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A 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: NCT01903837
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Tracking Information
First Submitted Date  ICMJE July 5, 2013
First Posted Date  ICMJE July 19, 2013
Last Update Posted Date April 29, 2015
Study Start Date  ICMJE June 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2014)
Change in Positive and Negative Syndrome Scale (PANSS) score [ Time Frame: 12 weeks ]
Change from baseline
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2013)
Safety and tolerability of samidorphan (ALKS 33) [ Time Frame: 12 weeks ]
Safety and tolerability will be assessed by reviewing the rate of adverse events (AEs).
Change History Complete list of historical versions of study NCT01903837 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2014)
  • Percent change in body weight from baseline to the end of Part A [ Time Frame: 12 weeks ]
  • Safety and tolerability of samidorphan (ALKS 33) [ Time Frame: 29 weeks ]
    Safety and tolerability will be assessed by number and percentage of subjects with adverse events (AEs).
  • Change in body weight [ Time Frame: 12 weeks ]
  • Proportion of subjects exhibiting significant weight gain [ Time Frame: 12 weeks ]
    Significant weight gain will include body weight gain greater than 7%
  • Change in Clinical Global Impressions - Severity (CGI-S) [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2013)
  • Percent change in body weight from baseline to the end of Part A [ Time Frame: 12 weeks ]
  • Absolute change in Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 12 weeks ]
  • Absolute change in body weight [ Time Frame: 12 weeks ]
  • Proportion of subjects exhibiting significant weight gain [ Time Frame: 12 weeks ]
    Significant weight gain will include body weight gain greater than 7%
  • Absolute change in Clinical Global Impressions - Severity (CGI-S) [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of ALKS 3831 in Adults With Schizophrenia
Official Title  ICMJE A Phase 2, Randomized, Multicenter, Safety, Tolerability, and Dose-Ranging Study of Samidorphan, a Component of ALKS 3831, in Adults With Schizophrenia Treated With Olanzapine
Brief Summary This is a Phase 2, randomized, placebo-controlled multicenter study, which will be conducted in 2 parts. The study duration for each subject will be approximately 33 weeks and will include 25 study visits.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Samidorphan (Low Dose)
    Tablets taken once daily
    Other Name: Low dose samidorphan (ALKS 33)
  • Drug: Samidorphan (Medium Dose)
    Tablets taken once daily
    Other Name: Medium dose samidorphan (ALKS 33)
  • Drug: Samidorphan (High Dose)
    Tablets taken once daily
    Other Name: High dose samidorphan (ALKS 33)
  • Drug: Placebo
    Tablets taken once daily
  • Drug: Olanzapine
    Tablets taken once daily
Study Arms  ICMJE
  • Experimental: Low Dose
    Olanzapine + low dose samidorphan tablets taken once daily
    Interventions:
    • Drug: Samidorphan (Low Dose)
    • Drug: Olanzapine
  • Experimental: Medium Dose
    Olanzapine + medium dose samidorphan tablets taken once daily
    Interventions:
    • Drug: Samidorphan (Medium Dose)
    • Drug: Olanzapine
  • Experimental: High Dose
    Olanzapine + high dose samidorphan tablets taken once daily
    Interventions:
    • Drug: Samidorphan (High Dose)
    • Drug: Olanzapine
  • Placebo Comparator: Placebo
    Olanzapine + placebo tablets taken once daily
    Interventions:
    • Drug: Placebo
    • Drug: Olanzapine
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: April 7, 2015)
309
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2013)
400
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 to 50 years, inclusive
  • Body mass index (BMI) of 17-30 kg/m2, inclusive
  • Diagnosis of schizophrenia that is clinically stable

Exclusion Criteria:

  • Initiated 1st antipsychotic treatment within the past 12 months and/or has had symptoms lasting <2 years
  • Current diagnosis of alcohol or drug use disorder, moderate or severe
  • Clinically significant or unstable medical illness, condition, or disorder
  • Pregnant or breastfeeding
  • Significant changes in diet or exercise regimen or plans to join a weight management program during the study
  • Opioid medications taken within 14 days and/or need to take opioid medication during the study period
  • History of hypersensitivity to or intolerance of olanzapine
  • Use of olanzapine, clozapine, mesoridazine, chlorpromazine, or thioridazine for more than 1 week during the past year
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Czech Republic,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01903837
Other Study ID Numbers  ICMJE ALK3831-302
Has Data Monitoring Committee Yes
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: Bernard L. Silverman, MD Alkermes, Inc.
PRS Account Alkermes, Inc.
Verification Date April 2015

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