Open-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy

Phase 2

Completed

• Conditions: Epilepsy
• Interventions: Drug: Lacosamide

• Registration Number: NCT01118949
• Lead Sponsor: UCB BIOSCIENCES, Inc.

Brief Summary

The purpose is to assess the safety of Lacosamide in subjects with uncontrolled Primary Generalized Tonic-Clonic (PGTC) seizures with Idiopathic Generalized Epilepsy.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-05
• Study First Submitted QC: 2010-05-06
• Study First Posted: 2010-05-07
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Results First Submitted: 2012-08-08
• Results First Submitted QC: 2012-08-08
• Results First Posted: 2012-09-07
• Status Verified: 2018-03
• Last Update Submitted: 2018-06-20
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Subject has a diagnosis of uncontrolled epilepsy with primary generalized tonic-clonic (PGTC) seizures and idiopathic generalized epilepsy. Diagnosis should have been established by an electroencephalogram (EEG) with generalized spike-wave discharges within 5 years of the screening visit
• Subject has ≥1 PGTC seizure within the 12 weeks prior to the screening visit
• Subject has a stable dose regimen of 1 to 3 marketed antiepileptic drug(s) (AEDs) with or without additional concurrent stable Vagus Nerve Stimulation (VNS). The VNS must have been in place for at least 6 months prior to study entry with constant settings for at least 28 days prior to the screening visit and during the Baseline Phase. Benzodiazepines will be counted as an AED

Exclusion Criteria

• Subject has a history of partial-onset seizures or EEG findings consistent with partial onset seizures
• Subject has a history of status epilepticus within the 5-year Period prior to Visit 1
• Subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or other non-epileptic ictal events
• Subject has any medical or psychiatric condition
• Subject has any history of alcohol or drug abuse
• Subject is currently taking felbamate
• Subject has ever taken vigabatrin and has no visual fields examination report available or if results of the examination are abnormal
• Subject is on a ketogenic diet
• Subject has a known sodium channelopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lacosamide	Lacosamide	-

Primary Outcome Measures

Name	Time	Method
Change in the Number of Seizure Days With Absence Seizures From the Baseline Phase to the Maintenance Phase	From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)	During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded: * Seizure type; * Seizure frequency; A negative value in change of seizure days with absence seizures shows a decrease in seizure days with absence seizures.
Change in the Number of Seizure Days With Myoclonic Seizures From the Baseline Phase to the Maintenance Phase	From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)	During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded: * Seizure type; * Seizure frequency; A negative value in change of seizure days with myoclonic seizures shows a decrease in seizure days with myoclonic seizures.

Secondary Outcome Measures

Name	Time	Method
Changes in Count of Generalized Spike-wave Discharges on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)	From Visit 2 (Week 4) to Visit 6 (Week 8)	Subjects were asked to return to the clinic on the morning of the day prior to Visit 2 and Visit 6 to begin 24-hour ambulatory EEG recordings for evaluation of spike-wave discharges. Only subjects with an evaluable EEG measurement with \> 19 interpretable hours at Visit 2 and Visit 6 are included in this analysis. The general spike-wave discharges are calculated per interpretable hours.
Changes in Count of 3 Hertz (Hz) Spike-wave Discharges (During Waking Hours) on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)	From Visit 2 (Week 4) to Visit 6 (Week 8)	Subjects were asked to return to the clinic on the morning of the day prior to Visit 2 and Visit 6 to begin 24-hour ambulatory EEG recordings for evaluation of spike-wave discharges. Only subjects with an evaluable EEG measurement with \> 19 interpretable hours at Visit 2 and Visit 6 are included in this analysis. The 3 Hertz (Hz) spike-wave discharges are calculated per awake hours.
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period	From Visit 2 (Week 4) to Visit 7 (Week 13)	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Number of Subjects Withdrawn From the Study Due to Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period	From Visit 2 (Week 4) to Visit 7 (Week 13)	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.