A Multicenter, Open-label Study to Determine the Effects of Lacosamide on Sleep in Healthy Subjects

NCT ID: NCT01530386

Last Updated: 2012-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-07-31

Brief Summary

The effects of Lacosamide, an antiepileptic drug, on sleep have not been formally evaluated. The present study is being conducted to assess the effects of Lacosamide on sleep quality in healthy subjects.

Detailed Description

In some patients with Epilepsy, seizure activity is associated with specific phases of sleep/wake cycle, and sleep deprivation is known to precipitate seizure activity. Inadequate or disturbed sleep and excessive daytime drowsiness is often reported by patients with Epilepsy due to the effects of seizures as well as antiepileptic drugs. Thus, the use of healthy subjects improves the certainty that any changes in sleep are related to the study drug and not other factors.

Conditions

Healthy Subjects

Keywords

Lacosamide; Vimpat

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Lacosamide

300 mg/day

Group Type: EXPERIMENTAL

Lacosamide

Intervention Type: DRUG

Lacosamide will be given orally in 50 mg tablets twice a day for 7 days. The dose will increase weekly by 100 mg per day to a target dose of 300 mg per day. Once the target dose of 300 mg per day has been achieved for 9 days, a 2-day tapering of Lacosamide will occur by 100 mg per day.

Interventions

Lacosamide

Lacosamide will be given orally in 50 mg tablets twice a day for 7 days. The dose will increase weekly by 100 mg per day to a target dose of 300 mg per day. Once the target dose of 300 mg per day has been achieved for 9 days, a 2-day tapering of Lacosamide will occur by 100 mg per day.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Reliable and capable subject who signs an IRB approved consent form
• Subject is male or female between 18 and 50 years old whose normal Body Mass Index (BMI) is between 18 and 28 kg/m^2
• Subject has no clinically relevant cardiovascular, renal, gastrointestinal, hepatic, metabolic, endocrine, neurological or psychiatric abnormalities
• Subject is in good health who has good sleep hygiene and normal bed times between 21:00 and 01:00 hours

Exclusion Criteria

• Subjects who have participated in previous Lacosamide studies or received Lacosamide
• Subjects who have received another investigational medication within 30 days or currently participating in an investigational study
• Subject has a history of or screening polysomnography that reveals sleep disorders (i.e. sleep apnea or narcolepsy)
• Subject consumes more than 400 mg of caffeine per day
• Subject has known hypersensitivity to Lacosamide
• Subject has alcohol or drug abuse within last 2 years
• Subject who consumes more than 40 g of alcohol per day
• Subject has a positive alcohol breath test or urine drug screen
• Subject smokes more than half a pack of cigarettes per day or consumes nicotine products
• Subject is pregnant / nursing or child-bearing potential female not sterile or using contraception methods
• Subject is male who does not agree to use contraception
• Subjects taking any medications currently or within 2 weeks prior to first dose except non-steroidal anti-inflammatory drugs, oral contraceptives, and non-psychoactive supplements
• Subject has elevated live enzymes greater than 2 times the upper limit of normal
• Subject has donated blood or had blood loss greater than 400 mL within 3 months prior to first dose
• Subject has out of range hematology or chemistry parameters
• Subject has clinically relevant abnormality in physical examination or vital signs
• Subject has sick sinus syndrome without a pace maker or second or third degree atrioventricular block or clinically significant electrocardiogram finding
• Subject has sodium channelopathy
• Subject has experienced a myocardial infarction in last 3 months
• Subject has New York Heart Association Class III or IV heart failure
• Subject has a lifetime history of suicide attempts
• Subject has any medical or psychiatric condition
• Subject has a known history or severe anaphylactic reaction or serious blood dyscrasias

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

877-822-9493

Locations

005

Little Rock, Arkansas, United States

003

Cleveland, Ohio, United States

004

Austin, Texas, United States

001

Fredericksburg, Virginia, United States

Countries

United States

References

Hudson JD, Guptill JT, Byrnes W, Yates SL, Williams P, D'Cruz O. Assessment of the effects of lacosamide on sleep parameters in healthy subjects. Seizure. 2015 Feb;25:155-9. doi: 10.1016/j.seizure.2014.10.012. Epub 2014 Oct 25.

Reference Type: DERIVED

PMID: 25468512 (View on PubMed)

Other Identifiers

SP1031

Identifier Type: -

Identifier Source: org_study_id