A Study of ALKS 3831 in Adults With Schizophrenia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.
ClinicalTrials.gov Identifier:
NCT01903837
First received: July 5, 2013
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Schizophrenia
Drug: Samidorphan (Low Dose)
Drug: Samidorphan (Medium Dose)
Drug: Samidorphan (High Dose)
Drug: Placebo
Drug: Olanzapine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Alkermes, Inc.:

Primary Outcome Measures:
  • Change in Positive and Negative Syndrome Scale (PANSS) score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline


Secondary Outcome Measures:
  • Percent change in body weight from baseline to the end of Part A [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability of samidorphan (ALKS 33) [ Time Frame: 29 weeks ] [ Designated as safety issue: No ]
    Safety and tolerability will be assessed by number and percentage of subjects with adverse events (AEs).

  • Change in body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects exhibiting significant weight gain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Significant weight gain will include body weight gain greater than 7%

  • Change in Clinical Global Impressions - Severity (CGI-S) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: June 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Placebo
Drug: Olanzapine
Tablets taken once daily

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01903837

  Show 57 Study Locations
Sponsors and Collaborators
Alkermes, Inc.
Investigators
Study Director: Bernard L. Silverman, MD Alkermes, Inc.
  More Information

No publications provided

Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT01903837     History of Changes
Other Study ID Numbers: ALK3831-302
Study First Received: July 5, 2013
Last Updated: September 11, 2014
Health Authority: United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control

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

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Olanzapine
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 29, 2014