Epilepsy MenstrualEPICATNCT05898152
Interest of a Specific Care Pathway for the Management of Catamenial Epilepsy
An observational study of Epilepsy Menstrual, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epilepsy Menstrual
- What is being tested?
- Data collection
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2023to 3 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with catamenial epilepsy
Who may be able to join
- 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
Who cannot join
- Patients who understand French enough
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Epilepsy Menstrual
- Being tested
- Data collection
- Keywords
- Catamenial epilepsy, Menstrual cycle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with catamenial epilepsy | A questionnaire regarding the menstrual cycle and the catamenial epilepsy will be administrated to the participants. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (6)
Listening satisfaction
Questionnaire about listening satisfaction by the professional
Measured: 4 months
Satisfaction of taking charge
Questionnaire about satisfaction of management by the professional
Measured: 4 months
Rate of women with drug-resistant epilepsy
Collection calendar
Measured: 4 months
Reconciliation of catamenial epilepsy
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.
Measured: 4 months
Association between catamenial epilepsy and menstrual cycle
Research of an association between catamenial epilepsy and menstrual cycle
Measured: 4 months
Existing associations
Evaluate link between different factors obtained during the collection (contraceptions, epileptics, menstrual cycle disorders, etc.) and the presence of catamenial epilepsy
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start3 May 2023
- Primary completion3 May 2024 (estimated)
- Study completion3 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy MenstrualStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna GOSSET, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898152
- Sponsor's protocol ID
- RC31/23/0055
- Other IDs
- 2023-A00280-45
- Acronym
- EPICAT
- Status last verified
- May 2023
- First submitted
- 15 May 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05898152
- Acronym / sponsor ID
- EPICAT / RC31/23/0055
- Conditions
- Epilepsy Menstrual
- Keywords
- Catamenial epilepsy, Menstrual cycle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 3 May 2024 (estimated)
- Study completion
- 3 Nov 2024 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with catamenial epilepsy | – | Other: Data collectionA questionnaire regarding the menstrual cycle and the catamenial epilepsy will be administrated to the participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with catamenial epilepsy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who understand French enough
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionA 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 | Other | Adult patients with catamenial epilepsy |
Primary outcome
Number of reporting patients
Time frame: 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.
6 secondary outcomes
Listening satisfaction
Time frame: 4 months
Satisfaction of taking charge
Time frame: 4 months
Rate of women with drug-resistant epilepsy
Time frame: 4 months
Reconciliation of catamenial epilepsy
Time frame: 4 months
Association between catamenial epilepsy and menstrual cycle
Time frame: 4 months
Existing associations
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna GOSSET, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy Menstrual, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of reporting patients (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.