Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
169
Countries
3
Sites
7
Schizophrenia
To evaluate the efficacy of NBI-1117570 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults who need inpatient hospitalization.
Key facts
- Sponsor
- Neurocrine Biosciences Inc.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 8 Apr 2026 → ongoing
- Decision date (initial)
- 2026-03-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Neurocrine Biosciences, Inc.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Others, Safety, Efficacy
To evaluate the efficacy of NBI-1117570 compared with placebo on improving
behavioral and psychological symptoms of schizophrenia in adults who need inpatient hospitalization.
Secondary objectives 1
- To evaluate the safety and tolerability of NBI-1117570 in participants with schizophrenia.
Conditions and MedDRA coding
Schizophrenia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10039626 | Schizophrenia | 100000004873 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 1. 18 to 55 years of age
- 2. Primary diagnosis of schizophrenia ≥1 year before screening
- 3. Participant is experiencing an acute exacerbation or relapse of symptoms with onset less than 2 months before screening and currently requires hospitalization
- 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 5
- 1. Considered to be at imminent risk of suicide or injury to self or others
- 2. History of epilepsy, seizures, or convulsions
- 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
- 4. Currently taking prohibited medications
- 5. Pregnant or lactating
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score. This scale measures the severity of symptoms in people with schizophrenia.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD12608032 · Product
- Active substance
- NBI-1117570
- Substance synonyms
- HTL0022537
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 5 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NEUROCRINE BIOSCIENCES INC
- Paediatric formulation
- No
- Orphan designation
- No
PRD12608003 · Product
- Active substance
- NBI-1117570
- Substance synonyms
- HTL0022537
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 5 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NEUROCRINE BIOSCIENCES INC
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Neurocrine Biosciences Inc.
- Sponsor organisation
- Neurocrine Biosciences Inc.
- Address
- 6027 Edgewood Bend Court
- City
- San Diego
- Postcode
- 92130-8235
- Country
- United States
Scientific contact point
- Organisation
- Neurocrine Biosciences Inc.
- Contact name
- Neurocrine Medical Information Call Center
Public contact point
- Organisation
- Neurocrine Biosciences Inc.
- Contact name
- Neurocrine Medical Information Call Center
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Acm Global Laboratories Private Limited ORG-100054801
|
Mumbai, India | Laboratory analysis |
| Syneos Health Romania S.R.L. ORG-100051180
|
Bucharest, Romania | On site monitoring, Code 12, Code 2, Code 8 |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | On site monitoring, Code 12, Code 13, Code 2, Code 5, Code 8 |
Locations
3 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ongoing, recruiting | 24 | 3 |
| Poland | Authorised, recruitment pending | 25 | 2 |
| Romania | Authorised, recruitment pending | 24 | 2 |
| Rest of world
United Kingdom, Serbia
|
— | 96 | — |
Investigational sites
Multiprofile Hospital For Active Treatment Dr. Hristo Stambolski EOOD
Department of Psychiatry, Ulitsa Starozagorska 16, 6102, Kazanlik
State Psychiatric Hospital Pazardzhik
Dep for Active Treatment of males; of females; of males and females, Ulitsa Bolnichna 28, 4400, Pazardzhik
Multiprofile Hospital For Active Treatment - Targovishte AD
Department of Psychiatry, West District, Syuren Blvd 1, Targovishte
Uniwersyteckie Centrum Kliniczne
Klinika Psychiatrii Dorosłych, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Centrum Medyczne Hcp Sp. z o.o.
N/A, Ul. 28 Czerwca 1956 R. 194, 61-485, Poznan
Institutul De Psihiatrie Socola Iasi
Sectia 5 Acuti, Soseaua Bucium 36, 700282, Jassi
Spitalul Clinic Judetean Mures
Psychiatric Clinic I, Str Gh Marinescu Nr 46, 540136, Targu Mures
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Bulgaria | 2026-04-08 | 2026-04-08 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 29 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-521868-35-00_Redacted | 1.4 |
| Protocol (for publication) | D4_Patient facing documents_3rd party placeholder | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_ROU | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_GP Letter_BG_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GP Letter_ENG_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_Participant ID Card_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Informant_PL_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_PL_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_PL | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Informant_BG_Redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Informant_EN_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Informant_ENG_Redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Informant_RO_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BG_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_EN_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ENG_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_RO_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Follow-Up_EN | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Follow-Up_RO | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_BG | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_ENG | 1.2.0 |
| Subject information and informed consent form (for publication) | L2_OSIM_Participant ID Card_BG_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_OSIM_Participant ID Card_ENG_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BG_2025-521868-35-00_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ENG_2025-521868-35-00_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_2025-521868-35-00_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_RO_2025-521868-35-00_Redacted | 3.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-07 | Poland | Acceptable 2026-03-16
|
2026-03-23 |