Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
30
Countries
1
Sites
1
This is a study in healthy volunteers. We will study the trigeminovascular system, which is relevant in the pathophysiology of migraine.
Key facts
- Sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Phenomena and Processes [G] - Physiological processes [G07], Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Hormonal diseases [C19], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
- Decision date (initial)
- 2025-07-02
- 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
This is a study in healthy volunteers. We will study the trigeminovascular system, which is relevant in the pathophysiology of migraine.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10060890 | Trigeminal nerve disorder | 100000004852 |
| 20.0 | HLT | 10027603 | Migraine headaches | 10029205 |
| 21.0 | PT | 10075009 | Laser speckle contrast imaging | 100000004848 |
| 20.0 | LLT | 10065540 | Menstrual migraine | 10029205 |
| 20.0 | LLT | 10044649 | Trigeminal nerve disorders | 10029205 |
| 20.0 | PT | 10027599 | Migraine | 100000004852 |
| 20.0 | PT | 10033329 | Oxytocin | 100000004848 |
| 21.1 | LLT | 10066635 | Acute migraine | 10029205 |
| 20.0 | LLT | 10027602 | Migraine headache | 10029205 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Sponsor organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Address
- Dr. Molewaterplein 40
- City
- Rotterdam
- Postcode
- 3015 GD
- Country
- Netherlands
Scientific contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Department of Internal Medicine, Division of Pharmacology and Vascular Medicine
Public contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Department of Internal Medicine, Division of Pharmacology and Vascular Medicine
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Internal Medicine, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-17 | Netherlands | Acceptable with conditions 2025-07-02
|
2025-07-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-30 | Netherlands | Acceptable 2025-10-22
|
2025-10-22 |