Phase 2
N=49
Open-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT01118949 ↗Enrolled (actual)
49
Serious AEs
2.0%
Results posted
Sep 2012
Primary outcome: Primary: Change in the Number of Seizure Days With Absence Seizures From the Baseline Phase to the Maintenance Phase — -0.37 number of seizure days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lacosamide (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- UCB BIOSCIENCES, Inc.
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Number of Seizure Days With Absence Seizures From the Baseline Phase to the Maintenance Phase |
-0.37 | — |
| PRIMARY Change in the Number of Seizure Days With Myoclonic Seizures From the Baseline Phase to the Maintenance Phase |
-2.19 | — |
| SECONDARY Changes in Count of Generalized Spike-wave Discharges on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase) |
-3.47 | — |
| SECONDARY 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) |
0.13 | — |
| SECONDARY Number of Subjects With Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period |
43 | — |
| SECONDARY Number of Subjects Withdrawn From the Study Due to Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period |
5 | — |
Summary
The purpose is to assess the safety of Lacosamide in subjects with uncontrolled Primary Generalized Tonic-Clonic (PGTC) seizures with Idiopathic Generalized Epilepsy.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01118949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.