ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01469039
Recruitment Status : Completed
First Posted : November 10, 2011
Results First Posted : January 22, 2016
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

November 8, 2011
November 10, 2011
November 4, 2015
January 22, 2016
January 11, 2017
December 2011
January 2014   (Final data collection date for primary outcome measure)
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.
Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: 85 Days ]
Change from baseline to Day 85
Complete list of historical versions of study NCT01469039 on ClinicalTrials.gov Archive Site
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".
  • Clinical Global Impression - Improvement (CGI-I) Scores [ Time Frame: 85 Days ]
  • PANSS positive subscale - Day 8 [ Time Frame: 8 days ]
    Change from baseline to study Day 8
  • PANSS positive subscale change - Day 15 [ Time Frame: 15 days ]
    Change from baseline to study Day 15
  • PANSS positive subscale - Day 22 [ Time Frame: 22 days ]
    Change from baseline to study Day 22
  • PANSS positive subscale - Day 29 [ Time Frame: 29 days ]
    Change from baseline to study Day 29
  • PANSS positive subscale - Day 57 [ Time Frame: 57 days ]
    Change from baseline to study Day 57
  • PANSS positive subscale - Day 85 [ Time Frame: 85 days ]
    Change from baseline to study Day 85
  • PANSS total score - Day 8 [ Time Frame: 8 days ]
    Total score change from baseline to study Day 8
  • PANSS total score - Day 15 [ Time Frame: 15 days ]
    Total score change from baseline to study Day 15
  • PANSS total score - Day 22 [ Time Frame: 22 days ]
    Total score change from baseline to study Day 22
  • PANSS total score - Day 29 [ Time Frame: 29 days ]
    Total score change from baseline to study Day 29
  • PANSS total score - Day 57 [ Time Frame: 57 days ]
    Total score change from baseline to study Day 57
  • PANSS response - Day 8 [ Time Frame: 8 days ]
    Total score >/=30% decrease from baseline to study Day 8
  • PANSS response - Day 15 [ Time Frame: 15 days ]
    Total score >/= 30% decrease from baseline to study Day 15
  • PANSS response - Day 22 [ Time Frame: 22 days ]
    Total score >/= 30% decrease from baseline to study Day 22
  • PANSS response - Day 29 [ Time Frame: 29 days ]
    Total score >/= 30% decrease from baseline to study Day 29
  • PANSS response - Day 57 [ Time Frame: 57 days ]
    Total score >/= 30% decrease from baseline to study Day 57
  • PANSS response - Day 85 [ Time Frame: 85 days ]
    Total score >/= 30% decrease from baseline to study Day 85
  • Overall response - Day 8 [ Time Frame: 8 days ]
    PANSS response or CGI-I score of 2 or 1 at study Day 8
  • Overall response - Day 15 [ Time Frame: 15 days ]
    PANSS response or CGI-I score of 2 or 1 at study Day 15
  • Overall response - Day 22 [ Time Frame: 22 days ]
    PANSS response or CGI-I score of 2 or 1 at study Day 22
  • Overall response - Day 29 [ Time Frame: 29 days ]
    PANSS response or CGI-I score of 2 or 1 at study Day 29
  • Overall response - Day 57 [ Time Frame: 57 days ]
    PANSS response or CGI-I score of 2 or 1 at study Day 57
  • Overall response - Day 85 [ Time Frame: 85 days ]
    PANSS response or CGI-I score of 2 or 1 at study Day 85
  • PANSS negative subscale - Day 8 [ Time Frame: 8 days ]
    Change from baseline to study Day 8
  • PANSS negative subscale - Day 15 [ Time Frame: 15 days ]
    Change from baseline to study Day 15
  • PANSS negative subscale - Day 22 [ Time Frame: 22 days ]
    Change from baseline to study Day 22
  • PANSS negative subscale - Day 29 [ Time Frame: 29 days ]
    Change from baseline to study Day 29
  • PANSS negative subscale - Day 57 [ Time Frame: 57 days ]
    Change from baseline to study Day 57
  • PANSS negative subscale - Day 85 [ Time Frame: 85days ]
    Change from baseline to study Day 85
  • PANSS general psychopathology subscale - Day 8 [ Time Frame: 8 days ]
    Change from baseline to study Day 8
  • PANSS general psychopathology subscale - Day 15 [ Time Frame: 15 days ]
    Change from baseline to study Day 15
  • PANSS general psychopathology subscale - Day 22 [ Time Frame: 22 days ]
    Change from baseline to study Day 22
  • PANSS general psychopathology subscale - Day 29 [ Time Frame: 29 days ]
    Change from baseline to study Day 29
  • PANSS general psychopathology subscale - Day 57 [ Time Frame: 57 days ]
    Change from baseline to study Day 57
  • PANSS general psychopathology subscale - Day 85 [ Time Frame: 85 days ]
    Change from baseline to study Day 85
  • Clinical Global Impression - Severity (CGI-S) score change - Day 8 [ Time Frame: 8 days ]
    Change from baseline to study Day 8
  • CGI-S score change - Day 15 [ Time Frame: 15 days ]
    Change from baseline to study Day 15
  • CGI-S score change - Day 22 [ Time Frame: 22 days ]
    Change from baseline to study Day 22
  • CGI-S score change - Day 29 [ Time Frame: 29 days ]
    Change from baseline to study Day 29
  • CGI-S score change - Day 57 [ Time Frame: 57 days ]
    Change from baseline to study Day 57
  • CGI-S score change - Day 85 [ Time Frame: 85 days ]
    Change from baseline to study Day 85
  • CGI-I score - Day 8 [ Time Frame: 8 days ]
  • CGI-I score - Day 15 [ Time Frame: 15 days ]
  • CGI-I score - Day 22 [ Time Frame: 22 days ]
  • CGI-I score - Day 29 [ Time Frame: 29 days ]
  • CGI-I score - Day 57 [ Time Frame: 57 days ]
  • Personal and Social Performance scale (PSP) score change - Day 29 [ Time Frame: 29 days ]
    Change from baseline to study Day 29
  • PSP score change - Day 57 [ Time Frame: 57 days ]
    Change from baseline to study Day 57
  • PSP score change - Day 85 [ Time Frame: 85 days ]
    Change from baseline to study Day 85
  • Relapse rate [ Time Frame: 85 days ]
Not Provided
Not Provided
 
A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: ALKS 9072
    Intramuscular (IM) injection, 441 mg or 882 mg given monthly
  • Drug: Placebo
    Placebo for IM injection, given monthly
  • Experimental: ALKS 9072
    Intervention: Drug: ALKS 9072
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
623
540
March 2014
January 2014   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Korea, Republic of,   Malaysia,   Philippines,   Romania,   Russian Federation,   Ukraine,   United States
Serbia
 
NCT01469039
ALK9072-003
Yes
Not Provided
Not Provided
Alkermes, Inc.
Alkermes, Inc.
Not Provided
Study Director: Robert Risinger, MD Alkermes, Inc.
Alkermes, Inc.
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP