Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
5
Countries
2
Sites
3
Multiple Sclerosis (MS)
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 25 Jul 2023 → 29 Jan 2026
- Decision date (initial)
- 2024-07-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506863-32-00
- EudraCT number
- 2022-001209-33
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Multiple Sclerosis (MS)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10028245 | Multiple sclerosis | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Croatia | Ended | 2 | 2 |
| Czechia | Ended | 3 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Klinicki bolnicki centar Sestre milosrdnice
Neurology, Vinogradska Cesta 29, Zagreb, Grad Zagreb
KBC Zagreb
Neurology, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
Fakultni Nemocnice Hradec Kralove
Neurologie - RS centrum, Sokolska 581, 500 03, Novy Hradec Kralove
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 | 2023-07-25 | 2026-01-19 | 2023-08-07 | 2024-03-25 | |
| Czechia | 2023-08-25 | 2026-01-28 | 2023-09-18 | 2024-03-25 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-11 | Czechia | Acceptable with conditions 2024-07-10
|
2024-07-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-21 | Czechia | Acceptable with conditions 2024-07-10
|
2024-08-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-24 | Czechia | Acceptable 2024-11-21
|
2024-11-26 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-01-30 | Acceptable 2024-11-21
|
2025-01-30 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-17 | Czechia | Acceptable 2025-04-16
|
2025-04-16 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-12 | Czechia | Acceptable 2025-08-29
|
2025-08-29 |