NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
NCT ID: NCT06963034
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
284 participants
INTERVENTIONAL
2025-05-08
2027-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
NCT07105098
NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia
NCT07114874
Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia
NCT07288333
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia
NCT05545111
Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia
NCT07227818
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
NBI-1117568
Participants will receive NBI-1117568 once daily (QD) orally from Day 1 to Day 35 for a total of 5 weeks.
NBI-1117568
NBI-1117568 will be administered per schedule specified in the arm description.
Placebo
Participants will receive matching placebo QD orally from Day 1 to Day 35 for a total of 5 weeks.
Placebo
Placebo will be administered per schedule specified in the arm description.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NBI-1117568
NBI-1117568 will be administered per schedule specified in the arm description.
Placebo
Placebo will be administered per schedule specified in the arm description.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Neurocrine Biosciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Development Lead
Role: STUDY_DIRECTOR
Neurocrine Biosciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Neurocrine Clinical Site
Little Rock, Arkansas, United States
Neurocrine Clinical Site
Anaheim, California, United States
Neurocrine Clinical Site
Pico Rivera, California, United States
Neurocrine Clinical Site
San Diego, California, United States
Neurocrine Clinical Site
Sherman Oaks, California, United States
Neurocrine Clinical Site
Torrance, California, United States
Neurocrine Clinical Site
Hollywood, Florida, United States
Neurocrine Clinical Site
Miami Lakes, Florida, United States
Neurocrine Clinical Site
Atlanta, Georgia, United States
Neurocrine Clinical Site
Decatur, Georgia, United States
Neurocrine Clinical Site
Peachtree Corners, Georgia, United States
Neurocrine Clinical Site
Chicago, Illinois, United States
Neurocrine Clinical Site
Gaithersburg, Maryland, United States
Neurocrine Clinical Site
Watertown, Massachusetts, United States
Neurocrine Clinical Site
Marlton, New Jersey, United States
Neurocrine Clinical Site
Staten Island, New York, United States
Neurocrine Clinical Site
The Bronx, New York, United States
Neurocrine Clinical Site
Austin, Texas, United States
Neurocrine Clinical Site
DeSoto, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NBI-1117568-SCZ3029
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.