Clinical trial • Phase III • Psychiatry
DIRECLIDINE for Schizophrenia
Phase III trial of DIRECLIDINE for Schizophrenia. open-label, none/not specified-controlled. 545 participants.
Overview
- Trial Therapeutic Area
- Psychiatry
- Trial Disease
- Schizophrenia
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 25-07-2025
- First CTIS Authorization Date
- 21-11-2025
Trial design
open-label, none/not specified-controlled Phase III trial across 12 sites in Hungary, Romania, Bulgaria.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 545
Eligibility
Recruits 545 Vulnerable population selected (isVulnerablePopulationSelected = true). Informed consent materials (Subject information and informed consent forms L1) are provided (documents listed for multiple countries and languages including English, Romanian, Hungarian, Bulgarian). No specific assent procedures for minors are described (minors are excluded by age criteria)..
- Pregnancy Exclusion
- Pregnant or breastfeeding.
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). Informed consent materials (Subject information and informed consent forms L1) are provided (documents listed for multiple countries and languages including English, Romanian, Hungarian, Bulgarian). No specific assent procedures for minors are described (minors are excluded by age criteria).
Inclusion criteria
- {"criterion_text":"- ≥18 and ≤65 years of age. Direct rollover participants must have been aged 18 to 65 (inclusive) at screening for the parent study."}
- {"criterion_text":"- Primary diagnosis of schizophrenia."}
Exclusion criteria
- {"criterion_text":"- Considered to be at imminent risk of suicide or injury to self or others."}
- {"criterion_text":"- Any unstable or poorly controlled medical condition or chronic disease"}
- {"criterion_text":"- Any laboratory test results indicating clinically significant, poorly managed, or unmanaged undiagnosed disease."}
- {"criterion_text":"- Certain heart conditions or uncontrolled blood pressure."}
- {"criterion_text":"- History of epilepsy, seizures (except seizures during childhood caused by a fever), or convulsions."}
- {"criterion_text":"- Currently taking medications that are not allowed."}
- {"criterion_text":"- Pregnant or breastfeeding."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Occurrence of AEs during the Open-Label Treatment Period","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 545
- Recruitment Window Months
- 74
- Consent Approach
- Informed consent obtained using subject information and informed consent forms (L1 documents). ICFs and related materials are available in multiple languages (English, Romanian, Hungarian, Bulgarian as indicated by document titles). Participants are adults (≥18 and ≤65); direct rollover participants must have been aged 18–65 at parent-study screening. No assent for minors is described because minors are excluded.
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 151
Hungary
- Earliest CTIS Part Ii Submission Date
- 07-11-2025
- Latest Decision Or Authorization Date
- 24-11-2025
- Processing Time Days
- 17
- Number Of Sites
- 2
- Number Of Participants
- 35
Sites
- Site Name
- Dr. Mathe Es Tarsa Bt.
