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Impact of Eslicarbazepine Acetate on Lipid Metabolism and Cardiovascular Risk Factors

Primary Purpose

Epilepsy

Status
Unknown status
Phase
Locations
Spain
Study Type
Observational
Intervention
eslicarbacepine
Sponsored by
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital TorrecardenasRecruiting

Arms of the Study

Arm 1

Arm Type

Arm Label

Epileptic patients with AEDs and eslicarbacepine

Arm Description

Outcomes

Primary Outcome Measures

Carotid IMT millimeters

Secondary Outcome Measures

Full Information

First Posted
September 30, 2015
Last Updated
October 8, 2015
Sponsor
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
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1. Study Identification

Unique Protocol Identification Number
NCT02573272
Brief Title
Impact of Eslicarbazepine Acetate on Lipid Metabolism and Cardiovascular Risk Factors
Official Title
Impact of Eslicarbazepine Acetate on Lipid Metabolism and Cardiovascular Risk Factors
Study Type
Observational

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epileptic patients with AEDs and eslicarbacepine
Intervention Type
Drug
Intervention Name(s)
eslicarbacepine
Primary Outcome Measure Information:
Title
Carotid IMT millimeters
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Population Description
Patients diagnosed with focal epilepsy on stable treatment for the last two years
Sampling Method
Probability Sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
María del Mar Benjumea
Phone
955 040 460
Email
maria.benjumea@juntadeandalucia.es
Facility Information:
Facility Name
Hospital Torrecardenas
City
Almería
State/Province
Almeria
ZIP/Postal Code
04009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Serrano

12. IPD Sharing Statement

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Impact of Eslicarbazepine Acetate on Lipid Metabolism and Cardiovascular Risk Factors

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