Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia

September 15, 2023 updated by: Neurocrine Biosciences

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, multi-arm, multi-stage inpatient study designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of NBI-1117568 compared with placebo in adult subjects with a primary diagnosis of schizophrenia, who are experiencing an acute exacerbation or relapse of symptoms.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

213

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Neurocrine Clinical Site
      • Rogers, Arkansas, United States, 72758
        • Recruiting
        • Neurocrine Clinical Site
    • California
      • Lemon Grove, California, United States, 91945
        • Recruiting
        • Neurocrine Clinical Site
      • Pico Rivera, California, United States, 90660
        • Recruiting
        • Neurocrine Clinical Site
      • San Diego, California, United States, 92123
        • Recruiting
        • Neurocrine Clinical Site
      • Torrance, California, United States, 90502
        • Recruiting
        • Neurocrine Clinical Site
    • Florida
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Neurocrine Clinical Site
      • Oakland Park, Florida, United States, 33334
        • Recruiting
        • Neurocrine Clinical Site
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • Recruiting
        • Neurocrine Clinical Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Neurocrine Clinical Site
    • New Jersey
      • Berlin, New Jersey, United States, 08053
        • Recruiting
        • Neurocrine Clinical Site
    • Ohio
      • North Canton, Ohio, United States, 44720
        • Recruiting
        • Neurocrine Clinical Site
    • Texas
      • Austin, Texas, United States, 78754
        • Recruiting
        • Neurocrine Clinical Site
      • DeSoto, Texas, United States, 75115
        • Recruiting
        • Neurocrine Clinical Site
      • Richardson, Texas, United States, 75080
        • Recruiting
        • Neurocrine Clinical Site

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Completed informed consent.
  • Subject has a primary diagnosis of schizophrenia.
  • The subject is experiencing an acute exacerbation or relapse of symptoms and currently requires hospitalization.
  • Subjects taking prohibited medications, including antipsychotics, must discontinue before study participation
  • Subject is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements.

Key Exclusion Criteria:

  • An unstable medical condition, chronic disease, or malignancy.
  • Considered by the investigator to be at imminent risk of suicide or injury to self or others.
  • Diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening.
  • Positive alcohol test or drug screen for disallowed substances.
  • Have a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the subject is not capable of adhering to the protocol requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Level A
Participant administered Dose Level A (6 weeks)
Drug: NBI-1117568
Active treatment with orally administered NBI-1117568
Experimental: Dose Level B
Participant administered Dose Level B (6 weeks)
Drug: NBI-1117568
Active treatment with orally administered NBI-1117568
Experimental: Dose Level C
Participant administered Dose Level C (6 weeks)
Drug: NBI-1117568
Active treatment with orally administered NBI-1117568
Experimental: Dose Level D
Participant administered Dose Level D (6 weeks)
Drug: NBI-1117568
Active treatment with orally administered NBI-1117568
Placebo Comparator: Placebo Schedule
Participant administered placebo (6 weeks)
Drug: Placebo
Placebo matching NBI-1117568

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at Week 6
Time Frame: Baseline and Week 6
The PANSS evaluates the severity of various symptoms of schizophrenia, and is commonly used to measure symptom reduction in patients taking antipsychotics. Each item is scored on a 7-point severity scale (1=absent; 2=minimal; 3=mild; 4=moderate; 5=moderate severe; 6=severe; 7=extreme). The PANSS total score is derived from the summation of each item. A higher score indicates greater severity.
Baseline and Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurocrine Biosciences

Investigators

  • Study Director: Clinical Development Lead, Neurocrine Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 14, 2022

First Submitted That Met QC Criteria

September 14, 2022

First Posted (Actual)

September 19, 2022

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBI-1117568-SCZ2028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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