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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacosamide | Experimental | 300 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change In Wake After Sleep Onset From Baseline To The End Of The Treatment Period | 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. | Baseline to end of Treatment Period (approximately 22 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change In Sleep Efficiency From Baseline To The End Of The Treatment Period | 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) |
| Change In Total Sleep Time From Baseline To The End Of The Treatment Period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | 877-822-9493 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 005 | Little Rock | Arkansas | United States | |||
| 003 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25468512 | Derived | 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. |
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| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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|
Total Sleep Time is the total of all sleep epochs within time in bed. |
| Baseline to end of Treatment Period (approximately 22 days) |
| Cleveland |
| Ohio |
| United States |
| 004 | Austin | Texas | United States |
| 001 | Fredericksburg | Virginia | United States |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |