Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT05081518
Status:
TERMINATED
Last Update Posted:
2022-11-09
First Post:
2021-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Lu AG06466 in Participants With Treatment Resistant Focal Epilepsy
Sponsor:
H. Lundbeck A/S
Organization:
Study Overview
Official Title:
Interventional, Randomized, Double-blind, Crossover, Placebo-controlled, Multiple-dose Lu AG06466 Phase 1 B Study in Patients With Focal Epilepsy Using EEG and PSG to Investigate Its Pharmacodynamic Effects on Prolonged Period of Inter- Icterical Spikes, Sleep and Neuroinflammation
Status:
TERMINATED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated due to enrolment challenges
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to investigate effects of Lu AG06466 on seizure activity after increasing daily doses during 4 weeks in participants with an implanted responsive neurostimulation system.
Detailed Description:
This crossover study consists of 2 treatment periods, each of 29 days duration. On Day -1 of treatment period 1, eligible participants will be randomized (1:1) to a sequence of treatments (either Lu AG06466-placebo or placebo-Lu AG06466).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: