Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Searching for "Sleep Friendly" Therapies for a Sleepy Population: A Double-Blind, Placebo-Controlled, Randomized Trial to Assess the Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy|
- Change in Epworth Sleepiness Scale score from Baseline to Visit 4 [ Time Frame: Baseline, Visit 3, 4 and 6 ] [ Designated as safety issue: Yes ]
- Change in mean sleep latency on the maintenance of wakefulness test from Baseline to Visit 4. [ Time Frame: Baseline, Visit 3 and 4 ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
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
Other Name: LCM
|Placebo Comparator: Sugar pill||
Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
Other Name: Control
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01190098
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Nancy Foldvary-Schaefer, DO||Cleveland Clinic Neurological Institue|