Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy
|ClinicalTrials.gov Identifier: NCT01190098|
Recruitment Status : Completed
First Posted : August 27, 2010
Results First Posted : December 5, 2016
Last Update Posted : December 5, 2016
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
|Condition or disease||Intervention/treatment||Phase|
|Partial Epilepsy||Drug: Lacosamide Drug: Placebo||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||August 2010|
|Primary Completion Date :||November 2014|
|Study Completion Date :||November 2014|
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
- Change in Epworth Sleepiness Scale Score From Baseline to Visit 4 [ Time Frame: Baseline and Visit 4 (approximately 1 - 2 months) ]Scale 0 - 24 Higher scores indicate more severe symptoms
- Change in the Fatigue Severity Scale From Baseline to Visit 4. [ Time Frame: Baseline to Visit 4 (approximately 1 - 2 months) ]Fatigue Severity Scale (FSS): Range 7- 63 where higher scores indicate more severe fatigue.
- Change in Pittsburgh Sleep Quality Inventory (PSQI) From Baseline to Visit 4 [ Time Frame: Baseline to Visit 4 (approximately 1 - 2 months) ]Range 0-21, where higher scores more impairment (in terms of sleep quality).
- Change in Functional Outcomes of Sleep Questionnaire (FOSQ) From Baseline to Visit 4. [ Time Frame: Baseline to visit 4 (approximately 1 - 2 months) ]Range 0-20 where lower scores indicate more impairment (sleep related QOL).
- Change in Adverse Event Profile (AEP) From Baseline to Visit 4. [ Time Frame: Baseline to visit 4 (approximately 1 - 2 months) ]Range 19-76, where higher scores indicate more severe impairment (in terms of 19 common antiepileptic drug side effects.
- Change in Patient Health Questionnaire-9 (PHQ-9) From Baseline to Visit 4. [ Time Frame: Baseline to visit 4 (approximately 1 - 2 months) ]Range 0-27, where higher scores indicate more impairment (depressive symptoms)
- Change in Daily Seizure Frequency From Baseline to Visit 4 [ Time Frame: Baseline to visit 4 (approximately 1 - 2 months) ]Number of seizures per day.
- Change in Quality of Life in Epilepsy (QOLIE-31) From Baseline to Visit 4 [ Time Frame: Baseline to visit 4 (approximately 1 - 2 months) ]Range 0 -10 where higher scores reflect better quality of life.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190098
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Nancy Foldvary-Schaefer, DO||Cleveland Clinic Neurological Institue|