- Department Name
- Psychiatry
- Contact Person Name
- Eva Mathe
- Contact Person Email
- matheevazs@gmail.com
- Site Name
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
- Department Name
- Psychiatry, Mentalhygiene and Addictology
- Contact Person Name
- Gabor Feller
- Contact Person Email
- fellerg@petz.gyor.hu
Romania
- Earliest CTIS Part Ii Submission Date
- 10-11-2025
- Latest Decision Or Authorization Date
- 21-11-2025
- Processing Time Days
- 11
- Number Of Sites
- 6
- Number Of Participants
- 52
Sites
- Site Name
- Spitalul Clinic De Psihiatrie Si Neurologie Brasov
- Department Name
- Psychiatry III Clinical Department
- Contact Person Name
- Petru-Iulian Ifteni
- Contact Person Email
- relatiicupublicul@spnbrasov.ro
- Site Name
- Institutul De Psihiatrie Socola Iasi
- Department Name
- Psychiatry II Clinical Department
- Contact Person Name
- Serban Turliuc
- Contact Person Email
- secretariat@socola.eu
- Site Name
- Centru De Evaluare Si Tratament A Toxicodependentelor Pentru Tineri Sf. Stelian
- Department Name
- Psychiatry Clinical Department
- Contact Person Name
- Traian-Liciniu Barbu
- Contact Person Email
- cettt_sf.stelian@yahoo.com
- Site Name
- Spitalul Clinic De Psihiatrie Si Neurologie Brasov
- Department Name
- Psychiatry II Clinical Department
- Contact Person Name
- Ana Aliana Miron
- Contact Person Email
- relatiicupublicul@spnbrasov.ro
- Site Name
- Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
- Department Name
- Psychiatry I Clinical Department
- Contact Person Name
- Ana Anca Chendea
- Contact Person Email
- secretariat@spital-obregia
- Site Name
- Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
- Department Name
- Psychiatry IX Clinical Department
- Contact Person Name
- Adela Magdalena Ciobanu
- Contact Person Email
- secretariat@spital-obregia
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 17-10-2025
- Latest Decision Or Authorization Date
- 30-01-2026
- Processing Time Days
- 105
- Number Of Sites
- 4
- Number Of Participants
- 64
Sites
- Site Name
- University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
- Department Name
- First Psychiatric Clinic - Psychiatry
- Contact Person Name
- Maya Popova
- Contact Person Email
- dr.maya.stoimenova@gmail.com
- Site Name
- Center For Mental Health Vratsa EOOD
- Department Name
- Department of General Psychiatry
- Contact Person Name
- Nadya Ivanova
- Contact Person Email
- nadia_odpzs@abv.bg
- Site Name
- State Psychiatric Hospital Tserova Koria
- Department Name
- Department for Active Treatment of Severe Psychosis – males/females
- Contact Person Name
- Stoyan Zdravkov
- Contact Person Email
- szdravkov@gmail.com
- Site Name
- MBAL Dr. Ivan Seliminski - Sliven AD
- Department Name
- Psychiatry
- Contact Person Name
- Rozalina Petrova
- Contact Person Email
- dr.rozalina.petrova@gmail.com
Sponsor
Primary sponsor
- Full Name
- Neurocrine Biosciences Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Premier Research International LLC
- Name
- Cronos Clinical Consulting Services, Inc.
- Responsibilities
- Rater training/ Scales management
- Name
- Suvoda LLC
- Responsibilities
- Interactive response technologies (IRT)
- Name
- Verified Clinical Trials LLC
- Responsibilities
- Determine if the potential patients have/are participated/participating in another trial
- Name
- Scout Clinical
- Responsibilities
- Subject expenses reimbursement
- Name
- LabConnect GmbH
- Name
- Arup Laboratories Inc.
- Responsibilities
- Genotyping
- Name
- Dr. Wisplinghoff Laboratory
- Responsibilities
- General Lab
- Name
- Etymax Limited
- Responsibilities
- Translations of study documents
Third parties
- {"country":"United Kingdom","full_name":"Etymax Limited","duties_or_roles":"Translations of study documents","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Dr. Wisplinghoff Laboratory","duties_or_roles":"General Lab","organisation_type":"Industry"}
- {"country":"Germany","full_name":"LabConnect GmbH","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Verified Clinical Trials LLC","duties_or_roles":"Determine if the potential patients have/are participated/participating in another trial","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Subject expenses reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"Interactive response technologies (IRT)","organisation_type":"Industry"}
- {"country":"United States","full_name":"Arup Laboratories Inc.","duties_or_roles":"Genotyping","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Premier Research International LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cronos Clinical Consulting Services, Inc.","duties_or_roles":"Rater training/ Scales management","organisation_type":"Industry"}
Investigational products
- Investigational Product Name
- NBI-1117568
- Active Substance
- DIRECLIDINE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Investigational Product Name
- NBI-1117568
- Active Substance
- DIRECLIDINE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
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