Impact of Eslicarbazepine Acetate on Lipid Metabolism and Cardiovascular Risk Factors

Epilepsy Clinical Trial

Official title:

Impact of Eslicarbazepine Acetate on Lipid Metabolism and Cardiovascular Risk Factors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02573272
• Other study ID #: FPS-ESL-2105-01
• Status: Recruiting
• Phase: N/A
• First received: September 30, 2015
• Last updated: October 8, 2015
• Start date: June 2015
• Est. completion date: October 2016

Study information

• Verified date: September 2015
• Source: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Contact: María del Mar Benjumea
• Phone: 955 040 460
• Email: maria.benjumea[@]juntadeandalucia.es
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

N/A

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• eslicarbacepine

Locations

Country	Name	City	State
Spain	Hospital Torrecardenas	Almería	Almeria

Sponsors (1)

Lead Sponsor	Collaborator
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carotid IMT millimeters		one year	No