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A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01469039
Recruitment Status : Completed
First Posted : November 10, 2011
Results First Posted : January 22, 2016
Last Update Posted : January 11, 2017
Information provided by (Responsible Party):
Alkermes, Inc.

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: ALKS 9072 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 623 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2011
Primary Completion Date : January 2014
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ALKS 9072 Drug: ALKS 9072
Intramuscular (IM) injection, 441 mg or 882 mg given monthly
Placebo Comparator: Placebo Drug: Placebo
Placebo for IM injection, given monthly

Primary Outcome Measures :
  1. The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: Data collected from baseline to day 85 ]
    The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition.

Secondary Outcome Measures :
  1. Clinical Global Impression - Improvement (CGI-I) Scores at Day 85 [ Time Frame: 85 Days ]
    The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the study. Results indicate participants evaluated at one of the following categories: "1: very much improved"; "2: much improved"; "3: minimally improved"; "4: no change"; "5: minimally worse"; "6: much worse"; or "7: very much worse".

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469039

  Show 84 Study Locations
Sponsors and Collaborators
Alkermes, Inc.
Study Director: Robert Risinger, MD Alkermes, Inc.

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT01469039     History of Changes
Other Study ID Numbers: ALK9072-003
First Posted: November 10, 2011    Key Record Dates
Results First Posted: January 22, 2016
Last Update Posted: January 11, 2017
Last Verified: November 2016

Keywords provided by Alkermes, Inc.:
ALKS 9072
ALKS 9070
aripiprazole lauroxil

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole lauroxil
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs