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

This study is currently recruiting participants.
Verified August 2013 by Alkermes
Sponsor:
Information provided by (Responsible Party):
Alkermes
ClinicalTrials.gov Identifier:
NCT01626456
First received: June 15, 2012
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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
Schizophrenia
Drug: ALKS 9072, Low
Drug: ALKS 9072, High
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Primary Outcome Measures:
  • Number and percentage of subjects with treatment-emergent adverse events (TEAEs) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change from baseline to endpoint in Clinical Global Impression Scale for Severity (CGI-S) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Discontinuation from study due to Adverse Events (AEs) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Suicidality will be summarized by change from baseline in the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Incidence of clinically significant changes will be calculated for movement disorders, vital signs and routine laboratory tests [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Positive and Negative Syndrome Scale (PANSS) total score and subscale scores [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Total defined as sum of positive, negative, and general psychopathology subscale scores; subscale defined as positive, negative, general psychopathology scores


Estimated Enrollment: 500
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626456

Contacts
Contact: Chris Southard 919-418-4823

  Show 83 Study Locations
Sponsors and Collaborators
Alkermes
Investigators
Study Director: Robert Risinger, MD Alkermes
  More Information

No publications provided

Responsible Party: Alkermes
ClinicalTrials.gov Identifier: NCT01626456     History of Changes
Other Study ID Numbers: ALK9072-003EXT
Study First Received: June 15, 2012
Last Updated: August 9, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014