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

• ClinicalTrials.gov Identifier: NCT02634346
• Recruitment Status: Completed
• First Posted: December 18, 2015
• Results First Posted: June 27, 2018
• Last Update Posted: June 27, 2018
• Sponsor: Alkermes, Inc.
• Information provided by (Responsible Party): Alkermes, Inc.

Study Description

Brief Summary:

This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation of schizophrenia.

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Drug: ALK3831; Drug: Olanzapine; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 403 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 Determine the Antipsychotic Efficacy and Safety of ALKS 3831 in Adult Subjects With Acute Exacerbation of Schizophrenia
• Actual Study Start Date: December 2015
• Actual Primary Completion Date: May 25, 2017
• Actual Study Completion Date: June 7, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: ALKS 3831; Administered as a coated bilayer tablet	Drug: ALK3831; Daily dosing
Active Comparator: Olanzapine; Administered as a coated bilayer tablet	Drug: Olanzapine; Daily dosing
Placebo Comparator: Placebo; Administered as a coated bilayer tablet	Drug: Placebo; Daily dosing

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 [ Time Frame: 4 weeks ]
   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 :

1. Change From Baseline in Clinical Global Impressions-Severity (CGIS) Score at Week 4 [ Time Frame: 4 weeks ]
   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.
2. Incidence of Adverse Events [ Time Frame: Approximately 4 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Arkansas

Alkermes Investigational Site

Little Rock, Arkansas, United States, 72211

Alkermes Investigational Site

Springdale, Arkansas, United States, 72764

United States, California

Alkermes Investigational Site

Culver City, California, United States, 90230

Alkermes Investigational Site

Garden Grove, California, United States, 92845

Alkermes Investigational Site

Lemon Grove, California, United States, 91945

Alkermes Investigational Site

Long Beach, California, United States, 90822

Alkermes Investigational Site

Orange, California, United States, 92868

Alkermes Investigational Site

San Diego, California, United States, 92103

United States, District of Columbia

Alkermes Investigational Site

Washington, District of Columbia, United States, 20016

United States, Florida

Alkermes Investigational Site

North Miami, Florida, United States, 33161

United States, Illinois

Alkermes Investigational Site

Chicago, Illinois, United States, 60640

United States, Missouri

Alkermes Investigational Site

Saint Louis, Missouri, United States, 63141

United States, Nevada

Alkermes Investigational Site

Las Vegas, Nevada, United States, 89102

United States, New Jersey

Alkermes Investigational Site

Marlton, New Jersey, United States, 08053

United States, Ohio

Alkermes Investigational Site

Dayton, Ohio, United States, 45417

United States, Texas

Alkermes Investigational Site

Dallas, Texas, United States, 75243

Bulgaria

Alkermes Investigational Site

Burgas, Bulgaria

Alkermes Investigational Site

Kazanlak, Bulgaria

Alkermes Investigational Site

Lovech, Bulgaria

Alkermes Investigational Site

Novi Iskar, Bulgaria

Alkermes Investigational Site

Plovdiv, Bulgaria

Alkermes Investigational Site

Veliko Tarnovo, Bulgaria

Alkermes Investigational Site

Vratsa, Bulgaria

Serbia

Alkermes Investigational Site

Belgrade, Serbia

Alkermes Investigational Site

Krabujevac, Serbia

Alkermes Investigational Site

Novi Knezevac, Serbia

Ukraine

Alkermes Investigational Site

Cherkasy, Ukraine

Alkermes Investigational Site

Kherson, Ukraine

Alkermes Investigational Site

Kiev, Ukraine

Alkermes Investigational Site

L'viv, Ukraine

Alkermes Investigational Site

Vinnytsia, Ukraine

Sponsors and Collaborators

Alkermes, Inc.

Investigators

• Study Director: David McDonnell, MD; Alkermes, Inc.

  Study Documents (Full-Text)

Documents provided by Alkermes, Inc.:

Study Protocol  [PDF] September 22, 2016

Statistical Analysis Plan  [PDF] June 23, 2017

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Alkermes, Inc.
• ClinicalTrials.gov Identifier: NCT02634346
• Other Study ID Numbers: ALKS-3831-A305
• First Posted: December 18, 2015
• Results First Posted: June 27, 2018
• Last Update Posted: June 27, 2018
• Last Verified: May 2018

Keywords provided by Alkermes, Inc.:

Alkermes; ALKS 3831; Samidorphan; Schizophrenia; Acute Exacerbation of Schizophrenia

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