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An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01895452
First Posted: July 10, 2013
Last Update Posted: August 25, 2017
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.
Information provided by (Responsible Party):
Alkermes, Inc.
  Purpose
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 Intervention Phase
Schizophrenia Drug: ALKS 9072, Low Dose Drug: ALKS 9072, High Dose Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Alkermes, Inc.:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.


Enrollment: 291
Study Start Date: July 2013
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Criteria

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
  Contacts and Locations
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


  Show 57 Study Locations
Sponsors and Collaborators
Alkermes, Inc.
Investigators
Study Director: Robert Risinger, MD Alkermes, Inc.
  More Information

Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT01895452     History of Changes
Other Study ID Numbers: ALK9072-003EXT2
First Submitted: July 5, 2013
First Posted: July 10, 2013
Results First Submitted: June 22, 2017
Results First Posted: August 25, 2017
Last Update Posted: August 25, 2017
Last Verified: July 2017

Keywords provided by Alkermes, Inc.:
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders