Evaluation of NBI-1117568 in Inpatient Adults with Schizophrenia

2025-521215-39-00 Protocol NBI-1117568-SCZ3030 Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 8 Dec 2025 · Status Ongoing, recruiting · 3 EU/EEA countries · 15 sites · Protocol NBI-1117568-SCZ3030

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruiting
Participants planned 284
Countries 3
Sites 15

Schizophrenia

To evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults

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
8 Dec 2025 → ongoing
Decision date (initial)
2025-11-10
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Neurocrine Biosciences, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Efficacy, Therapy

To evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults

Secondary objectives 1

  1. To evaluate the safety and tolerability of NBI-1117568 in adults with schizophrenia

Conditions and MedDRA coding

Schizophrenia

VersionLevelCodeTermSystem organ class
21.1 LLT 10001064 Acute schizophrenia 10037175

Regulatory references

Scientific advice from competent authorities
Food And Drug Administration
Plan to share IPD
No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. ≥18 and ≤65 years of age.
  2. Primary diagnosis of schizophrenia.
  3. Experiencing a sudden worsening or relapse of symptoms starting <2 months before screening and currently warrants hospitalization.

Exclusion criteria 7

  1. Considered to be at imminent risk of suicide or injury to self or others.
  2. Any unstable or poorly controlled medical condition or chronic disease.
  3. Any laboratory test results indicating clinically significant, poorly managed, or unmanaged undiagnosed disease.
  4. Certain heart conditions or uncontrolled blood pressure.
  5. History of epilepsy, seizures (except seizures during childhood caused by a fever), or convulsions.
  6. Currently taking medications that are not allowed.
  7. Pregnant or breastfeeding.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Change from baseline in PANSS total score at Week 5

Secondary endpoints 1

  1. Change from baseline in CGI-S score at Week 5

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

NBI-1117568

PRD12163091 · Product

Active substance
Direclidine
Substance synonyms
Ethyl cis-2-[4-(1-methyl-1H-pyrazol-5-yl)piperidin-1-yl]-6-azaspiro[3.4]octane-6-carboxylate, HTL0016878, NBI-1117568
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
5 Week(s)
Authorisation status
Not Authorised
MA holder
NEUROCRINE BIOSCIENCES INC
Paediatric formulation
No
Orphan designation
No

NBI-1117568

PRD12163084 · Product

Active substance
Direclidine
Substance synonyms
Ethyl cis-2-[4-(1-methyl-1H-pyrazol-5-yl)piperidin-1-yl]-6-azaspiro[3.4]octane-6-carboxylate, HTL0016878, NBI-1117568
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
5 Week(s)
Authorisation status
Not Authorised
MA holder
NEUROCRINE BIOSCIENCES INC
Paediatric formulation
No
Orphan designation
No

Placebo 1

NBI-1117568 Placebo Capsule

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.

18 Total trials 11 Recruiting 6 Ended
Commercial
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 15

OrganisationCity, countryDuties
Sudova LLC
ORL-000014469
 Conshohocken, United States Interactive response technologies (IRT)
LabConnect GmbH
ORG-100047696
 Cologne, Germany Laboratory analysis
Medidata Solutions Inc.
ORG-100016256
 New York, United States E-data capture
Arup Laboratories Inc.
ORG-100041750
 Salt Lake City, United States Other
Etymax Limited
ORG-100047823
 London, United Kingdom Other
Clario Medical Imaging Inc.
ORG-100052770
 Seattle, United States Other
Premier Research International LLC
ORG-100054043
 Morrisville, United States On site monitoring, Code 12, Code 13, Code 2, Code 5
Verified Clinical Trials LLC
ORG-100045692
 Garden City, United States Other
Syneos Health Inc.
ORG-100008382
 Princeton, United States Other
Cytel Inc.
ORG-100042560
 Cambridge, United States Other
Labor Dr. Wisplinghoff GbR
ORG-100046123
 Cologne, Germany Other
Scout Clinical
ORG-100042228
 Dallas, United States Other
Cronos Clinical Consulting Services, Inc.
ORL-000014492
 Parsippany, United States Other
YES Print
ORL-000013530
 Hants, United Kingdom Other
Clinical365 LLC
ORL-000017992
 Valencia, United States Other

Sponsor responsibilities

Article 77 compliance
Neurocrine Biosciences Inc.
Contact point sponsor
Neurocrine Biosciences Inc.
Article 77 implementation
Neurocrine Biosciences Inc.

Locations

3 EU/EEA countries · 15 investigational sites

By country

CountryMS statusPlanned subjectsSites
Bulgaria Ongoing, recruiting 57 4
Hungary Authorised, recruiting 1 5
Romania Ongoing, recruiting 83 6
Rest of world
United States, Serbia
 — 143 —

Investigational sites

Bulgaria

4 sites · Ongoing, recruiting
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
First Psychiatric Clinic - Psychiatry, Ulitsa Georgi Kochev 8a, 5803, Pleven
MBAL Dr. Ivan Seliminski - Sliven AD
Psychiatry, Bulevard Hristo Botev 1, 8801, Sliven
Center For Mental Health Vratsa EOOD
Department of General Psychiatry, Belasita Str 1, 3000, Vratsa
State Psychiatric Hospital Tserova Koria
Department for Active Treatment of Severe Psychosis – males and females, Tzerova Koria Street Vtora 27, 5047, Veliko Tarnovo

Hungary

5 sites · Authorised, recruiting
Gyoengyosi Bugat Pal Koerhaz
Psychiatry, Dozsa Gyorgy Utca 20-22, 3200, Gyongyos
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Psychiatry, Mentalhygiene and Addictology, Vasvari Pal Utca 2-4, 9024, Gyor
Clinexpert Kft.
NA, Kaszasdulo Utca 5, 1033, Budapest III
Bacs-Kiskun Varmegyei Oktatokorhaz
Psychiatry, Kossuth Lajos Utca 34, 6300, Kalocsa
Semmelweis University
Psychiatry and Psychotheraphy, Balassa J Utca 6, 1083, Budapest

