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

UCB

Status and phase: Terminated; Phase 3

Conditions: Epilepsy, Partial

Treatments: Drug: Levetiracetam; Drug: Lacosamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01375374

SP0978

2010-022534-84 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Lacosamide

Experimental group

Description:

commercial 50 mg (pinkish) and 100 mg (yellow) tablets

Treatment:

Drug: Lacosamide

Drug: Levetiracetam