A Trial to Evaluate the Long Term Safety and Tolerability of Lacosamide Taken as Monotherapy in Adults With Partial-onset Seizures
Condition: Epilepsy; Partial-onset Seizures
MeSH terms: Epilepsy; Seizures
Intervention: Lacosamide
Intervention description: Lacosamide (LCM) immediate-release, film-coated tablets at a strength of 50 mg orally administered twice daily in two equally divided doses.
4-week Titration Period: Starting on LCM 100 mg/day increased by 100 mg/day each week until 400 mg/day dose reached at the beginning of Week 4 .
The AED Withdrawal Period and Monotherapy Period (52- week Evaluation Period plus a Follow Up Period): During the AED Withdrawal and Monotherapy Period, the investigator may increase or decrease the dose of LCM to optimize tolerability and seizure control. The LCM dose may be decreased no lower than 200 mg/day or increased, no faster than 100 mg/day per week, up to 600 mg/day.
Intervention MeSH terms: Lacosamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Lacosamide; Epilepsy; Focal, Partial-Onset Seizures with or without secondary generalization; Monotherapy

Summary:

      This study is to evaluate the long-term safety and tolerability of Lacosamide (LCM) 200
      mg/day to LCM 600 mg/day taken in monotherapy in Japanese subjects who currently have
      partial-onset seizures with or without secondary generalization and who are treated with a
      single Anti-Epileptic Drug (AED) with marketing approval in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is male or female and ≥16 years of age

          -  Subject has a diagnosis of epilepsy, having experienced unprovoked partial-onset
             seizures (IA, IB, or IC with clear focal origin) that are classifiable according to
             the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures,
             1981

          -  Subject experiences partial-onset seizures despite appropriately chosen and adequately
             tried treatment with 1 antiepileptic drug (AED)

          -  Subject has been treated for epilepsy with a stable dose of 1 marketed AED The use of
             benzodiazepines is permitted as rescue therapy for epilepsy. Benzodiazepines may have
             been used as needed but not more frequently than once per week.

        Exclusion Criteria:

          -  Subject has a history or presence of seizures of other types than partial onset (IA,
             IB, or IC with clear focal origin)

          -  Subject is taking benzodiazepines for a nonepilepsy indication (Exception: Concomitant
             use of benzodiazepines is allowed if the subject is taking them on a regular basis,
             has been on a stable dose for at least 1 month prior to Visit 1, and does not require
             changes in the dosage and administration throughout the study period. However,
             concomitant use of benzodiazepines on an as needed basis is not permitted.)

          -  Female subject who is pregnant or nursing, and/or a woman of childbearing potential
             who is not surgically sterile, 2 years postmenopausal or does not practice 1 highly
             effective method of contraception, unless sexually abstinent, for the duration of the
             study

          -  Female subject of childbearing potential taking enzyme-inducing antiepileptic drugs
             (EI-AEDs: CBZ, phenytoin, barbiturates, primidone, topiramate) who is not surgically
             sterile, 2 years postmenopausal or does not practice 1 highly effective method of
             contraception according to the World Health Organization (WHO) recommendation (ie,
             depot medroxyprogesterone acetate, norethisterone enantate, intrauterine devices,
             combined injectables, and progestogen implants) with administration of EI-AEDs or does
             not practice 2 combined methods of contraception (ie, combined hormonal contraception
             plus barrier method with spermicidal agent), unless sexually abstinent, for the
             duration of the study

          -  Subject has sick sinus syndrome without a pacemaker, or a second or third degree
             atrioventricular (AV) block, or subject has any other clinically relevant
             electrocardiogram (ECG) abnormalities

          -  Subject has a history of convulsive status epilepticus within the last 12 months prior
             to Visit 1