Phase 4 N=52 Randomized Quadruple-blind Treatment

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

Partial Epilepsy

Bottom Line

View on ClinicalTrials.gov: NCT01190098 ↗

Enrolled (actual)

Serious AEs

5.8%

Results posted

Dec 2016

Primary outcome: Primary: Change in Epworth Sleepiness Scale Score From Baseline to Visit 4 — -1.2; -1.1 Units on a scale — p=0.027

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Lacosamide (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: Nov 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Epworth Sleepiness Scale Score From Baseline to Visit 4	-1.2; -1.1	0.027 sig
SECONDARY Change in the Fatigue Severity Scale From Baseline to Visit 4.	0.30; -5.4	0.23
SECONDARY Change in Pittsburgh Sleep Quality Inventory (PSQI) From Baseline to Visit 4	-1.6; -1.3	0.84
SECONDARY Change in Functional Outcomes of Sleep Questionnaire (FOSQ) From Baseline to Visit 4.	0.3; 1.1	0.37
SECONDARY Change in Adverse Event Profile (AEP) From Baseline to Visit 4.	-1.2; -6.0	0.33
SECONDARY Change in Patient Health Questionnaire-9 (PHQ-9) From Baseline to Visit 4.	-1.1; -1.2	0.92
SECONDARY Change in Daily Seizure Frequency From Baseline to Visit 4	0.0; 0.0	0.69
SECONDARY Change in Quality of Life in Epilepsy (QOLIE-31) From Baseline to Visit 4	4.0; 4.2	0.95

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

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01190098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.