NCT07288333RecruitingPhase 2
Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia
A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117570 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization
Source: ClinicalTrials.gov · Last updated 22 Jul 2026
Brief summary (registry, in English)
The primary objective for this study is to evaluate the efficacy of NBI-1117570 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults who warrant inpatient hospitalization.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 15 Dec 2025
- Start date
- 16 Feb 2026
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Neurocrine Biosciences
- Diseases
- Schizophrenia
- NCT number
- NCT07288333
- EU CT number
- 2025-521868-35-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 16 Feb 2026 to the primary completion date, 31 Aug 2027
- 15 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, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking prohibited medications.
Other illness
- History of epilepsy, seizures, or convulsions.
- Has orthostatic hypotension, or history of pulmonary hypertension, obstructive coronary artery disease, hypertrophic cardiomyopathy, myocardial infarction, coronary artery revascularization, heart failure, left ventricular hypertrophy, moderate or severe cardiac valvopathy, or other cardiovascular conditions or measures that would preclude participation.
Other
- Considered to be at imminent risk of suicide or injury to self or others.
- Pregnant or lactating.
- Note: Additional inclusion/exclusion criteria may apply, per protocol.
Who the study is looking for
- 18 to 55 years of age
- Primary diagnosis of schizophrenia ≥1 year before screening.
- Participant is experiencing an acute exacerbation or relapse of symptoms with onset less than 2 months before screening and currently requires hospitalization.
- Participant must have had a positive response to at least 1 antipsychotic therapy (other than clozapine) for the treatment of a prior acute relapse.
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Multiprofile Hospital For Active Treatment Dr. Hristo Stambolski EOOD Coordinator of this site? Confirm its status | Kazanlik | Bulgaria | Recruiting |
| State Psychiatric Hospital Pazardzhik Coordinator of this site? Confirm its status | Pazardzhik | Bulgaria | Recruiting |
| University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Recruiting |
| Multiprofile Hospital For Active Treatment - Targovishte AD Coordinator of this site? Confirm its status | Targovishte | Bulgaria | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
| Clinic for psychiatry Sveti Ivan Coordinator of this site? Confirm its status | Grad Zagreb | Croatia | Not yet recruiting |
| Klinika za psihijatriju Vrapce Coordinator of this site? Confirm its status | Grad Zagreb | Croatia | Not yet recruiting |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Coordinator of this site? Confirm its status | Bialystok | Poland | Not yet recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Not yet recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Not yet recruiting |
| Centrum Medyczne HCP Sp. z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Not yet 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 Judeţean Mureş Coordinator of this site? Confirm its status | Târgu Mureş | Romania | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.