Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
144
Countries
4
Sites
5
Schizophrenia
Key facts
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 19 Jun 2024 → 4 Sep 2025
- Decision date (initial)
- 2024-05-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-505664-11-00
- ClinicalTrials.gov
- NCT06315283
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Schizophrenia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10039626 | Schizophrenia | 100000004873 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Teva Branded Pharmaceutical Products R&D LLC
- Sponsor organisation
- Teva Branded Pharmaceutical Products R&D LLC
- Address
- 145 Brandywine Parkway
- City
- West Chester
- Postcode
- 19380-4245
- Country
- United States
Scientific contact point
- Organisation
- Teva Branded Pharmaceutical Products R&D LLC
- Contact name
- Medical Information
Public contact point
- Organisation
- Teva Branded Pharmaceutical Products R&D LLC
- Contact name
- Medical Information
Locations
4 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Croatia | Ended | 9 | 1 |
| France | Not authorised | 3 | 2 |
| Germany | Ended | 2 | 1 |
| Spain | Ended | 4 | 1 |
| Rest of world
United Kingdom, United States
|
— | 126 | — |
Investigational sites
Clinic for psychiatry Sveti Ivan
N/A, Jankomir 11, Zagreb, Grad Zagreb
Centre Hospitalier Universitaire De Montpellier
Service de Psychiatrie Adulte, Pavillon 32, 39 Avenue Charles Flahault, Montpellier Cedex 5
CHU Gabriel-Montpied
Service de Psychiatrie Adulte, 58 Rue Montalembert, 63000, Clermont Ferrand
Goethe University Frankfurt
Klinik für Psychiatrie, Psychosomatik und Psychotherapie, Heinrich-Hoffmann-Strasse 10, Niederrad, Frankfurt Am Main
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 |
|---|---|---|---|---|---|
| Croatia | 2024-06-19 | 2025-05-13 | 2024-09-03 | 2025-04-23 | |
| Spain | 2024-07-05 | 2025-08-11 | 2024-10-29 | 2025-04-23 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-17 | Spain | Acceptable 2024-05-07
|
2024-05-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-13 | Spain | 2024-09-30 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-10 | Spain | Acceptable 2025-04-14
|
2025-04-14 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-23 | Spain | Acceptable 2025-04-14
|
2025-04-23 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-02 | Spain | Acceptable 2025-07-28
|
2025-08-04 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-08-27 | Spain | Acceptable 2025-07-28
|
2025-08-27 |