Overview

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
Phase:
Phase 4
Details
Lead Sponsor:
The Cleveland Clinic
Collaborator:
UCB Pharma
Treatments:
Lacosamide