NCT07114874

Brief Summary

This study will evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for phase_3 schizophrenia

Timeline
68mo left

Started Jul 2025

Longer than P75 for phase_3 schizophrenia

Geographic Reach
4 countries

53 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 Progress13%
Jul 2025Dec 2031

Study Start

First participant enrolled

July 11, 2025

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2031

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

6.4 years

First QC Date

July 29, 2025

Last Update Submit

April 10, 2026

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Treatment-emergent Adverse Events

    Up to 36 months

Study Arms (1)

NBI-1117568

EXPERIMENTAL

Participants will receive NBI-1117568 once daily (QD) orally for up to 36 months.

Drug: NBI-1117568

Interventions

NBI-1117568DRUG

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

NBI-1117568

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
  • Participants taking prohibited medications, including antipsychotics, must discontinue before study participation
  • Participant must reside in a stable housing situation

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 (53)

Neurocrine Clinical Site

Bryant, Arkansas, 72022, United States

RECRUITING

Neurocrine Clinical Site

Little Rock, Arkansas, 72211, United States

RECRUITING

Neurocrine Clinical Site

Chino, California, 91710, United States

RECRUITING

Neurocrine Clinical Site

Culver City, California, 90230, United States

RECRUITING

Neurocrine Clinical Site

Garden Grove, California, 92845, United States

RECRUITING

Neurocrine Clinical Site

La Habra, California, 90631, United States

RECRUITING

Neurocrine Clinical Site

Lemon Grove, California, 91945, United States

RECRUITING

Neurocrine Clinical Site

Oceanside, California, 92056, United States

RECRUITING

Neurocrine Clinical Site

Pico Rivera, California, 90660, United States

RECRUITING

Neurocrine Clinical Site

Riverside, California, 92506, United States

RECRUITING

Neurocrine Clinical Site

San Diego, California, 92123, United States

RECRUITING

Neurocrine Clinical Site

Sherman, California, 91403, United States

RECRUITING

Neurocrine Clinical Site

Torrance, California, 90504, United States

RECRUITING

Neurocrine Clinical Site

West Hills, California, 91307, United States

RECRUITING

Neurocrine Clinical Site

Atlantis, Florida, 30328, United States

RECRUITING

Neurocrine Clinical Site

Aventura, Florida, 33108, United States

RECRUITING

Neurocrine Clinical Site

Doral, Florida, 33178, United States

RECRUITING

Neurocrine Clinical Site

Hollywood, Florida, 33024, United States

RECRUITING

Neurocrine Clinical Site

Maitland, Florida, 32751, United States

RECRUITING

Neurocrine Clinical Site

Miami, Florida, 33122, United States

RECRUITING

Neurocrine Clinical Site

Miami Lakes, Florida, 33016, United States

RECRUITING

Neurocrine Clinical Site

Tampa, Florida, 33629, United States

RECRUITING

Neurocrine Clinical Site

West Palm Beach, Florida, 33407, United States

RECRUITING

Neurocrine Clinical Site

Atlanta, Georgia, 30328, United States

RECRUITING

Neurocrine Clinical Site

Atlanta, Georgia, 30331, United States

RECRUITING

Neurocrine Clinical Site

Decatur, Georgia, 30030, United States

RECRUITING

Neurocrine Clinical Sites

Peachtree Corners, Georgia, 30071, United States

RECRUITING

Neurocrine Clinical Site

Chicago, Illinois, 60640, United States

RECRUITING

Neurocrine Clinical Site

Gaithersburg, Maryland, 20877, United States

RECRUITING

Neurocrine Clinical Site

Boston, Massachusetts, 02116, United States

RECRUITING

Neurocrine Clinical Site

Watertown, Massachusetts, 02472, United States

RECRUITING

Neurocrine Clinical Site

Flowood, Mississippi, 39232, United States

RECRUITING

Neurocrine Clinical Site

St Louis, Missouri, 63141, United States

RECRUITING

Neurocrine Clinical Site

Marlton, New Jersey, 08053, United States

RECRUITING

Neurocrine Clinical Site

Cedarhurst, New York, 11516, United States

RECRUITING

Neurocrine Clinical Site

New York, New York, 10029, United States

RECRUITING

Neurocrine Clinical Site

New York, New York, 10036, United States

RECRUITING

Neurocrine Clincial Site

Staten Island, New York, 10314, United States

RECRUITING

Neurocrine Clinical Sites

The Bronx, New York, 10461, United States

RECRUITING

Neurocrine Clinical Sites

North Canton, Ohio, 44720, United States

RECRUITING

Neurocrine Clinical Site

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Neurocrine Clinical Site

Austin, Texas, 78754, United States

RECRUITING

Neurocrine Clinical Site

DeSoto, Texas, 75115, United States

RECRUITING

Neurocrine Clinical Site

Houston, Texas, 77043, United States

RECRUITING

Neurocrine Clinical Sites

Orem, Utah, 84058, United States

RECRUITING

Neurocrine Clinical Site

Orem, Utah, 84058, United States

RECRUITING

Neurocrine Clinical Site

Bellevue, Washington, 98007, United States

RECRUITING

Neurocrine Clinical Site

Veliko Tarnovo, 5047, Bulgaria

WITHDRAWN

Neurocrine Clinical Site

Vratsa, 5047, Bulgaria

RECRUITING

Neurocrine Clinical Site

Brasov, 500123, Romania

RECRUITING

Neurocrine Clinical Site

Bucharest, 41914, Romania

RECRUITING

Neurocrine Clinical Site

Sânpetru, 507190, Romania

RECRUITING

Neurocrine Clinical Site

Belgrade, 11000, Serbia

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2025

First Posted

August 11, 2025

Study Start

July 11, 2025

Primary Completion (Estimated)

December 1, 2031

Study Completion (Estimated)

December 1, 2031

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

US(47)RO(3)SE(1)BU(2)