Clinical trial • Phase II • Psychiatry
LY03010 for Schizophrenia
Phase II trial of LY03010 for Schizophrenia.
Overview
- Trial Therapeutic Area
- Psychiatry
- Trial Disease
- Schizophrenia
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 24-11-2023
- First CTIS Authorization Date
- 04-04-2024
Trial design
Randomised, open-label, ly03010 versus xeplion®; dose and schedule not specified in the available record-controlled Phase II trial in Bulgaria, Portugal, Croatia.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- LY03010 versus XEPLION®; dose and schedule not specified in the available record
- Target Sample Size
- 158
Recruitment
- Planned Sample Size
- 158
- Recruitment Window Months
- 16
Geography
- Total Number Of Sites
- 19
- Total Number Of Participants
- 170
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 28-03-2024
- Latest Decision Or Authorization Date
- 08-04-2024
- Processing Time Days
- 11
- Number Of Sites
- 12
- Number Of Participants
- 85
Sites
- Site Name
- Center For Mental Health Vratsa EOOD
- Department Name
- psychiatry
- Contact Person Name
- Nadya Ivanova
- Contact Person Email
- nadia_odpzs@abv.bg
- Site Name
- MENTAL HEALTH CENTER PROF. DR. IVAN TEMKOV
- Department Name
- psychiatry
- Contact Person Name
- Veselin Palazov
- Contact Person Email
- vPalazov@abv.bg
- Site Name
- "Multiprofile Hospital for Active Treatment Dr. Hristo Stambolski"
- Department Name
- psychiatry
- Contact Person Name
- Ivan Todorov Dimitrov
- Contact Person Email
- itdim@abv.bg
- Site Name
- Outpatient Clinic For Specialized Medical Care-Individual Practice For Specialized Medical Care-Psychiatry Dr. Georgi Hranov
- Department Name
- psychiatry
- Contact Person Name
- Georgi Hranov
- Contact Person Email
- hranov@gmail.com
- Site Name
- Center For Skin And Venereal Diseases Veliko Tarnovo EOOD
- Department Name
- psychiatry
- Contact Person Name
- Nikitov Ognyan Nikolaev
- Contact Person Email
- o.nikitov@gmail.com
- Site Name
- Diagnostics-Consultancy Center Mladost M Varna OOD
- Department Name
- psychiatry
- Contact Person Name
- Hristo Vasilev Kozhuharov
- Contact Person Email
- christokojuharov@abv.bg
- Site Name
- University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
- Department Name
- psychiatry
- Contact Person Name
- Maya Yordanova Stoimenova-Popova
- Contact Person Email
- dr.maya.stoimenova@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
- Site Name
- Higya–DCC OOD
- Department Name
- psychiatry
- Contact Person Name
- Dora Atanasova
- Contact Person Email
- dora_pazardjik@abv.bg
- Site Name
- Multiprofile Hospital For Active Treatment - Targovishte AD
- Department Name
- psychiatry
- Contact Person Name
- Veselka Vasileva
- Contact Person Email
- vesi_vasileva2002@yahoo.com
- Site Name
- State Psychiatric Hospital Tsarev Brod
- Department Name
- psychiatry
- Contact Person Name
- Neli Todorova
- Contact Person Email
- nelly_nik@abv.bg
- Site Name
- Alexandrovska University Hospital
- Department Name
- psychiatry
- Contact Person Name
- Vihra Milanova
- Contact Person Email
- vihra.milanova@gmail.com
Portugal
- Earliest CTIS Part Ii Submission Date
- 07-02-2024
- Latest Decision Or Authorization Date
- 05-04-2024
- Processing Time Days
- 58
- Number Of Sites
- 4
- Number Of Participants
- 56
Sites
- Site Name
- Centro Hospitalar De Vila Nova De Gaia/Espinho E.P.E.
- Department Name
- Psychiatry and Mental Health Service
- Contact Person Name
- Georgina Lapa
- Contact Person Email
- glapa@chvng.min-saude.pt
- Site Name
- CCAB Centro Clinico Academico Braga Associacao
- Department Name
- Psychiatry Service
- Contact Person Name
- Pedro Morgado
- Contact Person Email
- pedromorgado@med.uminho.pt
- Site Name
- Hospitais Senhor Do Bonfim S.A.
- Department Name
- Neurosciences
- Contact Person Name
- Jacinto Azevedo
- Contact Person Email
- jacinto.azevedo@trofasaude.com
- Site Name
- Centro Hospitalar De Leiria E.P.E.
- Department Name
- Psychiatry
- Contact Person Name
- Ana Fonseca
- Contact Person Email
- ana.fonseca@chleiria.min-saude.pt
Croatia
- Earliest CTIS Part Ii Submission Date
- 28-03-2024
- Latest Decision Or Authorization Date
- 27-08-2024
- Processing Time Days
- 152
- Number Of Sites
- 3
- Number Of Participants
- 29
Sites
- Site Name
- Clinic for psychiatry Sveti Ivan
- Department Name
- psychiatry
- Contact Person Name
- Igor Filipcic
- Contact Person Email
- igor.filipcic@pbsvi.hr
- Site Name
- KBC Split
- Department Name
- psychiatry
- Contact Person Name
- Trpimir Glavina
- Contact Person Email
- office@kbsplit.hr
- Site Name
- Klinika za psihijatriju Vrapce
- Department Name
- psychiatry
- Contact Person Name
- Miroslav Herceg
- Contact Person Email
- miroslav.herceg@bolnica-vrapce.hr
Sponsor
Primary sponsor
- Full Name
- Geneora Pharma (Shijiazhuang) Co. Ltd.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- China
Investigational products
- Investigational Product Name
- LY03010
- Modality
- Small molecule
- Investigational Product Name
- XEPLION®
- Modality
- Small molecule
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