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A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 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: NCT02634346
Recruitment Status : Completed
First Posted : December 18, 2015
Results First Posted : June 27, 2018
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Olanzapine

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




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 ]


Information from the National Library of Medicine

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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

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): NCT02634346


Locations
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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
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02634346    
Other Study ID Numbers: ALKS-3831-A305
First Posted: December 18, 2015    Key Record Dates
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:
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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