Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
699
Countries
3
Sites
13
Schizophrenia
To evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.
Key facts
- Sponsor
- Neurocrine Biosciences Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 10 Dec 2025 → ongoing
- Decision date (initial)
- 2025-11-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Neurocrine Briosciences, Inc.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Others
To evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.
Secondary objectives 1
- To evaluate the long-term maintenance of effect of NBI-1117568 in adults with schizophrenia
Conditions and MedDRA coding
Schizophrenia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10039626 | Schizophrenia | 100000004873 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2025-521215-39-00 | 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 | Neurocrine Biosciences Inc. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- ≥18 and ≤65 years of age. Direct rollover participants must have been aged 18 to 65 (inclusive) at screening for the parent study.
- Primary diagnosis of schizophrenia.
Exclusion criteria 7
- Considered to be at imminent risk of suicide or injury to self or others.
- Any unstable or poorly controlled medical condition or chronic disease
- Any laboratory test results indicating clinically significant, poorly managed, or unmanaged undiagnosed disease.
- Certain heart conditions or uncontrolled blood pressure.
- History of epilepsy, seizures (except seizures during childhood caused by a fever), or convulsions.
- Currently taking medications that are not allowed.
- Pregnant or breastfeeding.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Occurrence of AEs during the Open-Label Treatment Period
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD12163091 · Product
- Active substance
- Direclidine
- Substance synonyms
- HTL0016878, NBI-1117568, Ethyl cis-2-[4-(1-methyl-1H-pyrazol-5-yl)piperidin-1-yl]-6-azaspiro[3.4]octane-6-carboxylate
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 156 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NEUROCRINE BIOSCIENCES INC
- Paediatric formulation
- No
- Orphan designation
- No
PRD12163084 · Product
- Active substance
- Direclidine
- Substance synonyms
- HTL0016878, NBI-1117568, Ethyl cis-2-[4-(1-methyl-1H-pyrazol-5-yl)piperidin-1-yl]-6-azaspiro[3.4]octane-6-carboxylate
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 156 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NEUROCRINE BIOSCIENCES INC
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Neurocrine Biosciences Inc.
- Sponsor organisation
- Neurocrine Biosciences Inc.
- Address
- 12780 El Camino Real
- City
- San Diego
- Postcode
- 92130-2042
- 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 9
| Organisation | City, country | Duties |
|---|---|---|
| Verified Clinical Trials LLC ORG-100045692
|
Garden City, United States | Other |
| Arup Laboratories Inc. ORG-100041750
|
Salt Lake City, United States | Other |
| Dr. Wisplinghoff Laboratory ORL-000016387
|
Koln, Germany | Other |
| LabConnect GmbH ORG-100047696
|
Cologne, Germany | Laboratory analysis |
| Etymax Limited ORG-100047823
|
London, United Kingdom | Other |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| Cronos Clinical Consulting Services, Inc. ORL-000014906
|
Parsippany, United States | Other |
| Premier Research International LLC ORG-100054043
|
Morrisville, United States | On site monitoring, Code 12, Code 13, Code 2, Code 5 |
| Suvoda LLC ORL-000014907
|
Conshohocken, United States | Other |
Locations
3 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ongoing, recruiting | 67 | 5 |
| Hungary | Authorised, recruitment pending | 35 | 2 |
| Romania | Ongoing, recruiting | 52 | 6 |
| Rest of world
Serbia, United States
|
— | 545 | — |
Investigational sites
MBAL Dr. Ivan Seliminski - Sliven AD
Psychiatry, Bulevard Hristo Botev 1, 8801, Sliven
State Psychiatric Hospital Tserova Koria
Department for Active Treatment of Severe Psychosis – males/females, Tzerova Koria Street Vtora 27, 5047, Veliko Tarnovo
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
First Psychiatric Clinic - Psychiatry, Ulitsa Georgi Kochev 8a, 5803, Pleven
Center For Mental Health Vratsa EOOD
Department of General Psychiatry, Belasita Str 1, 3000, Vratsa
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
First Psychiatric Clinic - Psychiatry, Ulitsa Vladimir Vazov 91, 5804, Pleven
Dr. Mathe Es Tarsa Bt.
