NCT01375374

Hormonal and Lipid Levels in Male Subjects After a Switch From Carbamazepine to Lacosamide

Multicenter, Open-label, Single-arm Study to Evaluate Hormone and Lipid Levels in Male Subjects With Partial-onset Seizures After a Switch of Treatment From Carbamazepine as Adjunctive Treatment to Levetiracetam to Lacosamide as Adjunctive Treatment to Levetiracetam

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the trial is to investigate whether changes in lipids and hormonal parameters can be observed in blood when Carbamazepine treatment is replaced with Lacosamide treatment, while Levetiracetam treatment remains unchanged.

Conditions

• Epilepsy, Partial

Interventions

Type	Name	Description
DRUG	Lacosamide	4-Week Titration Period: start dose Lacosamide (LCM) is 100 mg/day - up-titration of 100 mg/week LCM 8-Week Maintenance Period: dose can change first 4 weeks with 100 mg/week, must remain between 300 mg/day and 600 mg/day. Dose must remain stable last 4 weeks.
DRUG	Levetiracetam	Levetiracetam (LEV) is taken at a stable dose 30 days before study entry and is ≥ 1000 mg/day at the first visit. The LEV dose may not be changed at any time.

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2011-06-17
• Last updated: 2017-08-28
• Results posted: 2014-11-26

Locations

7 sites across 3 countries: Austria, Germany, Spain