A Study to Evaluate the Efficacy and Safety of ALKS 9072 in Subjects With Schizophrenia

This study is currently recruiting participants.

Verified January 2013 by Alkermes

Sponsor:

Information provided by (Responsible Party):

Alkermes

ClinicalTrials.gov Identifier:

NCT01469039

First received: November 8, 2011

Last updated: January 29, 2013

Last verified: January 2013

History of Changes

Purpose

The study will determine the efficacy of ALKS 9072 (also known as ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.

Condition	Intervention	Phase
Schizophrenia	Drug: ALKS 9072 Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of ALKS 9072 in Subjects With Acute Exacerbation of Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Further study details as provided by Alkermes:

Primary Outcome Measures:

Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: 85 Days ] [ Designated as safety issue: No ]
Change from baseline to Day 85

Secondary Outcome Measures:

Clinical Global Impression - Improvement (CGI-I) Scores [ Time Frame: 85 Days ] [ Designated as safety issue: No ]

Estimated Enrollment:	690
Study Start Date:	December 2011
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ALKS 9072	Drug: ALKS 9072 Intramuscular (IM) injection, 300mg or 600mg given monthly
Placebo Comparator: Placebo	Drug: Placebo Placebo for IM injection, given monthly

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of schizophrenia according to DSM-IV-TR criteria
Has been able to achieve outpatient status for more than 3 months in the past year
Body mass index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
Resides in a stable living situation
Willing and able to be confined to an inpatient study unit for 2 weeks or longer

Exclusion Criteria:

History of poor or inadequate clinical response to treatment with aripiprazole
History of treatment resistance
Known or suspected intolerance of, allergy, or hypersensitivity to aripiprazole, its ingredients, other antipsychotic agent, or INTRALIPID (including peanuts, soy, egg, or glycerol)
Diagnosis of current substance dependence (including alcohol)
Pregnant, lactating, or breastfeeding
Receipt of any antipsychotic medication by IM injection within 60 days before Screening
Current involuntary hospitalization or incarceration
Hospitalized for more than 30 days during the 90 days before Screening

Additional inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01469039

Contacts

Contact: Chris Southard

919-418-4823

Show 71 Study Locations

Sponsors and Collaborators

Alkermes

Investigators

Study Director:

Robert Risinger, MD

Alkermes

More Information

No publications provided

Responsible Party:	Alkermes
ClinicalTrials.gov Identifier:	NCT01469039 History of Changes
Other Study ID Numbers:	ALK9072-003
Study First Received:	November 8, 2011
Last Updated:	January 29, 2013
Health Authority:	United States: Food and Drug Administration Bulgaria: Bulgarian Drug Agency Malaysia: Ministry of Health Philippines: Department of Health Romania: National Medicines Agency Russia: Ministry of Health of the Russian Federation Serbia and Montenegro: Agency for Drugs and Medicinal Devices Ukraine: Ministry of Health

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013

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