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
Overview
- Phase
- Phase 3
- Intervention
- Lacosamide
- Conditions
- Epilepsy, Partial
- Sponsor
- UCB Pharma
- Enrollment
- 11
- Locations
- 7
- Primary Endpoint
- 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)
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Lacosamide
commercial 50 mg (pinkish) and 100 mg (yellow) tablets
Intervention: Lacosamide
Lacosamide
commercial 50 mg (pinkish) and 100 mg (yellow) tablets
Intervention: Levetiracetam
Outcomes
Primary Outcomes
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)
Time Frame: 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 Outcomes
- 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))
- 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))
- 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))