Romania

6 sites · Ongoing, recruiting
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Psychiatry I Clinical Department, Soseaua Berceni 10, 041915, Bucharest
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 Prof.Dr.Alexandru Obregia
Psychiatry IX Clinical Department, Soseaua Berceni 10, 041915, Bucharest
Institutul De Psihiatrie Socola Iasi
Psychiatry III Clinical Department, Soseaua Bucium 36, 700282, Jassi
Spitalul Clinic De Psihiatrie Si Neurologie Brasov
Psychiatry III Clinical Department, Str Meschendorfer Nr 443a, 507190, Sanpetru

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Bulgaria 2025-12-08 2026-01-13
Hungary 2026-04-30
Romania 2025-12-08 2025-12-19

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 62 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1 Placebo Justification 20255212153900 Redacted 1.0
Protocol (for publication) D1 Protocol 20255212153900 Redacted 0.1
Protocol (for publication) D1 Protocol Addendum 20255212153900_Placeholder n/a
Protocol (for publication) D1 Protocol handwritten signature 20255212153900 Redacted 0.1
Protocol (for publication) D4 Scale Abnormal Involuntary Movement_bu 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 Clinical Global Impression of Severity_bu 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_hu 1.0
Protocol (for publication) D4 Scale Clinical Global Impression of Severity_ro 1.0
Protocol (for publication) D4 Scale Modified Simpson Angus_bu 1.0
Protocol (for publication) D4 Scale Modified Simpson Angus_en_Redacted 1.0
Protocol (for publication) D4 Scale Modified Simpson Angus_hu 1.0
Protocol (for publication) D4 Scale Modified Simpson Angus_ro 1.0
Protocol (for publication) D4 Scale placeholder_4 n/a
Protocol (for publication) D4 Scale placeholder_6 n/a
Protocol (for publication) D4_Scale Abnormal Involuntary Movement_en_Redacted 1.0
Protocol (for publication) D4_Scale placeholder_1 n/a
Protocol (for publication) D4_Scale placeholder_2 n/a
Protocol (for publication) D4_Scale placeholder_3 n/a
Protocol (for publication) D5 Outline of all active trials with the same IMP 20255212153900 n/a
Recruitment arrangements (for publication) K1_Recruitment and Informed consent procedure_1_23May2025 1.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements 1
Recruitment arrangements (for publication) K1_Romania_GP Letter_ENG_Redacted 1
Recruitment arrangements (for publication) K1_Romania_GP Letter_ROM_Redacted 1
Recruitment arrangements (for publication) K1_Romania_Recruitment Arrangements_ENG 1
Recruitment arrangements (for publication) K1_Romania_Recruitment Arrangements_ROM 1
Recruitment arrangements (for publication) K2_GP Letter_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment material_GP letter_1_29May2025_Redacted 1.0
Subject information and informed consent form (for publication) L1 SIS and ICF VCT_Redacted N/A
Subject information and informed consent form (for publication) L1_Romania_Designated_Study_Partner_ICF_ENG_Redacted 2.0
Subject information and informed consent form (for publication) L1_Romania_Designated_Study_Partner_ICF_ROM_Redacted 2.0
Subject information and informed consent form (for publication) L1_Romania_Main_ICF_ENG_Redacted 2.0
Subject information and informed consent form (for publication) L1_Romania_Main_ICF_ROM_Redacted 2.0
Subject information and informed consent form (for publication) L1_Romania_Pregnancy Follow-up Authorization ICF_ENG 1
Subject information and informed consent form (for publication) L1_Romania_Pregnancy Follow-up Authorization ICF_ROM 1
Subject information and informed consent form (for publication) L1_Romania_Scout ICF_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_Redacted 2021-6-N-c
Subject information and informed consent form (for publication) L1_Romania_VCT ICF_ROM_Redacted 2021-6-N-c
Subject information and informed consent form (for publication) L1_SIS and ICF VCT_Redacted N/A
Subject information and informed consent form (for publication) L1_SIS and ICF_Designated Partner_v2_23June2025_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Designated Study Patner_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Designated Study Patner_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_Redacted 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnancy_v2_25June2025_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner ICF_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner ICF_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Scout_Redacted_v1_25Jun2025 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_VCT_2021_Redacted 1.0
Subject information and informed consent form (for publication) L2_Participant Emergency Card 1
Subject information and informed consent form (for publication) L2_Romania_Pat_Em_Card_ENG 1
Subject information and informed consent form (for publication) L2_Romania_Pat_Em_Card_ROM 1
Subject information and informed consent form (for publication) L2_Subject ID card_v1_29May2025 1.0
Synopsis of the protocol (for publication) D1 Protocol Synopsis 2025 521215 39 00_en_Redacted 1.1
Synopsis of the protocol (for publication) D1 Protocol Synopsis 20255212153900 bu Redacted 1.0
Synopsis of the protocol (for publication) D1 Protocol Synopsis 20255212153900 en_Redacted 1.0
Synopsis of the protocol (for publication) D1 Protocol Synopsis 20255212153900 hu Redacted 1.1
Synopsis of the protocol (for publication) D1 Protocol Synopsis 20255212153900 ro Redacted 1.0

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-07-11 Romania Acceptable
2025-11-03
 2025-11-07
2 SUBSTANTIAL MODIFICATION SM-1 2025-11-19 Acceptable 2026-02-02
3 NON SUBSTANTIAL MODIFICATION NSM-2 2026-02-24 Romania Acceptable 2026-02-24

Related clinical trials