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Trial record 1 of 1 for:    NCT01895452
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An Extension of 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: NCT01895452
Recruitment Status : Completed
First Posted : July 10, 2013
Results First Posted : August 25, 2017
Last Update Posted : August 25, 2017
Information provided by (Responsible Party):
Alkermes, Inc.

Brief Summary:
This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue treatment.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: ALKS 9072, Low Dose Drug: ALKS 9072, High Dose Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 291 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter Extension of Study ALK9072-003EXT to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia
Study Start Date : July 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: ALKS 9072, Low Dose Drug: ALKS 9072, Low Dose
Intramuscular injection, given monthly

Experimental: ALKS 9072, High Dose Drug: ALKS 9072, High Dose
Intramuscular injection, given monthly

Primary Outcome Measures :
  1. Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 12 months ]
    This measure includes all incidences, including those that occurred >5%.

Secondary Outcome Measures :
  1. Change in Baseline of Positive and Negative Syndrome Scale (PANSS) Total Score Over Time [ Time Frame: Up to 12 months ]
    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); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and the subject's last visit in the treatment period.

  2. Mean Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Over Time [ Time Frame: Up to 12 months ]
    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. Change is calculated between the baseline visit and the subject's last visit in the treatment period.

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

Inclusion Criteria:

  • Completed the treatment period of Study ALK9072-003EXT
  • Continues to require chronic treatment with an antipsychotic medication
  • Continues to reside in a stable living situation
  • Continues to have an identified reliable informant

Exclusion Criteria:

  • Abnormal clinical laboratory value, vital sign, or electrocardiogram (ECG) finding during participation in Study ALK9072-003EXT that was clinically relevant and related to study drug
  • Missed more than 1 scheduled study visit during participation in the preceding Study ALK9072-003EXT
  • 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, or has pending legal action which may impact compliance with study participation or procedures

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): NCT01895452

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Sponsors and Collaborators
Alkermes, Inc.
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Study Director: Robert Risinger, MD Alkermes, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT01895452    
Other Study ID Numbers: ALK9072-003EXT2
First Posted: July 10, 2013    Key Record Dates
Results First Posted: August 25, 2017
Last Update Posted: August 25, 2017
Last Verified: July 2017
Keywords provided by Alkermes, Inc.:
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders