Intracranial Pressure During Migraine

NCT ID: NCT03152305

Last Updated: 2017-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-21

Study Completion Date

2018-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

An increase in intracranial pressure (ICP) during migraine attacks is possible and could contribute to pain initiation and maintenance. From now on, it was not possible to measure ICP in a non-invasive way. The development of a new tool allows non-invasive self-measures of ICP variations. Thus, it is possible for the first time to look for such ICP variations during migraine attacks and to conclude if this mechanism is implied in the pathophysiology of migraine.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Womens presenting with regular menstrual migraine treated with triptans will be included in the study. Self-measure of ICP will be performed outside and during menstrual migraine attacks. The potential variations will be compared to the measures done on matched healthy women outside and during menses.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Menstrual Migraine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Women with menstrual migraine

Womens presenting with regular menstrual migraine treated with triptans will be included in the study.

Intracranial pressure variations

Intervention Type OTHER

Self-measure of ICP will be performed outside and during menstrual migraine attacks.

Matched control

The potential variations will be compared to the measures done on matched healthy women outside and during menses.

Intracranial pressure variations

Intervention Type OTHER

Self-measure of ICP will be performed outside and during menstrual migraine attacks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intracranial pressure variations

Self-measure of ICP will be performed outside and during menstrual migraine attacks.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 to 50 non menopausal women
* Menstrual migraine
* Using a triptan as usual treatment to relieve attacks
* Usual triptan efficacy although recurrence is possible

Exclusion Criteria

* Disease of the ear
* Intracranial hypertension
* Chronic daily headache
* Use of topiramate or acetazolamide
* Triptans used more than 10 days/month
* Analgesic drug used more than 15 days/month
* Uncontrolled high blood pressure
* BMI \>30
* Ongoing allergic rhinitis or flu
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Clermont-Ferrand

Clermont-Ferrand, Auvergne, France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Patrick LACARIN

Role: CONTACT

04 73 75 11 95

Pierre CLAVELOU

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Patrick LACARIN

Role: primary

04 73 75 11 95

Pierre CLAVELOU

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014-A00042-45

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-331

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study of Wearable Devices to Predict Migraines
NCT05755945 ENROLLING_BY_INVITATION NA