EPICAT: Interest of a Specific Care Pathway for the Management of Catamenial Epilepsy

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05898152

Collaborator

(none)

Enrollment

Location

18.1

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a study of patients with catamenial epilepsy. Catamenial epilepsies are defined as epileptic seizures during the menstrual cycle. Today, there are no recommendations and no care pathway for these patients. The aim of this study is to assess the number of patients reporting a link between the occurrence of their epileptic seizures and their menstrual cycle.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy Menstrual	Other: Data collection

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Interest of a Specific Care Pathway for the Management of Catamenial Epilepsy Catamenial Epilepsy: Status Report and Point of View of a Cohort of Patients Who for Drug-resistant Epilepsy at the TOULOUSE University Hospital

Actual Study Start Date :

May 3, 2023

Anticipated Primary Completion Date :

May 3, 2024

Anticipated Study Completion Date :

Nov 3, 2024

Arms and Interventions

Arm	Intervention/Treatment
Adult patients with catamenial epilepsy A questionnaire regarding the menstrual cycle and the catamenial epilepsy will be administrated to the participants.	Other: Data collection A collection about patient's data demographic, neurologic and gynecologic follow-up and satisfaction will be review by questionnaire. And a calendar of epileptic seizures will be completed by patients on 4 months

Arm

Intervention/Treatment

Adult patients with catamenial epilepsy

A questionnaire regarding the menstrual cycle and the catamenial epilepsy will be administrated to the participants.

Other: Data collection

A collection about patient's data demographic, neurologic and gynecologic follow-up and satisfaction will be review by questionnaire. And a calendar of epileptic seizures will be completed by patients on 4 months

Outcome Measures

Primary Outcome Measures

Number of reporting patients [4 months]
Number and proportion of patients reporting having a link between the onset of their epileptic seizures and their menstrual cycle based on the questionnaire they completed.

Secondary Outcome Measures

Listening satisfaction [4 months]
Questionnaire about listening satisfaction by the professional
Satisfaction of taking charge [4 months]
Questionnaire about satisfaction of management by the professional
Rate of women with drug-resistant epilepsy [4 months]
Collection calendar
Reconciliation of catamenial epilepsy [4 months]
Comparison of epilepsy collection calendar and questionnaire. The questionnaire includes demographic data, neurological demographic data, their neurological and gynaecological follow-up, and also their satisfaction with their care and the information received on their pathology.
Association between catamenial epilepsy and menstrual cycle [4 months]
Research of an association between catamenial epilepsy and menstrual cycle
Existing associations [4 months]
Evaluate link between different factors obtained during the collection (contraceptions, epileptics, menstrual cycle disorders, etc.) and the presence of catamenial epilepsy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults patients (>18 years)
No menopausal
Patients who have consulted in a Neurology department for refractory epilepsy
Non opposition patient
Affiliation to a social security scheme

Exclusion Criteria:

Patients who understand French enough

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Toulouse	Toulouse		France	31059

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

Principal Investigator: Anna GOSSET, MD, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Toulouse

ClinicalTrials.gov Identifier:

NCT05898152

Other Study ID Numbers:

RC31/23/0055
2023-A00280-45

First Posted:

Jun 12, 2023

Last Update Posted:

Jun 12, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Toulouse

Catamenial epilepsy

Menstrual cycle

Additional relevant MeSH terms:

Epilepsy

Study Results

No Results Posted as of Jun 12, 2023