Open-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Lacosamide
Intervention description: Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
Intervention MeSH terms: Lacosamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Primary Generalized Tonic-Clonic (PGTC) Seizures; Absence Seizures; Myoclonic Seizures; Idiopathic Generalized Epilepsy (IGE)

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