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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Epilepsy, Partial

Intervention / Treatment
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* Drug: Lacosamide
* Drug: Levetiracetam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lacosamide<br>commercial 50 mg (pinkish) and 100 mg (yellow) tablets | Drug: Lacosamide<br>* 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.<br>* Other names: Vimpat;Drug: Levetiracetam<br>* 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.<br>* Other names: Keppra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | From Day 1 (Baseline) to Day 84 (Treatment Period End) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | From Day 1 (Baseline) to Day 84 (Treatment Period End) | 
| 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) | The change in the serum thyroid hormone free thyroxine level from Baseline to the end of the Maintenance Period was summarized descriptively by visit. | From Day 1 (Baseline) to Day 84 (Treatment Period End) | 
| Change in Total Cholesterol Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) | 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. | From Day 1 (Baseline) to Day 84 (Treatment Period End) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vimpat, Partial seizures, Carbamazepine, Hormone levels, Lipid levels, Lacosamide