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Impact of Eslicarbazepine Acetate on Lipid Metabolism and Cardiovascular Risk Factors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02573272
Recruitment Status : Unknown
Verified September 2015 by Andalusian Network for Design and Translation of Advanced Therapies ( Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ).
Recruitment status was:  Recruiting
First Posted : October 9, 2015
Last Update Posted : October 9, 2015
Sponsor:
Information provided by (Responsible Party):
Andalusian Network for Design and Translation of Advanced Therapies ( 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.

Condition or disease Intervention/treatment
Epilepsy Drug: eslicarbacepine

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Study Type : Observational
Estimated Enrollment : 204 participants
Official Title: Impact of Eslicarbazepine Acetate on Lipid Metabolism and Cardiovascular Risk Factors
Study Start Date : June 2015
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

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



Primary Outcome Measures :
  1. Carotid IMT millimeters [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients diagnosed with focal epilepsy on stable treatment for the last two years
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573272


Contacts
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Contact: María del Mar Benjumea 955 040 460 maria.benjumea@juntadeandalucia.es

Locations
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Spain
Hospital Torrecardenas Recruiting
Almería, Almeria, Spain, 04009
Contact: Pedro Serrano         
Sponsors and Collaborators
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
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Responsible Party: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT02573272    
Other Study ID Numbers: FPS-ESL-2105-01
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases