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

This study has been completed.
UCB Pharma
Information provided by (Responsible Party):
The Cleveland Clinic Identifier:
First received: August 24, 2010
Last updated: December 1, 2016
Last verified: December 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 Intervention Phase
Partial Epilepsy
Drug: Lacosamide
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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

Resource links provided by NLM:

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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.

Enrollment: 59
Study Start Date: August 2010
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lacosamide Drug: Lacosamide

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 Drug: Placebo
Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
Other Name: Control

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Subjects must meet the following inclusion criteria to be eligible for the study.

  • Subject can provide written informed consent and is willing to comply with study procedures.
  • Subject is at least 18 years of age.
  • Subject has focal epilepsy with classifiable seizures according to the International Classification of Epileptic Seizures, 1981.11
  • Subject is deemed to be an appropriate candidate for LCM adjunctive therapy.
  • Subject has been maintained on a stable dose of 1 or 2 marketed AEDs for at least 4 weeks.

Exclusion Criteria:

Subjects must meet the following exclusion criteria to be eligible for the study.

  • Subject has a history of a moderate or severe sleep apnea (apnea-hypopnea index [AHI] > 15), severe insomnia (habitual sleep duration < 4 hours) or narcolepsy.
  • Subject has a score on the Sleep Apnea Scale of the Sleep Disorders Questionnaire (SA/SDQ) at screening of 32 or higher (female) and 36 or higher (male).
  • Subject is currently participating or has participated within the last 2 months in a trial of an investigational drug or experimental device.
  • Subject has seizures or seizures clusters that are not quantifiable.
  • Subject has 6 or more seizures (excluding auras) in the 2-week Baseline Phase.
  • Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism or excretion.
  • Subject has any medical or psychiatric condition, which in the opinion of the investigator, could jeopardize the subject's health or would compromise the - Subject has a history of alcohol or drug abuse within the previous 2 years.
  • Subject has an acute or sub-acutely progressive central nervous system disease.
  • Subject is pregnant, breastfeeding or of childbearing age and not surgically sterile or practicing an acceptable form of contraception (barrier contraception, surgically sterilized, IUD, abstinence) for the duration of the trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01190098

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
UCB Pharma
Principal Investigator: Nancy Foldvary-Schaefer, DO Cleveland Clinic Neurological Institue
  More Information

Responsible Party: The Cleveland Clinic Identifier: NCT01190098     History of Changes
Other Study ID Numbers: UCB-SLEEP
Study First Received: August 24, 2010
Results First Received: December 1, 2016
Last Updated: December 1, 2016

Keywords provided by The Cleveland Clinic:
Partial epilepsy
Excessive daytime sleepiness
Epworth Sleepiness Scale
Maintenance of Wakefulness Test

Additional relevant MeSH terms:
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anticonvulsants processed this record on May 22, 2017