A Multicenter, Open-label Study to Determine the Effects of Lacosamide on Sleep in Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT01530386|
Recruitment Status : Completed
First Posted : February 9, 2012
Last Update Posted : August 20, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy Subjects||Drug: Lacosamide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-label Study to Determine the Effects of Lacosamide on Sleep in Healthy Subjects|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
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.
- 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.
- 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.
- 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) ]Total Sleep Time is the total of all sleep epochs within time in bed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530386
|United States, Arkansas|
|Little Rock, Arkansas, United States|
|United States, Ohio|
|Cleveland, Ohio, United States|
|United States, Texas|
|Austin, Texas, United States|
|United States, Virginia|
|Fredericksburg, Virginia, United States|
|Study Director:||UCB Clinical Trial Call Center||877-822-9493|