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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014