NCT05898152

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.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2024

Completed
Last Updated

June 12, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

May 15, 2023

Last Update Submit

May 31, 2023

Conditions

Keywords

Catamenial epilepsyMenstrual cycle

Outcome Measures

Primary Outcomes (1)

  • Number of reporting patients

    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.

    4 months

Secondary Outcomes (6)

  • Listening satisfaction

    4 months

  • Satisfaction of taking charge

    4 months

  • Rate of women with drug-resistant epilepsy

    4 months

  • Reconciliation of catamenial epilepsy

    4 months

  • Association between catamenial epilepsy and menstrual cycle

    4 months

  • +1 more secondary outcomes

Study Arms (1)

Adult patients with catamenial epilepsy

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

Other: Data collection

Interventions

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

Adult patients with catamenial epilepsy

Eligibility Criteria

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

Women with catamenial epilepsy

You may qualify if:

  • 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

You may not qualify if:

  • Patients who understand French enough

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Anna GOSSET, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2023

First Posted

June 12, 2023

Study Start

May 3, 2023

Primary Completion

May 3, 2024

Study Completion

November 3, 2024

Last Updated

June 12, 2023

Record last verified: 2023-05

Locations