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Trial record 1 of 1 for:    ALK3831-A303
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A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)

This study is currently recruiting participants.
Verified September 2017 by Alkermes, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02694328
First Posted: February 29, 2016
Last Update Posted: September 6, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Alkermes, Inc.
  Purpose
This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects with schizophrenia.

Condition Intervention Phase
Schizophrenia Drug: ALKS 3831 Drug: Olanzapine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Study to Evaluate Weight Gain of ALKS 3831 Compared to Olanzapine in Adults With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Alkermes, Inc.:

Primary Outcome Measures:
  • Percent change from baseline in body weight [ Time Frame: 24 weeks ]
  • Proportion of subjects with >/= 10% weight gain [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Percent change from baseline in body weight in early weight gain population [ Time Frame: 24 weeks ]
    Subjects who gain weight (>0 kg) at Week 1

  • Proportion of subjects with >/= 10% weight gain in early weight gain population [ Time Frame: 24 Weeks ]
    Subjects who gain weight (>0 kg) at Week 1

  • Proportion of subjects with >/= 7% weight gain [ Time Frame: 24 weeks ]
  • Incidence of Adverse Events (AEs) [ Time Frame: 24 weeks ]

Estimated Enrollment: 540
Study Start Date: February 2016
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALKS 3831
Administered as a coated bilayer tablet
Drug: ALKS 3831
Daily dosing
Active Comparator: Olanzapine
Administered as a coated bilayer tablet
Drug: Olanzapine
Daily dosing

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has a body mass index (BMI) of 18.0-30.0 kg/m^2, inclusive, at Visit 1 and Visit 2
  • Subject meets the DSM-5 criteria for a primary diagnosis of schizophrenia
  • Subject is appropriate for outpatient treatment; has no hospitalizations for acute exacerbations of schizophrenia within 6 months before Visit 1
  • Subject has maintained a stable body weight (change </= 5%) for at least 3 months prior to Visit 1 based on self-report
  • Additional criteria may apply

Exclusion Criteria:

  • Subject has any of the following psychiatric conditions per DSM-5 criteria:
  • Diagnosis of schizoaffective disorder or bipolar I or II disorder, or current, untreated or unstable major depressive disorder
  • Clinically significant cognitive difficulties present within the past 2 years that could interfere with participation in the study
  • Drug-induced or toxic psychosis
  • Any other psychiatric condition that could interfere with participation in the study
  • Subject poses a current suicide risk at Visit 1 or Visit 2 in the opinion of the investigator
  • Subject has inflammatory bowel disease or any other gastrointestinal disorder associated with weight loss, anorexia nervosa, or binge eating disorder
  • Additional criteria may apply
  Contacts and Locations
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): NCT02694328


Contacts
Contact: Premier Research 866-921-3155 ALKE3813CT@premier-research.com

  Show 66 Study Locations
Sponsors and Collaborators
Alkermes, Inc.
Investigators
Study Director: David McDonnell, MD Alkermes, Inc.
  More Information

Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02694328     History of Changes
Other Study ID Numbers: ALK3831-A303
First Submitted: February 24, 2016
First Posted: February 29, 2016
Last Update Posted: September 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Alkermes, Inc.:
Alkermes
ALKS 3831
Samidorphan
Schizophrenia
Olanzapine
Weight

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Olanzapine
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