Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
36
Countries
1
Sites
1
Glioblastoma
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10], Phenomena and Processes [G] - Genetic Phenomena [G05], Diseases [C] - Neoplasms [C04]
- Trial duration
- 1 Mar 2026 → ongoing
- Decision date (initial)
- 2025-10-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Glioblastoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10018336 | Glioblastoma | 100000004864 |
| 21.1 | PT | 10065443 | Malignant glioma | 100000004864 |
| 20.0 | PT | 10018337 | Glioblastoma multiforme | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- Anders Rosendal Korshøj, MD, PhD Consultant, Associate Professor, Department of Neurosurgery
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Henriette Thygesen, Research Secretary, Department of Neurosurgery
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 36 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Denmark | 2026-03-01 | 2026-03-27 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-09 | Denmark | Acceptable 2025-10-10
|
2025-10-14 |