A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia

Alkermes

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: ALKS 9072, Low dose; Drug: ALKS 9072, High dose; Drug: ALKS 9072, Med dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01493726

ALK9072-002

Details and patient eligibility

About

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.

Full 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 will be approximately 8 months, including screening, treatment period, and a 3-month follow-up period.

Enrollment: 88 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 4 patient groups, including a placebo group

ALKS 9072, Low dose

Experimental group

Treatment:

Drug: ALKS 9072, Low dose

ALKS 9072, Med dose

Experimental group

Treatment:

Drug: ALKS 9072, Med dose

ALKS 9072, High dose

Experimental group

Treatment:

Drug: ALKS 9072, High dose

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo