Impact of Eslicarbazepine Acetate on Lipid Metabolism and... | NCT02573272

Studies
Impact of Eslicarbazepine Acetate on Lipid Metabolism and Cardiovascular Risk Factors

NCT02573272

Sponsor

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

Status

Unknown status

Last Update Posted

Oct 9, 2015Estimated

Enrollment

204Estimated

Phase

Not provided

Conditions

Epilepsy

Interventions

eslicarbacepine

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Jul 2016Estimated

Completion Date

Oct 2016Estimated

First Submitted Date

Sep 30, 2015

First Submission Date that Met QC Criteria

Oct 8, 2015

First Posted Date

Oct 9, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2015

Last Update Posted Date

Oct 9, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

204Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Epileptic patients with AEDs and eslicarbacepine			Drug: eslicarbacepine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
eslicarbacepine	Drug		Epileptic patients with AEDs and eslicarbacepine

Measure	Description	Time Frame
Carotid IMT millimeters		one year

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
María del Mar Benjumea	Contact	955 040 460		maria.benjumea@juntadeandalucia.es

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Torrecardenas	Recruiting	Almería	Almeria	04009	Spain

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided