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A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ALK3831
Olanzapine
Placebo
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, Acute Exacerbation of Schizophrenia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has a body mass index (BMI) of 18.0 - 40.0 kg/m^2
  • Meets criteria for the diagnosis of schizophrenia
  • Resides in a stable living situation when not hospitalized
  • Is willing and able to provide government-issued identification
  • Additional criteria may apply

Exclusion Criteria:

  • Has had a psychiatric hospitalization for more than 30 days during the 90 days before screening
  • Subject initiated first antipsychotic treatment within the past 12 months, or <1 year has elapsed since the initial onset of active-phase of schizophrenia symptoms
  • Subject poses a current suicide risk
  • Subject has a history of treatment resistance
  • Subject has a history of poor or inadequate response to treatment with olanzapine
  • Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2-month period prior to screening
  • Subject has a diagnosis of moderate or severe alcohol or drug use disorder
  • Subject has a positive urine drug screen for opioids, amphetamine/methamphetamine, phencyclidine, or cocaine at screening
  • 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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

ALKS 3831

Olanzapine

Placebo

Arm Description

Administered as a coated bilayer tablet

Administered as a coated bilayer tablet

Administered as a coated bilayer tablet

Outcomes

Primary Outcome Measures

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and Week 4.

Secondary Outcome Measures

Change From Baseline in Clinical Global Impressions-Severity (CGIS) Score at Week 4
The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients". Results indicate a change in CGI-S score from baseline to Week 4 based on the observed data. Change is calculated between the baseline visit and Week 4.
Incidence of Adverse Events

Full Information

First Posted
December 16, 2015
Last Updated
May 25, 2018
Sponsor
Alkermes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02634346
Brief Title
A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)
Official Title
A Phase 3 Study to Determine the Antipsychotic Efficacy and Safety of ALKS 3831 in Adult Subjects With Acute Exacerbation of Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
May 25, 2017 (Actual)
Study Completion Date
June 7, 2017 (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 the efficacy of ALKS 3831 in adult subjects with acute exacerbation of 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, Acute Exacerbation of Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
403 (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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered as a coated bilayer tablet
Intervention Type
Drug
Intervention Name(s)
ALK3831
Intervention Description
Daily dosing
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Description
Daily dosing
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Daily dosing
Primary Outcome Measure Information:
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
Description
This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and Week 4.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Clinical Global Impressions-Severity (CGIS) Score at Week 4
Description
The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients". Results indicate a change in CGI-S score from baseline to Week 4 based on the observed data. Change is calculated between the baseline visit and Week 4.
Time Frame
4 weeks
Title
Incidence of Adverse Events
Time Frame
Approximately 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has a body mass index (BMI) of 18.0 - 40.0 kg/m^2 Meets criteria for the diagnosis of schizophrenia Resides in a stable living situation when not hospitalized Is willing and able to provide government-issued identification Additional criteria may apply Exclusion Criteria: Has had a psychiatric hospitalization for more than 30 days during the 90 days before screening Subject initiated first antipsychotic treatment within the past 12 months, or <1 year has elapsed since the initial onset of active-phase of schizophrenia symptoms Subject poses a current suicide risk Subject has a history of treatment resistance Subject has a history of poor or inadequate response to treatment with olanzapine Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2-month period prior to screening Subject has a diagnosis of moderate or severe alcohol or drug use disorder Subject has a positive urine drug screen for opioids, amphetamine/methamphetamine, phencyclidine, or cocaine at screening Additional criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David McDonnell, MD
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
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
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
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
Orange
State/Province
California
ZIP/Postal Code
92868
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
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
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
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Alkermes Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
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
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
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
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Alkermes Investigational Site
City
Burgas
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Kazanlak
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Lovech
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Novi Iskar
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Plovdiv
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Veliko Tarnovo
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Vratsa
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Belgrade
Country
Serbia
Facility Name
Alkermes Investigational Site
City
Krabujevac
Country
Serbia
Facility Name
Alkermes Investigational Site
City
Novi Knezevac
Country
Serbia
Facility Name
Alkermes Investigational Site
City
Cherkasy
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
Kherson
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
Kiev
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
L'viv
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
Vinnytsia
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
32141723
Citation
Potkin SG, Kunovac J, Silverman BL, Simmons A, Jiang Y, DiPetrillo L, McDonnell D. Efficacy and Safety of a Combination of Olanzapine and Samidorphan in Adult Patients With an Acute Exacerbation of Schizophrenia: Outcomes From the Randomized, Phase 3 ENLIGHTEN-1 Study. J Clin Psychiatry. 2020 Mar 3;81(2):19m12769. doi: 10.4088/JCP.19m12769.
Results Reference
derived

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A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)

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