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Lacosamide for Epilepsy

Phase 3
Waitlist Available
Research Sponsored by UCB BIOSCIENCES, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 0 to the end of safety follow-up (up to week 104)
Awards & highlights

Study Summary

This study is evaluating whether lacosamide is safe and effective for treating epilepsy in children.

Eligible Conditions
  • Epilepsy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 0 to the end of safety follow-up (up to week 104)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 0 to the end of safety follow-up (up to week 104) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Serious TEAEs
Percentage of Participants With TEAEs Leading to Study Discontinuation
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Secondary outcome measures
Percentage of Seizure-free Days During the Study

Side effects data

From 2011 Phase 4 trial • 100 Patients • NCT01235403
42%
Dizziness
8%
Headache
5%
Asthenia
1%
Status epilepticus
1%
Partial seizures with secondary generalisation
1%
Gait disturbance
1%
Diplopia
1%
Nausea
1%
Coma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lacosamide

Trial Design

1Treatment groups
Experimental Treatment
Group I: LacosamideExperimental Treatment1 Intervention
In the first week after enrollment into EP0034 subjects will be dosed according to their weight: Lacosamide (LCM) 10 mg/kg/day (oral solution) for subjects weighing <30 kg LCM 6 mg/kg/day (oral solution) for subjects weighing ≥30 kg to <50 kg LCM 300 mg/day (tablets) for subjects weighing ≥50 kg After 1 week the investigator may adjust the LCM dose during the Treatment Period based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lacosamide
2008
Completed Phase 4
~4360

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLIndustry Sponsor
104 Previous Clinical Trials
21,274 Total Patients Enrolled
14 Trials studying Epilepsy
1,930 Patients Enrolled for Epilepsy
UCB BIOSCIENCES, Inc.Lead Sponsor
25 Previous Clinical Trials
6,660 Total Patients Enrolled
13 Trials studying Epilepsy
3,016 Patients Enrolled for Epilepsy
UCB CaresStudy Director001 844 599 2273 (UCB)
207 Previous Clinical Trials
44,634 Total Patients Enrolled
49 Trials studying Epilepsy
11,314 Patients Enrolled for Epilepsy
~50 spots leftby Jun 2025
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