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Lu AG06466 for Epilepsy

Phase 1
Waitlist Available
Research Sponsored by H. Lundbeck A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day -1) up to day 29 of each treatment period
Awards & highlights

Study Summary

This study is evaluating whether a drug can reduce seizure activity in people with epilepsy.

Eligible Conditions
  • Epilepsy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day -1) up to day 29 of each treatment period
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day -1) up to day 29 of each treatment period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of "Long Episodes" (Electrocorticographic [ECoG] Seizures)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sequence 2: Placebo-Lu AG06466Experimental Treatment2 Interventions
Participants will receive matching placebo capsules QD from Day 1 to Day 29 in treatment period 1. Participants will receive Lu AG06466 capsules QD at a low dose for 4 days (Days 1 to 4), medium dose for 4 days (Days 5 to 8), and high dose for 21 days (Days 9 to 29) in treatment period 2. Each treatment period will be separated by a washout period of 7 to 11 days.
Group II: Sequence 1: Lu AG06466-PlaceboExperimental Treatment2 Interventions
Participants will receive Lu AG06466 capsules once daily (QD) at a low dose for 4 days (Days 1 to 4), medium dose for 4 days (Days 5 to 8), and high dose for 21 days (Days 9 to 29) in treatment period 1. Participants will receive matching placebo capsules from Day 1 to Day 29 in treatment period 2. Each treatment period will be separated by a washout period of 7 to 11 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lu AG06466
2020
Completed Phase 1
~90
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

H. Lundbeck A/SLead Sponsor
325 Previous Clinical Trials
77,582 Total Patients Enrolled
3 Trials studying Epilepsy
241 Patients Enrolled for Epilepsy
Email contact via H. Lundbeck A/SStudy DirectorLundbeckClinicalTrials@Lundbeck.com
188 Previous Clinical Trials
58,339 Total Patients Enrolled
4 Trials studying Epilepsy
512 Patients Enrolled for Epilepsy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of Lu AG06466 in Participants With Treatment Resistant Focal Epilepsy
2021. "A Study of Lu AG06466 in Participants With Treatment Resistant Focal Epilepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05081518.
~0 spots leftby May 2025
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