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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by The Cleveland Clinic
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01190098
First received: August 24, 2010
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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, Visit 3, 4 and 6 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in mean sleep latency on the maintenance of wakefulness test from Baseline to Visit 4. [ Time Frame: Baseline, Visit 3 and 4 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 55
Study Start Date: August 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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 ClinicalTrials.gov identifier: NCT01190098

Contacts
Contact: Nancy Foldvary-Schaefer, DO (216) 445-2990 foldvan@ccf.org
Contact: Monica Bruton (216)-444-6718 brutonm@ccf.org

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

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01190098     History of Changes
Other Study ID Numbers: UCB-SLEEP
Study First Received: August 24, 2010
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lacosamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014