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

NCT02634346 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 403

Last updated 2018-06-27

Study results available
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Summary

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

Conditions

Interventions

DRUG

ALK3831

Daily dosing

DRUG

Olanzapine

Daily dosing

DRUG

Placebo

Daily dosing

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • David McDonnell, MD · Alkermes, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-05-25
Completion
2017-06-07

Countries

  • United States
  • Bulgaria
  • Serbia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02634346 on ClinicalTrials.gov