Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
104
Countries
1
Sites
1
Narcolepsy
Key facts
- Sponsor
- H. Lundbeck A/S
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 19 Feb 2026 → ongoing
- Decision date (initial)
- 2026-02-09
- 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
Narcolepsy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10007738 | Cataplexy and narcolepsy | 10029205 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
H. Lundbeck A/S
- Sponsor organisation
- H. Lundbeck A/S
- Address
- Ottiliavej 9
- City
- Valby
- Postcode
- 2500
- Country
- Denmark
Scientific contact point
- Organisation
- H. Lundbeck A/S
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- H. Lundbeck A/S
- Contact name
- Clinical Trial Information
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 104 | 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 |
|---|---|---|---|---|---|
| France | 2026-02-19 | 2026-02-19 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-15 | France | Acceptable 2026-02-09
|
2026-02-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-27 | France | Acceptable 2026-05-05
|
2026-05-05 |