RECRUITING

NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia

Description

The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.

Conditions

Schizophrenia
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Related Conditions:

Schizophrenia

Study Overview

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Study Details

Study overview

The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization

NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia

Condition
Schizophrenia
Intervention / Treatment

-

Contacts and Locations

Little Rock

Neurocrine Clinical Site, Little Rock, Arkansas, United States, 72211

Pico Rivera

Neurocrine Clinical Site, Pico Rivera, California, United States, 90660

San Diego

Neurocrine Clinical Site, San Diego, California, United States, 92123

Miami Lakes

Neurocrine Clinical Site, Miami Lakes, Florida, United States, 33016

Marlton

Neurocrine Clinical Site, Marlton, New Jersey, United States, 08053

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participant has a primary diagnosis of schizophrenia
  • * Participant is experiencing an acute exacerbation or relapse of symptoms and currently warrants hospitalization.
  • * Participants taking prohibited medications, including antipsychotics, must discontinue before study participation
  • * Participant is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements
  • * Participant has known hypersensitivity to any component of the formulation of NBI-1117568.
  • * Participant has an unstable or poorly controlled medical condition or chronic disease
  • * Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others
  • * Participant has a diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening
  • * Participant has a positive alcohol test or drug screen for disallowed substances
  • * Participants have a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the participant is not capable of adhering to the protocol requirements.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Neurocrine Biosciences,

Clinical Development Lead, STUDY_DIRECTOR, Neurocrine Biosciences

Study Record Dates

2027-10