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

Phase 3

Terminated

• Conditions: Epilepsy, Partial
• Interventions: Drug: Lacosamide; Drug: Levetiracetam

• Registration Number: NCT01375374
• Lead Sponsor: UCB Pharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-09
• Study First Submitted QC: 2011-06-16
• Study First Posted: 2011-06-17
• Study Start: 2011-07
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Disposition First Submitted: 2013-12-13
• Disposition First Submitted QC: 2013-12-13
• Disposition First Posted: 2014-01-15
• Results First Submitted: 2014-11-20
• Results First Submitted QC: 2014-11-20
• Results First Posted: 2014-11-26
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-28
• Last Update Posted: 2017-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 11

Inclusion Criteria

• Male subject with diagnosis of Epilepsy with Partial-Onset Seizures
• Subject only taking Levetiracetam in combination with Carbamazepine as adjunctive treatment for Epilepsy

Exclusion Criteria

• Subject is taking another Anti-Epileptic Drug (AED) than Carbamazepine (CBZ) and Levetiracetam (LEV)
• Subject is taking lipid lowering agents
• Subject is taking enzyme inducers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lacosamide	Lacosamide	commercial 50 mg (pinkish) and 100 mg (yellow) tablets
Lacosamide	Levetiracetam	commercial 50 mg (pinkish) and 100 mg (yellow) tablets

Primary Outcome Measures

Name	Time	Method
Change in Serum Sex Hormone Binding Globulin (SHBG) From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)	From Day 1 (Baseline) to Day 84 (Treatment Period End)	Due to premature termination of enrollment prior to achieving the planned sample size (a total of 28 subjects), this primary safety variable was assessed for descriptive purposes only. A negative value indicates an improvement.

Secondary Outcome Measures

Name	Time	Method
Change in Sex Hormone Calculated Free Androgen Index Levels From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)	From Day 1 (Baseline) to Day 84 (Treatment Period End)	The change in sex hormone calculated free androgen index (100 x Testosterone/sex hormone binding globulin) levels from Baseline to the end of Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement.
Change in Serum Thyroid Hormone Free Thyroxine Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)	From Day 1 (Baseline) to Day 84 (Treatment Period End)	The change in the serum thyroid hormone free thyroxine level from Baseline to the end of the Maintenance Period was summarized descriptively by visit.
Change in Total Cholesterol Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)	From Day 1 (Baseline) to Day 84 (Treatment Period End)	The change in total cholesterol levels from Baseline to the end of the Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement.

Trial Locations

Locations (7)

2; 🇩🇪 Bielefeld, Germany

12; 🇦🇹 Salzburg, Austria

22; 🇪🇸 Alcorcon, Spain

1; 🇩🇪 Bonn, Germany

5; 🇩🇪 Erlangen, Germany

11; 🇦🇹 Innsbruck, Austria

20; 🇪🇸 Santiago de Compostela, Spain