Status:
COMPLETED
Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
UCB Pharma
Conditions:
Partial Epilepsy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 medica...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01190098
Start Date
August 1 2010
End Date
November 1 2014
Last Update
December 5 2016
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195