A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ALKS 9072, Low dose

Group Type EXPERIMENTAL

ALKS 9072, Low dose

Intervention Type DRUG

IM injection, given monthly

ALKS 9072, Med dose

Group Type EXPERIMENTAL

ALKS 9072, Med dose

Intervention Type DRUG

IM injection, given monthly

ALKS 9072, High dose

Group Type EXPERIMENTAL

ALKS 9072, High dose

Intervention Type DRUG

IM injection, given monthly

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dosed matched placebo IM injection, given monthly

Interventions

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ALKS 9072, Low dose

IM injection, given monthly

Intervention Type DRUG

ALKS 9072, Med dose

IM injection, given monthly

Intervention Type DRUG

ALKS 9072, High dose

IM injection, given monthly

Intervention Type DRUG

Placebo

Dosed matched placebo IM injection, given monthly

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No