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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01530386
First received: February 7, 2012
Last updated: August 16, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
Drug: Lacosamide
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Multicenter, Open-label Study to Determine the Effects of Lacosamide on Sleep in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Change In Wake After Sleep Onset From Baseline To The End Of The Treatment Period [ Time Frame: Baseline to end of Treatment Period (approximately 22 days) ] [ Designated as safety issue: No ]
    Wake after sleep onset is defined as the total time that is scored as awake in a polysomnography occurring between sleep onset and final wake-up.


Secondary Outcome Measures:
  • Change In Sleep Efficiency From Baseline To The End Of The Treatment Period [ Time Frame: Baseline to end of Treatment Period (approximately 22 days) ] [ Designated as safety issue: No ]
    Sleep efficiency is the percentage calculated by taking the total sleep time divided by the time in bed.

  • Change In Total Sleep Time From Baseline To The End Of The Treatment Period [ Time Frame: Baseline to end of Treatment Period (approximately 22 days) ] [ Designated as safety issue: No ]
    Total Sleep Time is the total of all sleep epochs within time in bed.


Enrollment: 25
Study Start Date: January 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lacosamide
300 mg/day
Drug: 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.
Other Name: Lacosamide

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  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: NCT01530386

Locations
United States, Arkansas
005
Little Rock, Arkansas, United States
United States, Ohio
003
Cleveland, Ohio, United States
United States, Texas
004
Austin, Texas, United States
United States, Virginia
001
Fredericksburg, Virginia, United States
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center 877-822-9493
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01530386     History of Changes
Other Study ID Numbers: SP1031
Study First Received: February 7, 2012
Last Updated: August 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
Lacosamide
Vimpat

Additional relevant MeSH terms:
Lacosamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014