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A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures
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
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing a seizure medication called lacosamide in children. The goal is to see if it is safe and works well over time. Lacosamide helps by calming down the brain's overactive electrical signals that cause seizures.
Eligible Conditions
- Epilepsy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from week 0 to the end of safety follow-up (up to week 104)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 0 to the end of safety follow-up (up to week 104)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Percentage of Seizure-free Days During the Study
Side effects data
From 2011 Phase 4 trial • 100 Patients • NCT0123540342%
Dizziness
8%
Headache
5%
Asthenia
1%
Status epilepticus
1%
Gait disturbance
1%
Partial seizures with secondary generalisation
1%
Diplopia
1%
Nausea
1%
Coma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lacosamide
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
115 Previous Clinical Trials
22,659 Total Patients Enrolled
14 Trials studying Epilepsy
1,930 Patients Enrolled for Epilepsy
UCB BIOSCIENCES, Inc.Lead Sponsor
27 Previous Clinical Trials
6,682 Total Patients Enrolled
13 Trials studying Epilepsy
3,016 Patients Enrolled for Epilepsy
UCB CaresStudy Director001 844 599 2273 (UCB)
219 Previous Clinical Trials
46,033 Total Patients Enrolled
50 Trials studying Epilepsy
11,325 Patients Enrolled for Epilepsy