subject is pregnant or breastfeeding
- Subject expects to be incarcerated in the next 12 months, or has pending legal action which may impact compliance with study participation or procedures
(New Subjects)
- History of poor or inadequate clinical response to treatment with aripiprazole
- History of treatment resistance
- Diagnosis of current substance dependence (including alcohol)
- Pregnant, lactating, or breastfeeding
- Has received any long-acting intramuscular antipsychotic medication within 60 days prior to screening
- Currently under involuntary hospitalization
- Current or expected incarceration
Additional inclusion/exclusion criteria may apply
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Single Group Assignment
Masking
Quadruple Blind
478 participants in 2 patient groups
ALKS 9072, Low
Experimental group
Treatment:
Drug: ALKS 9072, Low
ALKS 9072, High
Experimental group
Treatment:
Drug: ALKS 9072, High
Trial contacts and locations
82
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Data sourced from clinicaltrials.gov
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