- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01530386
A Multicenter, Open-label Study to Determine the Effects of Lacosamide on Sleep in Healthy Subjects
August 16, 2012 updated by: UCB Pharma
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Little Rock, Arkansas, United States
- 005
-
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Ohio
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Cleveland, Ohio, United States
- 003
-
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Texas
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Austin, Texas, United States
- 004
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Virginia
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Fredericksburg, Virginia, United States
- 001
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lacosamide
300 mg/day
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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.
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Baseline to end of Treatment Period (approximately 22 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change In Sleep Efficiency From Baseline To The End Of The Treatment Period
Time Frame: Baseline to end of Treatment Period (approximately 22 days)
|
Sleep efficiency is the percentage calculated by taking the total sleep time divided by the time in bed.
|
Baseline to end of Treatment Period (approximately 22 days)
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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)
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Total Sleep Time is the total of all sleep epochs within time in bed.
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Baseline to end of Treatment Period (approximately 22 days)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
February 7, 2012
First Submitted That Met QC Criteria
February 7, 2012
First Posted (Estimate)
February 9, 2012
Study Record Updates
Last Update Posted (Estimate)
August 20, 2012
Last Update Submitted That Met QC Criteria
August 16, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SP1031
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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