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A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

This study has been completed.
Information provided by (Responsible Party):
Alkermes, Inc. Identifier:
First received: June 15, 2012
Last updated: September 8, 2016
Last verified: September 2016
This study will evaluate the safety and durability of effect of ALKS 9072 (also known as ALKS 9070) during long-term treatment of subjects with stable schizophrenia.

Condition Intervention Phase
Drug: ALKS 9072, Low
Drug: ALKS 9072, High
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Extension of Study ALK9072-003 to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia

Resource links provided by NLM:

Further study details as provided by Alkermes, Inc.:

Primary Outcome Measures:
  • Number of Subjects With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: 52 weeks ]
    This measure includes incidences >5%.

Secondary Outcome Measures:
  • Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S) [ Time Frame: 52 weeks ]
    The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients". Results indicate a change in CGI-S score from baseline to Day 365 based on the observed data.

  • Discontinuation From Study Due to Adverse Events (AEs) [ Time Frame: 52 weeks ]
    Number of subjects who discontinued the study due to AE.

  • Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 52 weeks ]
    The C-SSRS is a questionnaire used for suicide assessment. Subjects are asked a series of questions that determine whether or not the patient demonstrates any suicidal ideation or behavior. The C-SSRS was administered to subjects at each study visit.

  • Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests [ Time Frame: 52 weeks ]
    Includes incidence >2% but <5%.

  • Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores [ Time Frame: 52 weeks ]
    This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale), 7 (positive/negative subscales), and 16 (general subscale); maximum scores (worst outcome) equals 210 (total scale), 49 (positive/negative subscales), and 112 (general subscale).

Enrollment: 478
Study Start Date: June 2012
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALKS 9072, Low Drug: ALKS 9072, Low
IM injection, given monthly
Experimental: ALKS 9072, High Drug: ALKS 9072, High
IM injection, given monthly


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

Inclusion Criteria:

(Subjects who participated in ALK9072-003)

  • Completed the ALK9072-003 Day 85 visit
  • Continues to require treatment with an antipsychotic medication

(New Subjects)

  • On a stable dose of oral antipsychotic medication
  • Diagnosis of chronic schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria that is clinically stable
  • Has been able to achieve outpatient status for more than 3 months prior to screening
  • Body Mass Index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
  • Resides in a stable living situation

Exclusion Criteria:

(Subjects who participated in ALK9072-003)

  • Abnormal clinical laboratory, vital sign, or electrocardiogram (ECG) finding during participation in study ALK9072-003 that was clinically relevant and related to study drug
  • Missed more than 1 scheduled study visit during participation in study ALK9072-003
  • Has a significant or unstable medical condition that would preclude safe completion of the current study
  • Subject is pregnant or breastfeeding
  • Subject expects to be incarcerated in the next 12 months, or has pending legal action which may impact compliance with study participation or procedures

(New Subjects)

  • History of poor or inadequate clinical response to treatment with aripiprazole
  • History of treatment resistance
  • Diagnosis of current substance dependence (including alcohol)
  • Pregnant, lactating, or breastfeeding
  • Has received any long-acting intramuscular antipsychotic medication within 60 days prior to screening
  • Currently under involuntary hospitalization
  • Current or expected incarceration

Additional inclusion/exclusion criteria may apply

  Contacts and Locations
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Please refer to this study by its identifier: NCT01626456

  Show 82 Study Locations
Sponsors and Collaborators
Alkermes, Inc.
Study Director: Robert Risinger, MD Alkermes, Inc.
  More Information

Responsible Party: Alkermes, Inc. Identifier: NCT01626456     History of Changes
Other Study ID Numbers: ALK9072-003EXT
Study First Received: June 15, 2012
Results First Received: April 29, 2016
Last Updated: September 8, 2016

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders processed this record on April 28, 2017