NCT04383522

Brief Summary

The National Registry of Epilepsy in Mexico aims to be an observational, multicenter, and nationwide study about Epilepsy in Mexico. This project is proposed as the first registry about the diagnosis and treatment of epilepsy in Mexico. The participation of major health institutions, both public and private, of each state to ensure that the registry is representative of the country is planned.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

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

May 1, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

May 7, 2020

Last Update Submit

May 7, 2020

Conditions

Outcome Measures

Primary Outcomes (6)

  • Number of patients treated for epilepsy in 70 public hospitals in the health sector in Mexico, divided by age groups.

    We have a database that will be used to capture patients separated by age, newborn, pediatric age and adults, analyzing how many belong to each age group with an individual accounting to know the total absolute number.

    Four months

  • To know the type of epileptic crisis, the type of epilepsy and the type of epileptic syndrome presented by patients who are treated for this disease in 70 public hospitals in the health sector in Mexico.

    We have a database that will be used to capture patients divided by type of epileptic crisis that they present, both focal onset, generalized onset, or unknown onset. By the type of epilepsy that they present either focal, generalized, mixed, both focal and generalized or unknown epilepsy. And those who present characteristics of an epileptic syndrome register them. In this way we will have absolute numbers for each category of these three items.

    Four months

  • Number of patients with epilepsy, separated by etiologies treated in 70 public hospitals in the health sector in Mexico.

    We have a database that will be used to capture patients separated by six specific etiologies, as currently recommended by the International League Against Epilepsy, structural, genetic, immune, infectious, metabolic or unknown, accounting for those who register each group to know the total absolute number.

    Four months

  • To know the type of comorbidity presented by patients treated for Epilepsy in 70 public hospitals in the health sector in Mexico.

    We have a database that will be used to capture the different comorbidities that patients present, some of them may have more than one comorbidity and it is interesting to quantify which are the most frequent of this group of patients treated in hospitals in the sector. public from Mexico regardless of the age of the patient, although later a more frequent sub-analysis can be made by age group and comorbidity.

    Four months

  • To know the type of antiepileptic drugs that have been used and are currently used by patients treated for Epilepsy in 70 public hospitals in the health sector in Mexico.

    We have a database that will be used to capture the drugs previously used by patients with epilepsy and what has been the reason for not taking them anymore, either due to lack of effectiveness or adverse effect, indicating by devices and systems in where it presented the adverse effect. In the same way, the antiepileptic drugs used by patients with epilepsy to control their disease will be known and accounted for.

    Four months

  • Number of patients in spatial groups such as those in the newborn, pregnancy, with epilepsy surgery and with concomitant diseases treated by Epilepsy in 70 public hospitals in the health sector in Mexico.

    We have a database that will be used to capture patients separated by age, newborn, pediatric age and adults, analyzing how many belong to each age group with an individual accounting to know the total absolute number.

    Four months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Candidates for the registry are those patients of any gender and any age who present an Epilepsy diagnosis according to the current definition of the ILAE 2014.

You may qualify if:

  • Patients seen in an institution in the public sector of Mexico that belong to the Epilepsy Priority Program
  • Informed consent and assent of participation in the project
  • Patients with any form of epilepsy
  • Patients seen by a Pediatric Neurologist or Neurologist

You may not qualify if:

  • Patients who decide at any time not to participate
  • Incomplete data of their disease
  • Non-epileptic seizures
  • Inadequate information from the patient, family member or informant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Juan Carlos Resendiz-Aparicio, MD

CONTACT

Arturo Villegas-Ortiz

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 12, 2020

Study Start

May 1, 2020

Primary Completion

May 1, 2021

Study Completion

November 1, 2021

Last Updated

May 12, 2020

Record last verified: 2020-05