NCT07105098RecruitingPhase 3
NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
A Global, 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
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 284 (estimated)
- First submitted
- 29 Jul 2025
- Start date
- 11 Aug 2025
- Primary completion date
- Nov 2027
- Lead sponsor
- Neurocrine Biosciences
- Diseases
- Schizophrenia
- NCT number
- NCT07105098
- EU CT number
- 2025-521215-39-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 284
- From 11 Aug 2025 to the primary completion date, Nov 2027
- 22 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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 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.
- Note: Other protocol-specified inclusion/exclusion criteria may apply.
Other
- Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| State Psychiatric Hospital - Lovech Coordinator of this site? Confirm its status | Lovech | Bulgaria | Recruiting |
| University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Recruiting |
| University Multiprofile Hospital For Active Treatment Saint Georgi EAD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| MBAL Dr. Ivan Seliminski Sliven AD Coordinator of this site? Confirm its status | Sliven | Bulgaria | Recruiting |
| Center For Mental Health Vratsa EOOD Coordinator of this site? Confirm its status | Vratsa | Bulgaria | Recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Gyoengyosi Bugat Pal Koerhaz Coordinator of this site? Confirm its status | Gyongyos | Hungary | Recruiting |
| Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Coordinator of this site? Confirm its status | Győr | Hungary | Recruiting |
| Spitalul Clinic De Psihiatrie Si Neurologie Brasov Coordinator of this site? Confirm its status | Brasov | Romania | Recruiting |
| Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Institutul De Psihiatrie Socola Iasi Coordinator of this site? Confirm its status | Jassi | Romania | Recruiting |
| Spitalul Clinic De Psihiatrie Si Neurologie Brasov Coordinator of this site? Confirm its status | Sanpetru | Romania | Recruiting |
| - Coordinator of this site? Confirm its status | Belgrade | Serbia | Withdrawn |
| - Coordinator of this site? Confirm its status | Gornja Toponica | Serbia | Recruiting |
| - Coordinator of this site? Confirm its status | Kragujevac | Serbia | Recruiting |
| - Coordinator of this site? Confirm its status | Atlanta | United States | Completed |
| - Coordinator of this site? Confirm its status | Culver City | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Garden Grove | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Hollywood | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| - Coordinator of this site? Confirm its status | North Canton | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Riverside | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.