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

Schizophrenia Clinical Trial

Official title:

A Phase 3 Study to Determine the Antipsychotic Efficacy and Safety of ALKS 3831 in Adult Subjects With Acute Exacerbation of Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02634346
• Other study ID #: ALKS-3831-A305
• Status: Completed
• Phase: Phase 3
• Start date: December 2015
• Est. completion date: June 7, 2017

Study information

• Verified date: May 2018
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: June 7, 2017
• Est. primary completion date: May 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• ALK3831
Daily dosing
• Olanzapine
Daily dosing
• Placebo
Daily dosing

Locations

Country	Name	City	State
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
Serbia	Alkermes Investigational Site	Belgrade
Serbia	Alkermes Investigational Site	Krabujevac
Serbia	Alkermes Investigational Site	Novi Knezevac
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
United States	Alkermes Investigational Site	Chicago	Illinois
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	Garden Grove	California
United States	Alkermes Investigational Site	Las Vegas	Nevada
United States	Alkermes Investigational Site	Lemon Grove	California
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	North Miami	Florida
United States	Alkermes Investigational Site	Orange	California
United States	Alkermes Investigational Site	Saint Louis	Missouri
United States	Alkermes Investigational Site	San Diego	California
United States	Alkermes Investigational Site	Springdale	Arkansas
United States	Alkermes Investigational Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Secondary	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.	4 weeks
Secondary	Incidence of Adverse Events		Approximately 4 weeks