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Search / Trial NCT02636842

A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder

Launched by ALKERMES, INC. · Dec 21, 2015

Trial Information

Current as of May 28, 2025

Completed

Keywords

Schizophrenia Schizoaffective Disorder Aripiprazole Lauroxil Aripiprazole Alks 9072 Alkermes

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Has a diagnosis of chronic schizophrenia or schizoaffective disorder
  • Has demonstrated ability to tolerate aripiprazole
  • Has been on a stable antipsychotic medication regimen without any changes for at least 2 months prior to screening
  • Has a body mass index (BMI) of 18.0 to 40.0 kg/m2, inclusive
  • Additional criteria may apply
  • Exclusion Criteria:
  • Is pregnant, is planning to become pregnant, or is currently breastfeeding
  • Has received aripiprazole lauroxil or IM depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months or currently treated with clozapine
  • Is a danger to himself/herself at screening or upon admission
  • Has a history of or positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • Has a positive urine drug screen at screening or Day 1
  • Additional criteria may apply

About Alkermes, Inc.

Alkermes, Inc. is a biopharmaceutical company dedicated to developing innovative therapies for the treatment of central nervous system (CNS) and addiction-related disorders. With a focus on addressing unmet medical needs, Alkermes leverages its expertise in drug formulation and delivery to create effective and patient-centric solutions. The company's robust pipeline includes both proprietary and partnered programs aimed at improving the lives of individuals affected by complex and challenging conditions. Committed to scientific excellence and patient safety, Alkermes collaborates with healthcare professionals and stakeholders to advance research and bring transformative treatments to market.

Locations

Cerritos, California, United States

Oakland, California, United States

Hoffman Estates, Illinois, United States

Marlton, New Jersey, United States

Lemon Grove, California, United States

Marlton, New Jersey, United States

Dallas, Texas, United States

Patients applied

0 patients applied

Trial Officials

Robert Risinger, MD

Study Director

Alkermes, Inc.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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