Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)

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: NCT02694328
Recruitment Status : Completed
First Posted : February 29, 2016
Results First Posted : February 10, 2020
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Brief Summary:
This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects with schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: ALKS 3831 Drug: Olanzapine Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 561 participants
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
Actual Study Start Date : March 2, 2016
Actual Primary Completion Date : November 7, 2018
Actual Study Completion Date : November 7, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Percent Change From Baseline in Body Weight at Week 24 [ Time Frame: Baseline and Week 24 ]
  2. Percentage of Participants With >/= 10% Weight Gain at Week 24 [ Time Frame: Baseline and Week 24 ]

Secondary Outcome Measures :
  1. Percentage of Participants With >/= 7% Weight Gain at Week 24 [ Time Frame: Baseline and Week 24 ]
  2. Number of Participants Experiencing of Adverse Events (AEs) [ Time Frame: 24 weeks ]


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.


Layout table for eligibility information
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

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


Locations
Show Show 54 study locations
Sponsors and Collaborators
Alkermes, Inc.
Investigators
Layout table for investigator information
Study Director: Alkermes Medical Director Alkermes, Inc.
  Study Documents (Full-Text)

Documents provided by Alkermes, Inc.:
Study Protocol  [PDF] September 18, 2018
Statistical Analysis Plan  [PDF] September 18, 2018

Layout table for additonal information
Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02694328    
Other Study ID Numbers: ALK3831-A303
First Posted: February 29, 2016    Key Record Dates
Results First Posted: February 10, 2020
Last Update Posted: February 10, 2020
Last Verified: January 2020
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:
Layout table for 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