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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ALKS 3831
Olanzapine
Sponsored by
Alkermes, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Alkermes, ALKS 3831, Samidorphan, Schizophrenia, Olanzapine, Weight

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ALKS 3831

Olanzapine

Arm Description

Administered as a coated bilayer tablet

Administered as a coated bilayer tablet

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Body Weight at Week 24
Percentage of Participants With >/= 10% Weight Gain at Week 24

Secondary Outcome Measures

Percentage of Participants With >/= 7% Weight Gain at Week 24
Number of Participants Experiencing of Adverse Events (AEs)

Full Information

First Posted
February 24, 2016
Last Updated
January 29, 2020
Sponsor
Alkermes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02694328
Brief Title
A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)
Official Title
A Phase 3 Study to Evaluate Weight Gain of ALKS 3831 Compared to Olanzapine in Adults With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 2, 2016 (Actual)
Primary Completion Date
November 7, 2018 (Actual)
Study Completion Date
November 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alkermes, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Alkermes, ALKS 3831, Samidorphan, Schizophrenia, Olanzapine, Weight

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
561 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALKS 3831
Arm Type
Experimental
Arm Description
Administered as a coated bilayer tablet
Arm Title
Olanzapine
Arm Type
Active Comparator
Arm Description
Administered as a coated bilayer tablet
Intervention Type
Drug
Intervention Name(s)
ALKS 3831
Intervention Description
Daily dosing
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Description
Daily dosing
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Body Weight at Week 24
Time Frame
Baseline and Week 24
Title
Percentage of Participants With >/= 10% Weight Gain at Week 24
Time Frame
Baseline and Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants With >/= 7% Weight Gain at Week 24
Time Frame
Baseline and Week 24
Title
Number of Participants Experiencing of Adverse Events (AEs)
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alkermes Medical Director
Organizational Affiliation
Alkermes, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alkermes Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Alkermes Investigational Site
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72764
Country
United States
Facility Name
Alkermes Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Alkermes Investigational Site
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Alkermes Investigational Site
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Alkermes Investigational Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Alkermes Investigational Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Alkermes Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Alkermes Investigational Site
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Alkermes Investigational Site
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
Alkermes Investigational Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Alkermes Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Alkermes Investigational Site
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
Alkermes Investigational Site
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Alkermes Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Alkermes Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Alkermes Investigational Site
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Alkermes Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Alkermes Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Alkermes Investigational Site
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Alkermes Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Alkermes Investigational Site
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Alkermes Investigational Site
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Alkermes Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Alkermes Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Alkermes Investigational Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Alkermes Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Alkermes Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Alkermes Investigational Site
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Alkermes Investigational Site
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Alkermes Investigational Site
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Alkermes Investigational Site
City
O'Fallon
State/Province
Missouri
ZIP/Postal Code
63368
Country
United States
Facility Name
Alkermes Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Alkermes Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Alkermes Investigational Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Alkermes Investigational Site
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Alkermes Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Alkermes Investigational Site
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Alkermes Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Alkermes Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Facility Name
Alkermes Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14615
Country
United States
Facility Name
Alkermes Investigational Site
City
Wards Island
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Facility Name
Alkermes Investigational Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Alkermes Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Alkermes Investigational Site
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Alkermes Investigational Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Alkermes Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
Alkermes Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Alkermes Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Alkermes Investigational Site
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Alkermes Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Alkermes Investigational Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Alkermes Investigational Site
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Alkermes Investigational Site
City
San Juan
ZIP/Postal Code
00926
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36305696
Citation
Correll CU, Stein E, Graham C, DiPetrillo L, Akerman S, Stanford AD, Jiang Y, Yagoda S, McDonnell D, Hopkinson C. Reduction in Multiple Cardiometabolic Risk Factors With Combined Olanzapine/Samidorphan Compared With Olanzapine: Post Hoc Analyses From a 24-Week Phase 3 Study. Schizophr Bull. 2023 Mar 15;49(2):454-463. doi: 10.1093/schbul/sbac144.
Results Reference
derived

Learn more about this trial

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

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