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A Study of ALKS 3831 in Adults With Schizophrenia

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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.

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Samidorphan (Low Dose) Drug: Samidorphan (Medium Dose) Drug: Samidorphan (High Dose) Drug: Placebo Drug: Olanzapine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 309 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Olanzapine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Low Dose
Olanzapine + low dose samidorphan tablets taken once daily
Drug: Samidorphan (Low Dose)
Tablets taken once daily
Other Name: Low dose samidorphan (ALKS 33)
Drug: Olanzapine
Tablets taken once daily
Experimental: Medium Dose
Olanzapine + medium dose samidorphan tablets taken once daily
Drug: Samidorphan (Medium Dose)
Tablets taken once daily
Other Name: Medium dose samidorphan (ALKS 33)
Drug: Olanzapine
Tablets taken once daily
Experimental: High Dose
Olanzapine + high dose samidorphan tablets taken once daily
Drug: Samidorphan (High Dose)
Tablets taken once daily
Other Name: High dose samidorphan (ALKS 33)
Drug: Olanzapine
Tablets taken once daily
Placebo Comparator: Placebo
Olanzapine + placebo tablets taken once daily
Drug: Placebo
Tablets taken once daily
Drug: Olanzapine
Tablets taken once daily



Primary Outcome Measures :
  1. Change in Positive and Negative Syndrome Scale (PANSS) score [ Time Frame: 12 weeks ]
    Change from baseline


Secondary Outcome Measures :
  1. Percent change in body weight from baseline to the end of Part A [ Time Frame: 12 weeks ]
  2. 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).

  3. Change in body weight [ Time Frame: 12 weeks ]
  4. Proportion of subjects exhibiting significant weight gain [ Time Frame: 12 weeks ]
    Significant weight gain will include body weight gain greater than 7%

  5. Change in Clinical Global Impressions - Severity (CGI-S) [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903837


  Show 61 Study Locations
Sponsors and Collaborators
Alkermes, Inc.
Investigators
Study Director: Bernard L. Silverman, MD Alkermes, Inc.

Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT01903837     History of Changes
Other Study ID Numbers: ALK3831-302
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: April 2015

Keywords provided by Alkermes, Inc.:
Schizophrenia
Olanzapine
Samidorphan
Alkermes

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Olanzapine
Naltrexone
ALKS-33
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Narcotic Antagonists
Sensory System Agents