Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
96
Countries
1
Sites
2
Idiopathic intracranial hypertension
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2026-04-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Idiopathic intracranial hypertension
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Valdemar Hansens Vej 1-23
- City
- Glostrup
- Postcode
- 2600
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Frederik Peter Thal Jantzen
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Frederik Peter Thal Jantzen
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 96 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-10 | Denmark | Acceptable 2026-03-31
|
2026-04-13 |