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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

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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

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


  Hide Study Locations
Locations
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United States, Arkansas
Alkermes Investigational Site
Little Rock, Arkansas, United States, 72211
United States, California
Alkermes Investigational Site
Anaheim, California, United States, 92805
Alkermes Investigational Site
Costa Mesa, California, United States, 92626
Alkermes Investigational Site
Culver City, California, United States, 90230
Alkermes Investigational Site
Escondito, California, United States, 92025
Alkermes Investigational Site
Garden Grove, California, United States, 92845
Alkermes Investigational Site
National City, California, United States, 91950
Alkermes Investigational Site
Oakland, California, United States, 94612
Alkermes Investigational Site
Oceanside, California, United States, 92056
Alkermes Investigational Site
Orange, California, United States, 92868
Alkermes Investigational Site
Pico Rivera, California, United States, 90660
Alkermes Investigational Site
San Diego, California, United States, 92103
Alkermes Investigational Site
Torrance, California, United States, 90502
United States, Connecticut
Alkermes Investigational Site
New Britain, Connecticut, United States, 06052
United States, District of Columbia
Alkermes Investigational Site
Washington, District of Columbia, United States, 20016
United States, Florida
Alkermes Investigational Site
Bradenton, Florida, United States, 34208
Alkermes Investigational Site
Ft. Lauderdale, Florida, United States, 33308
Alkermes Investigational Site
Gainesville, Florida, United States, 32607
Alkermes Investigational Site
Kissimmee, Florida, United States, 34741
Alkermes Investigational Site
Leesburg, Florida, United States, 34748
Alkermes Investigational Site
Oakland Park, Florida, United States, 33334
Alkermes Investigational Site
Orlando, Florida, United States, 32810
United States, Georgia
Alkermes Investigational Site
Atlanta, Georgia, United States, 30308
Alkermes Investigational Site
Decatur, Georgia, United States, 30030
United States, Illinois
Alkermes Investigational Site
Chicago, Illinois, United States, 60640
United States, Louisiana
Alkermes Investigational Site
Lake Charles, Louisiana, United States, 70629
Alkermes Investigational Site
Shreveport, Louisiana, United States, 71101
United States, Maryland
Alkermes Investigational Site
Rockville, Maryland, United States, 20850
United States, Mississippi
Alkermes Investigational Site
Flowood, Mississippi, United States, 39232
United States, Missouri
Alkermes Investigational Site
Creve Couer, Missouri, United States, 63141
Alkermes Investigational Site
St. Louis, Missouri, United States, 63118
United States, New Jersey
Alkermes Investigational Site
Marlton, New Jersey, United States, 08053
Alkermes Investigational Site
Neptune, New Jersey, United States, 07754
United States, Ohio
Alkermes Investigational Site
Canton, Ohio, United States, 44718
Alkermes Investigational Site
Mason, Ohio, United States, 45040
United States, Oklahoma
Alkermes Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Alkermes Investigational Site
Oklahoma City, Oklahoma, United States, 73116
United States, Pennsylvania
Alkermes Investigational Site
Philadelphia, Pennsylvania, United States, 19139
United States, South Carolina
Alkermes Investigational Site
Charleston, South Carolina, United States, 29407
United States, Tennessee
Alkermes Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Alkermes Investigational Site
Austin, Texas, United States, 78731
Alkermes Investigational Site
Austin, Texas, United States, 78754
Alkermes Investigational Site
Dallas, Texas, United States, 75231
Alkermes Investigational Site
Dallas, Texas, United States, 75243
Alkermes Investigational Site
Desoto, Texas, United States, 75115
Alkermes Investigational Site
Houston, Texas, United States, 77007
Alkermes Investigational Site
Houston, Texas, United States, 77008
United States, Utah
Alkermes Investigational Site
Salt Lake City, Utah, United States, 84106
United States, Washington
Alkermes Investigational Site
Bellvue, Washington, United States, 98007
Alkermes Investigational Site
Richland, Washington, United States, 99362
Bulgaria
Alkermes Investigational Site
Burgas, Bulgaria, 8000
Alkermes Investigational Site
Kazanlak, Bulgaria, 6100
Alkermes Investigational Site
Lovech, Bulgaria, 5500
Alkermes Investigational Site
Novi Iskar, Bulgaria, 1280
Alkermes Investigational Site
Pazardzhik, Bulgaria, 4400
Alkermes Investigational Site
Sofia, Bulgaria, 1606
Alkermes Investigational Site
Tserova Koria, Bulgaria, 8260
Alkermes Investigational Site
Varna, Bulgaria, 9020
Alkermes Investigational Site
Vratsa, Bulgaria, 3000
Czech Republic
Alkermes Investigational Site
Brno-mesto, Czech Republic
Alkermes Investigational Site
Praha, Czech Republic
Sponsors and Collaborators
Alkermes, Inc.
Investigators
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Study Director: Bernard L. Silverman, MD Alkermes, Inc.

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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:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Naltrexone
Olanzapine
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
Alcohol Deterrents
Narcotic Antagonists
Sensory System Agents