Impact of Eslicarbazepine Acetate on Lipid Metabolism and Cardiovascular Risk Factors

October 8, 2015 updated by: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

204

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Almeria
      • Almería, Almeria, Spain, 04009
        • Recruiting
        • Hospital Torrecardenas
        • Contact:
          • Pedro Serrano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients diagnosed with focal epilepsy on stable treatment for the last two years

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Epileptic patients with AEDs and eslicarbacepine
Drug: eslicarbacepine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Carotid IMT millimeters
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

September 30, 2015

First Submitted That Met QC Criteria

October 8, 2015

First Posted (Estimate)

October 9, 2015

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

October 8, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPS-ESL-2105-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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