NCT07105098

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
284

participants targeted

Target at P50-P75 for phase_3 schizophrenia

Timeline
18mo left

Started Aug 2025

Geographic Reach
3 countries

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Aug 2025Nov 2027

First Submitted

Initial submission to the registry

July 29, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

August 11, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

July 29, 2025

Last Update Submit

April 10, 2026

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5

    Baseline, Week 5

Secondary Outcomes (1)

  • Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 5

    Baseline, Week 5

Study Arms (2)

NBI-1117568

EXPERIMENTAL

Participants will receive NBI-1117568 once daily (QD) orally from Day 1 to Day 35 for a total of 5 weeks.

Drug: NBI-1117568

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo QD orally from Day 1 to Day 35 for a total of 5 weeks.

Drug: Placebo

Interventions

NBI-1117568DRUG

NBI-1117568 will be administered per schedule specified in the arm description.

NBI-1117568
PlaceboDRUG

Placebo will be administered per schedule specified in the arm description.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Participant has 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Neurocrine Clinical Site

Culver City, California, 90230, United States

RECRUITING

Neurocrine Clinical Site

Garden Grove, California, 92845, United States

RECRUITING

Neurocrine Clinical Site

Riverside, California, 92506, United States

RECRUITING

Neurocrine Clinical Site

Atlanta, Georgia, 30328, United States

RECRUITING

Neurocrine Clinical Site

North Canton, Ohio, 44720, United States

RECRUITING

Neurocrine Clinical Site

Sliven, 8800, Bulgaria

RECRUITING

Neurocrine Clinical Site

Veliko Tarnovo, 5047, Bulgaria

WITHDRAWN

Neurocrine Clinical Site

Vratsa, 3001, Bulgaria

RECRUITING

Neurocrine Clinical Site

Brasov, 500123, Romania

RECRUITING

Neurocrine Clinical Site

Brasov, 507190, Romania

RECRUITING

Neurocrine Clinical Site

Bucharest, 41914, Romania

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Clinical Development Lead

    Neurocrine Biosciences

    STUDY DIRECTOR

Central Study Contacts

Neurocrine Medical Information Call Center

CONTACT

877-641-3461medinfo@neurocrine.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2025

First Posted

August 5, 2025

Study Start

August 11, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

US(5)RO(3)BU(3)