Clinical trial • Phase III • Neurology

NBI-921355 for Epilepsy

Phase III trial of NBI-921355 for Epilepsy. 24 participants.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Epilepsy
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
16-03-2026
First CTIS Authorization Date
29-04-2026

Trial design

Phase III trial across 1 site in Netherlands.

Target Sample Size
24

Eligibility

Recruits 24 No vulnerable populations selected; trial population: Healthy volunteers. Consent/assent handling not specified in available documents..

Vulnerable Population
No vulnerable populations selected; trial population: Healthy volunteers. Consent/assent handling not specified in available documents.

Recruitment

Planned Sample Size
24
Recruitment Window Months
4
Consent Approach
Informed consent process not specified in available documents.

Geography

Total Number Of Sites
1
Total Number Of Participants
24

Netherlands

Earliest CTIS Part Ii Submission Date
28-04-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
6
Number Of Sites
1
Number Of Participants
24

Sites

Site Name
Centre for Human Drug Research
Department Name
Neurology
Contact Person Name
Philip Kremer
Contact Person Email
clintrials@chdr.nl
Number Of Participants
24

Sponsor

Primary sponsor

Full Name
Neurocrine Biosciences Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
NBI-921355

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