Clinical Trial: Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 (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


Detailed Summary:

1.1. Background Epilepsy is a common disorder affecting approximately 1% of the population including nearly 2 million people in the United States. Excessive daytime sleepiness (EDS) is the most common complaint of people with epilepsy, reported in as many 50% of cases. EDS has long been attributed to the effects of antiepileptic drugs (AEDs) and seizures, but this assumption has not been adequately tested. In recent years, primary sleep disorders, such as sleep apnea, have been identified as potential contributors. A recent questionnaire-based study of 486 adults with epilepsy found a 2-fold higher prevalence of sleep disturbances in patients compared with age- matched controls (39% vs.18%). The presence of a sleep disturbance adversely affects quality of life (QOL) in people with epilepsy.

Despite the frequency of EDS in people with epilepsy, surprisingly few have attempted to measure this complaint objectively. In a study presented at the 2007 Annual Meeting of the American Academy of Sleep Medicine (AASM) by the investigators of this proposal, the prevalence of EDS among 92 epilepsy patients was assessed using three measures: self-reported EDS, the Epworth Sleepiness Scale (ESS), a subjective screening tool used in sleep clinics, and the multiple sleep latency test (MSLT), the gold standard objective measurement of daytime sleepiness. Seventy-two percent of subjects endorsed EDS (feeling excessively sleepy at least a few days per week over the last 6 months), 37% had abnormal ESS scores (> 10), and 62% had abnormal MSLTs (mean sleep latency [MSL] < 8 min). The MSL was less than 5 minutes, comparable to that of patients with narcolepsy, in 36% of cases. The correlation between self-reported EDS and the MSL was poor. However, as found in previous studies in sleep populations, a better correlation between the ESS and MSL was found. Among larger epilepsy series using
Sponsor: The Cleveland Clinic

Current Primary Outcome: 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


Original Primary Outcome: Change in Epworth Sleepiness Scale Score From Baseline to Visit 4 [ Time Frame: Baseline, Visit 3, 4 and 6 ]

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Change in mean sleep latency on the maintenance of wakefulness test from Baseline to Visit 4. [ Time Frame: Baseline, Visit 3 and 4 ]

Information By: The Cleveland Clinic

Dates:
Date Received: August 24, 2010
Date Started: August 2010
Date Completion:
Last Updated: December 1, 2016
Last Verified: December 2016