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

NCT01190098 | Completed Phase 4 Results DMC

• 1 other identifier: UCB-SLEEP
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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

Conditions

Partial Epilepsy

Keywords

Partial epilepsy; Excessive daytime sleepiness; Epworth Sleepiness Scale; Maintenance of Wakefulness Test

Outcome Measures

Primary Outcomes (1)

• Change in Epworth Sleepiness Scale Score From Baseline to Visit 4

  Scale 0 - 24 Higher scores indicate more severe symptoms

  Baseline and Visit 4 (approximately 1 - 2 months)

Secondary Outcomes (7)

• Change in the Fatigue Severity Scale From Baseline to Visit 4.

  Baseline to Visit 4 (approximately 1 - 2 months)

• Change in Pittsburgh Sleep Quality Inventory (PSQI) From Baseline to Visit 4

  Baseline to Visit 4 (approximately 1 - 2 months)

• Change in Functional Outcomes of Sleep Questionnaire (FOSQ) From Baseline to Visit 4.

  Baseline to visit 4 (approximately 1 - 2 months)

• Change in Adverse Event Profile (AEP) From Baseline to Visit 4.

  Baseline to visit 4 (approximately 1 - 2 months)

• Change in Patient Health Questionnaire-9 (PHQ-9) From Baseline to Visit 4.

  Baseline to visit 4 (approximately 1 - 2 months)

Study Arms (2)

Lacosamide

EXPERIMENTAL

Drug: Lacosamide

Sugar pill

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lacosamide DRUG

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

Also known as: LCM

Lacosamide

Placebo DRUG

Placebo will be packaged identically to experimental drug and titrated according to the same schedule.

Also known as: Control

Sugar pill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• UCB Pharma: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Epilepsies, Partial; Disorders of Excessive Somnolence

Interventions

Lacosamide

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Results Point of Contact

• Title: Nancy Foldvary-Schaefer, DO, MS
• Organization: Cleveland Clinic

foldvan@ccf.org

216-445-2990

Study Officials

• Nancy Foldvary-Schaefer, DO

  Cleveland Clinic Neurological Institue

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2010
• First Posted: August 27, 2010
• Study Start: August 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 5, 2016
• Results First Posted: December 5, 2016

Record last verified: 2016-12

Locations

US (1)