This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Alkermes, Inc. Identifier:
First received: July 5, 2013
Last updated: July 13, 2016
Last verified: July 2016
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: Single Group 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: 12 months ]

Secondary Outcome Measures:
  • Change in baseline of Positive and Negative Syndrome Scale (PANSS) total score over time [ Time Frame: 12 months ]
  • Mean change from baseline to endpoint in Clinical Global Impression - Severity (CGI-S) over time [ Time Frame: 12 months ]

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


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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 identifier: NCT01895452

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

Responsible Party: Alkermes, Inc. Identifier: NCT01895452     History of Changes
Other Study ID Numbers: ALK9072-003EXT2
Study First Received: July 5, 2013
Last Updated: July 13, 2016

Keywords provided by Alkermes, Inc.:

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders processed this record on August 18, 2017