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Clinical Trials/NCT01626456
NCT01626456CompletedPhase 3

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

Alkermes, Inc.1 site in 1 country478 target enrollmentStarted: June 2012Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
478
Locations
1
Primary Endpoint
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

ALKS 9072, Low

Experimental

Intervention: ALKS 9072, Low (Drug)

ALKS 9072, High

Experimental

Intervention: ALKS 9072, High (Drug)

Outcomes

Primary Outcomes

Number of Subjects With Treatment-emergent Adverse Events (TEAEs)

Time Frame: 52 weeks

This measure includes incidences \>5%.

Secondary Outcomes

  • Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests(52 weeks)
  • Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores(52 weeks)
  • Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)(52 weeks)
  • Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S)(52 weeks)
  • Discontinuation From Study Due to Adverse Events (AEs)(52 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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