NCT01530386

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-02-09
• Last updated: 2012-08-20

Locations

4 sites across 1 country: United States