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Trial record 3 of 10 for:    ALKS 3831

A 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: NCT02669758
Recruitment Status : Completed
First Posted : February 1, 2016
Results First Posted : July 9, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Tracking Information
First Submitted Date  ICMJE January 28, 2016
First Posted Date  ICMJE February 1, 2016
Results First Submitted Date  ICMJE June 18, 2019
Results First Posted Date  ICMJE July 9, 2019
Last Update Posted Date July 26, 2019
Actual Study Start Date  ICMJE January 20, 2016
Actual Primary Completion Date June 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 52 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 28, 2016)
Incidence of Adverse Events [ Time Frame: 56 weeks ]
Change History
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 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
Tablets were administered for daily dosing
Study Arms  ICMJE Experimental: ALKS 3831
Olanzapine + samidorphan; administered as a coated bilayer tablet.
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: July 26, 2018)
281
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2016)
390
Actual Study Completion Date  ICMJE June 29, 2018
Actual Primary Completion Date June 29, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject has completed the 4-week treatment period (all visits up to and including end of treatment visit) in the antecedent study ALK3831-A305 within 7 days.
  • Agrees to use an acceptable method of contraception for the duration of the study.
  • Additional criteria may apply.

Exclusion Criteria:

  • Subject is currently taking medications that are contraindicated with olanzapine use.
  • 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 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Serbia,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02669758
Other Study ID Numbers  ICMJE ALK3831-A306
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alkermes, Inc.
Study Sponsor  ICMJE Alkermes, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Alkermes Medical Director Alkermes, Inc.
PRS Account Alkermes, Inc.
Verification Date July 2019

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