Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy
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|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|
|Actual Primary Completion Date :||November 2014|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|