Impact of Eslicarbazepine Acetate on Lipid Metabolism and Cardiovascular Risk Factors

• Conditions: Epilepsy
• Interventions: Drug: eslicarbacepine

• Registration Number: NCT02573272
• Lead Sponsor: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

Brief Summary

Knowing the impact that the use of ESL as adjunctive treatment of partial epilepsy has on cardiovascular risk factors measured by biochemical and ultrasound parameters compared with enzyme-inducing AEDs.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Status Verified: 2015-09
• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-10-08
• Last Update Submitted: 2015-10-08
• Study First Posted: 2015-10-09
• Last Update Posted: 2015-10-09
• Primary Completion: 2016-07
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

• Patients over 18 years
• patients definitively diagnosed Focal Epilepsy based on clinical criteria and additional tests.
• patients with stable and identifiable antiepileptic treatment during the last two years.
• patients according to the investigator are able to provide clinical data necessary for the development of the study
• Patients who signed informed consent

Exclusion Criteria

• Patients who, according to their evolution and demands of clinical practice, their previous treatment has to be changed for this reason breach inclusion criteria and / or attachment to one of the study groups.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Epileptic patients with AEDs and eslicarbacepine	eslicarbacepine	-

Primary Outcome Measures

Name	Time	Method
Carotid IMT millimeters	one year

Trial Locations

Locations (1)

Hospital Torrecardenas; 🇪🇸 Almería, Almeria, Spain