NCT02573272

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 9, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 9, 2015

Status Verified

September 1, 2015

Enrollment Period

1.1 years

First QC Date

September 30, 2015

Last Update Submit

October 8, 2015

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Carotid IMT millimeters

    one year

Study Arms (1)

Epileptic patients with AEDs and eslicarbacepine

Drug: eslicarbacepine

Interventions

eslicarbacepineDRUG
Epileptic patients with AEDs and eslicarbacepine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Torrecardenas

Almería, Almeria, 04009, Spain

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

María del Mar Benjumea

CONTACT

955 040 460maria.benjumea@juntadeandalucia.es

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 9, 2015

Study Start

June 1, 2015

Primary Completion

July 1, 2016

Study Completion

October 1, 2016

Last Updated

October 9, 2015

Record last verified: 2015-09

Locations

ES(1)