NCT05081518

A Study of Lu AG06466 in Participants With Treatment Resistant Focal Epilepsy

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Focal Epilepsy

Interventions

Type	Name	Description
DRUG	Lu AG06466	Lu AG06466 - capsule
DRUG	Placebo	Placebo - capsule

Timeline

• Start date: 2021-09-29
• Primary completion: 2022-04-14
• Completion: 2022-04-14
• First posted: 2021-10-18
• Last updated: 2022-11-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study