Clinical trial • Phase II • Psychiatry
NBI-1117570 for Schizophrenia
Phase II trial of NBI-1117570 for Schizophrenia.
Overview
- Trial Therapeutic Area
- Psychiatry
- Trial Disease
- Schizophrenia
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 07-11-2025
- First CTIS Authorization Date
- 23-03-2026
Trial design
Randomised, placebo for nbi-1117570 (placebo); no dose or schedule specified in the available record-controlled Phase II trial across 7 sites in Bulgaria, Romania, Poland.
- Randomised
- Yes
- Comparator
- Placebo for nbi-1117570 (Placebo); no dose or schedule specified in the available record
- Target Sample Size
- 96
Eligibility
Recruits 96 Vulnerable population selected. Subject information and informed consent forms include both 'Main' and 'Informant' ICF versions indicating provision for informant consent when applicable. ICF/SIS documents are available in multiple languages (English, Bulgarian, Romanian, Polish). Participants are adults (18+)..
- Pregnancy Exclusion
- 5. Pregnant or lactating
- Vulnerable Population
- Vulnerable population selected. Subject information and informed consent forms include both 'Main' and 'Informant' ICF versions indicating provision for informant consent when applicable. ICF/SIS documents are available in multiple languages (English, Bulgarian, Romanian, Polish). Participants are adults (18+).
Inclusion criteria
- {"criterion_text":"- 1. 18 to 55 years of age"}
- {"criterion_text":"- 2. Primary diagnosis of schizophrenia ≥1 year before screening"}
- {"criterion_text":"- 3. Participant is experiencing an acute exacerbation or relapse of symptoms with onset less than 2 months before screening and currently requires hospitalization"}
- {"criterion_text":"- 4. Participant must have had a positive response to at least 1 antipsychotic therapy (other than clozapine) for the treatment of a prior acute relapse"}
Exclusion criteria
- {"criterion_text":"- 1. Considered to be at imminent risk of suicide or injury to self or others"}
- {"criterion_text":"- 2. History of epilepsy, seizures, or convulsions"}
- {"criterion_text":"- 3. 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"}
- {"criterion_text":"- 4. Currently taking prohibited medications"}
- {"criterion_text":"- 5. Pregnant or lactating"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score. This scale measures the severity of symptoms in people with schizophrenia.","definition_or_measurement_approach":"Change from baseline in PANSS total score; PANSS is a standard scale measuring severity of positive and negative symptoms in schizophrenia (as stated in the record)."}
Recruitment
- Planned Sample Size
- 96
- Recruitment Window Months
- 18
- Consent Approach
- Informed consent obtained using Main and Informant SIS and ICF documents; Informant ICF versions indicate use of informant consent when applicable (vulnerable psychiatric population). ICF/SIS documents available in English, Bulgarian, Romanian and Polish. Participants are adults (18+); no assent documents for minors are provided.
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 73
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 27-02-2026
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 24
- Number Of Sites
- 3
- Number Of Participants
- 24
Sites
- Site Name
- State Psychiatric Hospital Pazardzhik
- Department Name
- Dep for Active Treatment of males; of females; of males and females
- Contact Person Name
- Vasil Kotetarov
- Contact Person Email
- vasilkotetarov@abv.bg
- Site Name
- Multiprofile Hospital For Active Treatment Dr. Hristo Stambolski EOOD
- Department Name
- Department of Psychiatry
- Contact Person Name
- Ivan Nikov
- Contact Person Email
- I_nikov@yahoo.com
- Site Name
- Multiprofile Hospital For Active Treatment - Targovishte AD
- Department Name
- Department of Psychiatry
- Contact Person Name
- Veselka Vasileva
- Contact Person Email
- vesi_vasileva2002@yahoo.com
Romania
- Earliest CTIS Part Ii Submission Date
- 19-02-2026
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 32
- Number Of Sites
- 2
- Number Of Participants
- 24
Sites
- Site Name
- Institutul De Psihiatrie Socola Iasi
- Department Name
- Sectia 5 Acuti
- Contact Person Name
- Cristinel Ștefănescu
- Contact Person Email
- cristinel.stefanescu@gmail.com
- Site Name
- Spitalul Clinic Judetean Mures
- Department Name
- Psychiatric Clinic I
- Contact Person Name
- Adriana Mihai
- Contact Person Email
- dradrianamihai@yahoo.com
Poland
- Earliest CTIS Part Ii Submission Date
- 17-02-2026
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 34
- Number Of Sites
- 2
- Number Of Participants
- 25
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Psychiatrii Dorosłych
- Contact Person Name
- Wiesław Jerzy Cubała
- Contact Person Email
- cubala@gumed.edu.pl
- Site Name
- Centrum Medyczne Hcp Sp. z o.o.
- Contact Person Name
- Sylwia Szymkowiak
- Contact Person Email
- sylwia.szymkowiak@cmhcp.pl
Sponsor
Primary sponsor
- Full Name
- Neurocrine Biosciences Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Syneos Health Romania S.R.L.
- Responsibilities
- codes:1,12,2,8
- Name
- Syneos Health Inc.
- Responsibilities
- codes:1,12,13,2,5,8
Third parties
- {"country":"India","full_name":"Acm Global Laboratories Private Limited","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Romania","full_name":"Syneos Health Romania S.R.L.","duties_or_roles":"codes:1,12,2,8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"codes:1,12,13,2,5,8","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- NBI-1117570
- Active Substance
- NBI-1117570
- Modality
- Small molecule
- Routes Of Administration
- Oral (capsule)
- Route
- Oral
- Investigational Product Name
- Placebo for nbi-1117570
- Modality
- Other
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