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Trial record 1 of 1 for:    NCT01626456
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A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

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: NCT01626456
Recruitment Status : Completed
First Posted : June 22, 2012
Results First Posted : October 27, 2016
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Drug: ALKS 9072, Low Drug: ALKS 9072, High Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 478 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (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
Study Start Date : June 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Experimental: ALKS 9072, Low Drug: ALKS 9072, Low
IM injection, given monthly
Experimental: ALKS 9072, High Drug: ALKS 9072, High
IM injection, given monthly


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


Secondary Outcome Measures :
  1. 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.

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

  3. 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.

  4. 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%.

  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).


Eligibility Criteria
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Information from the National Library of Medicine

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

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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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): NCT01626456


Locations
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Sponsors and Collaborators
Alkermes, Inc.
Investigators
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Study Director: Alkermes Medical Director Alkermes, Inc.
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT01626456    
Other Study ID Numbers: ALK9072-003EXT
First Posted: June 22, 2012    Key Record Dates
Results First Posted: October 27, 2016
Last Update Posted: September 25, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders