Clinical trial NCT02634346: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Alkermes
ALKS 3831
Samidorphan
Schizophrenia
Acute Exacerbation of Schizophrenia
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2015-12-18
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
timeFrame: 4 weeks
Secondary outcomes:
measure: Change From Baseline in Clinical Global Impressions-Severity (CGIS) Score at Week 4
timeFrame: 4 weeks
measure: Incidence of Adverse Events
timeFrame: Approximately 4 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Springdale
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Culver City
country: United States
facility: Alkermes Investigational Site
state: California
city: Garden Grove
country: United States
facility: Alkermes Investigational Site
state: California
city: Lemon Grove
country: United States
facility: Alkermes Investigational Site
state: California
city: Long Beach
country: United States
facility: Alkermes Investigational Site
state: California
city: Orange
country: United States
facility: Alkermes Investigational Site
state: California
city: San Diego
country: United States
facility: Alkermes Investigational Site
state: California
city: Washington
country: United States
facility: Alkermes Investigational Site
state: District of Columbia
city: North Miami
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Chicago
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Saint Louis
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Alkermes Investigational Site
state: Nevada
city: Marlton
country: United States
facility: Alkermes Investigational Site
state: New Jersey
city: Dayton
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Dallas
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Burgas
country: Bulgaria
facility: Alkermes Investigational Site
city: Kazanlak
country: Bulgaria
facility: Alkermes Investigational Site
city: Lovech
country: Bulgaria
facility: Alkermes Investigational Site
city: Novi Iskar
country: Bulgaria
facility: Alkermes Investigational Site
city: Plovdiv
country: Bulgaria
facility: Alkermes Investigational Site
city: Veliko Tarnovo
country: Bulgaria
facility: Alkermes Investigational Site
city: Vratsa
country: Bulgaria
facility: Alkermes Investigational Site
city: Belgrade
country: Serbia
facility: Alkermes Investigational Site
city: Krabujevac
country: Serbia
facility: Alkermes Investigational Site
city: Novi Knezevac
country: Serbia
facility: Alkermes Investigational Site
city: Cherkasy
country: Ukraine
facility: Alkermes Investigational Site
city: Kherson
country: Ukraine
facility: Alkermes Investigational Site
city: Kiev
country: Ukraine
facility: Alkermes Investigational Site
city: L'viv
country: Ukraine
facility: Alkermes Investigational Site
city: Vinnytsia
country: Ukraine
facility: Alkermes Investigational Site
Study officials:
affiliation: Alkermes, Inc.
name: David McDonnell, MD
role: STUDY_DIRECTOR
References:
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.