Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy
Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
Participant gender:
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 (VimpatĀ®) 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