Status:
COMPLETED
A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia
Lead Sponsor:
Alkermes, Inc.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study will determine the pharmacokinetics (PK), safety, and tolerability of ALKS 9072 (also known as ALKS 9070) after 4 monthly doses in adults with chronic stable schizophrenia.
Detailed Description
Three active treatment groups and a placebo group are planned. Randomization will be sequential by dose level across the sites with placebo assignments randomly inserted. Each subject's participation ...
Eligibility Criteria
Inclusion
- Diagnosis of chronic schizophrenia that is clinically stable
- Body mass index (BMI) between 18.5 and 35.0 kg/m2, inclusive
- Stable antipsychotic medication regimen for \>/= 2 months before Screening
- Be willing and able to be confined to an inpatient clinical research unit for a total of 37 days during the course of the study
Exclusion
- Aripiprazole used within 30 days before Screening
- History of intolerance of or allergy or hypersensitivity to aripiprazole, its excipients, other antipsychotic agents, or INTRALIPID (including peanuts, soy, egg, or glycerol)
- Current diagnosis of an Axis I disorder other than schizophrenia
- History of seizure disorder or any condition associated with seizures
- History of neuroleptic malignant syndrome (NMS)
- Positive test result for HIV, hepatitis B surface antigen, or anti-hepatitis C antibodies
- Received medication by IM injection within 30 days before Screening
- Monoamine oxidase inhibitors (eg, phenelzine, tranylcypromine, selegiline) used within 30 days before Screening
- DSM-IV-TR diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence within 12 months before Screening
- Donation of blood or blood components within 4 weeks before Screening
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT01493726
Start Date
December 1 2011
End Date
June 1 2013
Last Update
August 29 2018
Active Locations (6)
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1
Alkermes Investigational Site
Atlanta, Georgia, United States, 30338
2
Alkermes Investigational Site
Hoffman Estates, Illinois, United States, 60169
3
Alkermes Investigational Site
St Louis, Missouri, United States, 63118
4
Alkermes Investigational Site
Willingboro, New Jersey, United States, 08046