Psychiatry, Szechenyi Ut 8, 6300, Kalocsa
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Psychiatry, Mentalhygiene and Addictology, Vasvari Pal Utca 2-4, 9024, Gyor
Institutul De Psihiatrie Socola Iasi
Psychiatry II Clinical Department, Soseaua Bucium 36, 700282, Jassi
Centru De Evaluare Si Tratament A Toxicodependentelor Pentru Tineri Sf. Stelian
Psychiatry Clinical Department, Strada Ing Cristian Pascal 25-27 Sector 6, 060222, Bucharest
Spitalul Clinic De Psihiatrie Si Neurologie Brasov
Psychiatry II Clinical Department, Strada Prundului 7-9, 500123, Brasov
Spitalul Clinic De Psihiatrie Si Neurologie Brasov
Psychiatry III Clinical Department, Str Meschendorfer Nr 443a, 507190, Sanpetru
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Psychiatry IX Clinical Department, Soseaua Berceni 10, 041915, Bucharest
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Psychiatry I Clinical Department, Soseaua Berceni 10, 041915, Bucharest
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 | 2025-12-22 | 2026-03-02 | |||
| Romania | 2025-12-10 | 2026-03-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 54 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-521216-19-00_redacted | 0.1.1 |
| Protocol (for publication) | D1_Protocol_handwritten signature_2025-521216-19-00_redacted | 0.1.1 |
| Protocol (for publication) | D4 Scale Abnormal Involuntary Movement_bg | 1.0 |
| Protocol (for publication) | D4 Scale Abnormal Involuntary Movement_hu | 1.0 |
| Protocol (for publication) | D4 Scale Abnormal Involuntary Movement_ro | 1.0 |
| Protocol (for publication) | D4 Scale Abnormal Involuntary Movement_en_Redacted | 1.0 |
| Protocol (for publication) | D4 Scale Clinical Global Impression of Severity_en_Redacted | 1.0 |
| Protocol (for publication) | D4 Scale Clinical Global Impression of Severity_ro | 1.0 |
| Protocol (for publication) | D4 Scale placeholder | n/a |
| Protocol (for publication) | D4 Scale_Modified Simpson Angus Scale_bg | 1.0 |
| Protocol (for publication) | D4 Scale_Modified Simpson Angus Scale_en_Redacted | 1.0 |
| Protocol (for publication) | D4 Scale_Modified Simpson Angus Scale_hu | 1.0 |
| Protocol (for publication) | D4 Scale_Modified Simpson Angus Scale_ro | 1.0 |
| Protocol (for publication) | D4 Scale_SIPSP Interview Guide_bg_redacted | 1.0 |
| Protocol (for publication) | D4 Scale_SIPSP Interview Guide_en_Redacted | 1.0 |
| Protocol (for publication) | D4 Scale_SIPSP Interview Guide_hu_redacted | 1.0 |
| Protocol (for publication) | D4 Scale_SIPSP Interview Guide_ro | 1.0 |
| Recruitment arrangements (for publication) | K1_GP Letter_ENG_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K1_GP Letter_ROM_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Romania_IC Patient Recruitment Procedure_ENG | 1.0 |
| Recruitment arrangements (for publication) | K1_Romania_IC Patient Recruitment Procedure_ROM | 1.0 |
| Recruitment arrangements (for publication) | K2_GP Letter_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_GP Letter_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_ENG_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_ROM_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_Romania_Pregnancy Follow-up Authorization ICF_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L1_Romania_Pregnancy Follow-up Authorization ICF_ROM | 1.0 |
| Subject information and informed consent form (for publication) | L1_Romania_Scout ICF_ENG_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_Romania_Scout ICF_ROM_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_Romania_VCT ICF EU_ENG_Redacted | 2021-6-N-c |
| Subject information and informed consent form (for publication) | L1_Romania_VCT ICF EU_ROM_Redacted | 2021-6-N-c |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF VCT_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF VCT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Follow Up Authorization_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy FU ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy FU ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Scout_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_VCT_Redacted | 2021-6-N-c |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject ID card | 2.0 |
| Subject information and informed consent form (for publication) | L2_Patient Emergency Card V1 22May2025 | 1 |
| Subject information and informed consent form (for publication) | L2_Romania_Participant Emergency Card_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L2_Romania_Participant Emergency Card_ROM | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-521216-19-00_bg_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-521216-19-00_en_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-521216-19-00_hu_redacted | 1.1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-521216-19-00_ro_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_HUN_2025-521216-19-00_en_redacted | 1.1 |
| Synopsis of the protocol (for publication) | D4 Scale Clinical Global Impression of Severity_bg | 1.0 |
| Synopsis of the protocol (for publication) | D4 Scale Clinical Global Impression of Severity_hu | 1.0 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-25 | Romania | Acceptable 2025-11-17
|
2025-11-21 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-12 | Romania | Acceptable 2025-11-17
|
2025-12-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-12-12 | Acceptable | 2026-01-30 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-05-07 | Acceptable | 2026-06-01 |