Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy
Condition: Partial Epilepsy
MeSH terms: Epilepsy; Epilepsies, Partial
Intervention: Lacosamide; Placebo
Intervention description: Subjects randomized to lacosamide according to the following schedule:
Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid; Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
Intervention MeSH terms: Lacosamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Partial epilepsy; Excessive daytime sleepiness; Epworth Sleepiness Scale; Maintenance of Wakefulness Test

Summary:

      Sleepiness and fatigue are the most common complaints of people with epilepsy and can have a
      negative impact on quality of life. Though unproven, these problems are often blamed on
      anti-seizure medications. The purpose of this study is to investigate the impact of the
      anti-seizure medication Lacosamide (Vimpat®) on sleep and wakefulness in adults with focal
      (partial onset) seizures.

      Focal epilepsy, also called partial epilepsy, is a disorder characterized by seizures arising
      from a localized network of neurons in the brain. Focal seizures usually begin a sensation or
      involuntary movement of a part of the body, an unusual feeling, or a disturbance in hearing,
      smell, vision, or consciousness. The study is open to adults 18 and older with focal
      seizures.

      Participation involves a physical exam, sleep testing at the Sleep Center, blood tests,
      completion of study questionnaires/diaries, and a random assignment to either take the study
      drug or placebo (often called a "look alike" or "sugar pill") for 5 to 8 weeks. There are 5
      study visits. Participants will receive compensation for time spent in the study.

      If you would like more information on this study please contact the Cleveland Clinic Sleep
      Center:

      Dr. Nancy Foldvary-Schaefer: 216-445-2990 Monica Bruton: 216-444-6718
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must meet the following inclusion criteria to be eligible for the study.

          -  Subject can provide written informed consent and is willing to comply with study
             procedures.

          -  Subject is at least 18 years of age.

          -  Subject has focal epilepsy with classifiable seizures according to the International
             Classification of Epileptic Seizures, 1981.11

          -  Subject is deemed to be an appropriate candidate for LCM adjunctive therapy.

          -  Subject has been maintained on a stable dose of 1 or 2 marketed AEDs for at least 4
             weeks.

        Exclusion Criteria:

        Subjects must meet the following exclusion criteria to be eligible for the study.

          -  Subject has a history of a moderate or severe sleep apnea (apnea-hypopnea index [AHI]
             > 15), severe insomnia (habitual sleep duration < 4 hours) or narcolepsy.

          -  Subject has a score on the Sleep Apnea Scale of the Sleep Disorders Questionnaire
             (SA/SDQ) at screening of 32 or higher (female) and 36 or higher (male).

          -  Subject is currently participating or has participated within the last 2 months in a
             trial of an investigational drug or experimental device.

          -  Subject has seizures or seizures clusters that are not quantifiable.

          -  Subject has 6 or more seizures (excluding auras) in the 2-week Baseline Phase.

          -  Subject has a medical condition that could reasonably be expected to interfere with
             drug absorption, distribution, metabolism or excretion.

          -  Subject has any medical or psychiatric condition, which in the opinion of the
             investigator, could jeopardize the subject's health or would compromise the - Subject
             has a history of alcohol or drug abuse within the previous 2 years.

          -  Subject has an acute or sub-acutely progressive central nervous system disease.

          -  Subject is pregnant, breastfeeding or of childbearing age and not surgically sterile
             or practicing an acceptable form of contraception (barrier contraception, surgically
             sterilized, IUD, abstinence) for the duration of the trial.