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Trial record 1 of 10 for:    ALKS 3831
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A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02873208
Recruitment Status : Completed
First Posted : August 19, 2016
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Tracking Information
First Submitted Date  ICMJE August 16, 2016
First Posted Date  ICMJE August 19, 2016
Last Update Posted Date October 30, 2019
Actual Study Start Date  ICMJE August 7, 2016
Actual Primary Completion Date October 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2017)
Long-term safety and tolerability of ALKS 3831 assessed by the incidence of adverse events (AEs) [ Time Frame: Up to 56 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2016)
Long-term safety and tolerability of ALKS 3831 assessed by the incidence of treatment emergence adverse events (TEAEs) [ Time Frame: Up to 56 weeks ]
Safety and tolerability will be assessed by the incidence of treatment emergence adverse events (TEAEs)
Change History Complete list of historical versions of study NCT02873208 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia
Official Title  ICMJE A Phase 3, Multicenter Study to Assess the Long Term Safety and Tolerability of ALKS 3831 in Subjects With Schizophrenia
Brief Summary The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 3831 in subjects with schizophrenia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE Drug: ALKS 3831
Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan
Study Arms  ICMJE Experimental: ALKS 3831
Oral tablet, daily dosing
Intervention: Drug: ALKS 3831
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2019)
266
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2016)
540
Actual Study Completion Date  ICMJE October 17, 2019
Actual Primary Completion Date October 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Agrees to use an acceptable method of contraception for the duration of the study
  • Subject has completed the 24-week treatment period in the antecedent study, ALK3831-A303, within 7 days
  • Additional criteria may apply

Exclusion Criteria:

  • Subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine
  • Subject has a positive test for drugs of abuse at study entry
  • Subject is pregnant, planning to become pregnant, or breastfeeding during the study
  • Additional criteria may apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02873208
Other Study ID Numbers  ICMJE ALK3831-A304
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alkermes, Inc.
Study Sponsor  ICMJE Alkermes, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alkermes Medical Director Alkermes, Inc.
PRS Account Alkermes, Inc.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP