A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
Status: | Completed |
---|---|
Conditions: | Schizophrenia |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 9/27/2018 |
Start Date: | June 2012 |
End Date: | April 2015 |
A Phase 3, Multicenter, Extension of Study ALK9072-003 to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia
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.
9070) during long-term treatment of subjects with stable schizophrenia.
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
We found this trial at
27
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials