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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

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)

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

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 • NCT01235403

42%

Dizziness

Headache

Asthenia

Status epilepticus

Gait disturbance

Partial seizures with secondary generalisation

Diplopia

Nausea

Coma

100%

80%

60%

40%

20%

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

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