Clinical trial • Phase III • Neurology

Lu AH69593 for Narcolepsy | Cataplexy

Phase III trial of Lu AH69593 for Narcolepsy | Cataplexy. 104 participants.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Narcolepsy | Cataplexy
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
13-02-2025
First CTIS Authorization Date
27-05-2025

Trial design

Phase III trial across 2 sites in Finland.

Target Sample Size
104

Eligibility

Recruits 104 No vulnerable populations selected; participants are adults; consent to be provided by the adult participants; assent not applicable..

Vulnerable Population
No vulnerable populations selected; participants are adults; consent to be provided by the adult participants; assent not applicable.

Recruitment

Planned Sample Size
104
Recruitment Window Months
18
Consent Approach
Not specified; participants are adults; consent provided by participants; assent not applicable.

Geography

Total Number Of Sites
2
Total Number Of Participants
104

Finland

Earliest CTIS Part Ii Submission Date
02-05-2025
Latest Decision Or Authorization Date
19-02-2026
Processing Time Days
293
Number Of Sites
2
Number Of Participants
104

Sites

Site Name
Suomen Terveystalo Oy
Department Name
Terveystalo Sleep Clinic
Contact Person Name
Gabriele Sved
Contact Person Email
Gabriele.Sved@terveystalo.com
Site Name
Clinical Research Services Turku CRST Oy
Department Name
CRST Turku
Contact Person Name
Petri Vainio
Contact Person Email
petri.vainio@crst.fi

Sponsor

Primary sponsor

Full Name
H. Lundbeck A/S
Organisation Type
Pharmaceutical company
Country Of Registered Address
Denmark

Investigational products

Investigational Product Name
Lu AH69593

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