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NCT02694328 Clinical Trial

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

Schizophrenia Clinical Trial

Official title:
A Phase 3 Study to Evaluate Weight Gain of ALKS 3831 Compared to Olanzapine in Adults With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02694328
Other study ID # ALK3831-A303
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 2, 2016
Est. completion date November 7, 2018

Study information
Verified date January 2020
Source Alkermes, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 561
Est. completion date November 7, 2018
Est. primary completion date November 7, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ALKS 3831
Daily dosing
• Olanzapine
Daily dosing

Locations
Country Name City State
Puerto Rico Alkermes Investigational Site San Juan
Puerto Rico Alkermes Investigational Site San Juan
United States Alkermes Investigational Site Allentown Pennsylvania
United States Alkermes Investigational Site Anaheim California
United States Alkermes Investigational Site Atlanta Georgia
United States Alkermes Investigational Site Augusta Georgia
United States Alkermes Investigational Site Austin Texas
United States Alkermes Investigational Site Austin Texas
United States Alkermes Investigational Site Bellevue Washington
United States Alkermes Investigational Site Berlin New Jersey
United States Alkermes Investigational Site Brooklyn New York
United States Alkermes Investigational Site Canton Ohio
United States Alkermes Investigational Site Cerritos California
United States Alkermes Investigational Site Chicago Illinois
United States Alkermes Investigational Site Creve Coeur Missouri
United States Alkermes Investigational Site Culver City California
United States Alkermes Investigational Site Dallas Texas
United States Alkermes Investigational Site Dayton Ohio
United States Alkermes Investigational Site Decatur Georgia
United States Alkermes Investigational Site DeSoto Texas
United States Alkermes Investigational Site Flowood Mississippi
United States Alkermes Investigational Site Garden Grove California
United States Alkermes Investigational Site Glendale California
United States Alkermes Investigational Site Grand Rapids Michigan
United States Alkermes Investigational Site Houston Texas
United States Alkermes Investigational Site Jamaica New York
United States Alkermes Investigational Site Las Vegas Nevada
United States Alkermes Investigational Site Lauderhill Florida
United States Alkermes Investigational Site Little Rock Arkansas
United States Alkermes Investigational Site Long Beach California
United States Alkermes Investigational Site Marlton New Jersey
United States Alkermes Investigational Site Miami Florida
United States Alkermes Investigational Site Middleburg Heights Ohio
United States Alkermes Investigational Site National City California
United States Alkermes Investigational Site New York New York
United States Alkermes Investigational Site New York New York
United States Alkermes Investigational Site North Miami Florida
United States Alkermes Investigational Site O'Fallon Missouri
United States Alkermes Investigational Site Oakland California
United States Alkermes Investigational Site Oakland Park Florida
United States Alkermes Investigational Site Oceanside California
United States Alkermes Investigational Site Orange California
United States Alkermes Investigational Site Pico Rivera California
United States Alkermes Investigational Site Redlands California
United States Alkermes Investigational Site Rochester New York
United States Alkermes Investigational Site Saint Louis Missouri
United States Alkermes Investigational Site San Diego California
United States Alkermes Investigational Site San Diego California
United States Alkermes Investigational Site Springdale Arkansas
United States Alkermes Investigational Site Tampa Florida
United States Alkermes Investigational Site Temecula California
United States Alkermes Investigational Site Torrance California
United States Alkermes Investigational Site Wards Island New York
United States Alkermes Investigational Site Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Alkermes, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent Change From Baseline in Body Weight at Week 24 Baseline and Week 24
Primary Percentage of Participants With >/= 10% Weight Gain at Week 24 Baseline and Week 24
Secondary Percentage of Participants With >/= 7% Weight Gain at Week 24 Baseline and Week 24
Secondary Number of Participants Experiencing of Adverse Events (AEs) 24 weeks
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