Menstrual MigraineMigICPNCT03152305
Intracranial Pressure During Migraine
An observational study of Menstrual Migraine, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Migraine
- What is being tested?
- Intracranial pressure variations
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jul 2014to Jul 2018
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- 18 to 50 non menopausal women
- Menstrual migraine
- Using a triptan as usual treatment to relieve attacks
- Usual triptan efficacy although recurrence is possible
Who cannot join
- 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
Show all 9Show fewer
- Uncontrolled high blood pressure
- BMI >30
- Ongoing allergic rhinitis or flu
Trial locations and contacts
1 site in 1 country.
Pierre CLAVELOU contact
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Pierre CLAVELOU, pclavelou@chu-clermontferrand.fr
About this study
Official title: Measure of Intracranial Pressure Variations During Migraine Attacks
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.
Read the detailed description
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
- Menstrual Migraine
- Being tested
- Intracranial pressure variations
- Keywords
- Migraine, Intracranial pressure, Headache
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracranial pressure variationsOther
Self-measure of ICP will be performed outside and during menstrual migraine attacks.
| Study group | Role | What they receive |
|---|---|---|
| Women with menstrual migraine | Womens presenting with regular menstrual migraine treated with triptans will be included in the study. Receives: Other: Intracranial pressure variations | |
| Matched control | The potential variations will be compared to the measures done on matched healthy women outside and during menses. Receives: Other: Intracranial pressure variations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial pressure variations
Measured during menstrual migraine attacks compared to ICP in non-migraine days and in matched healthy women
Measured: during menstrual migraine attacks
Secondary outcomes (2)
Relationships between ICP variations and clinical parameters
Age, BMI, pain intensity, pulsating pain, allodynia, nausea, photophobia, phonophobia, dizziness, tinnitus
Measured: during menstrual migraine attacks
Relationships between ICP variations and pain relief
Measured: during menstrual migraine attacks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start21 Jul 2014
- Primary completionMay 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual MigraineStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152305
- Sponsor's protocol ID
- CHU-331
- Other IDs
- 2014-A00042-45
- Acronym
- MigICP
- Status last verified
- May 2017
- First submitted
- 11 May 2017
- Last updated
- 15 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measure of Intracranial Pressure Variations During Migraine Attacks
- ClinicalTrials.gov ID
- NCT03152305
- Acronym / sponsor ID
- MigICP / CHU-331
- Conditions
- Menstrual Migraine
- Keywords
- Migraine, Intracranial pressure, Headache
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 21 Jul 2014 (actual)
- Primary completion
- May 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 15 May 2017 (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.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with menstrual migraine | – | Other: Intracranial pressure variationsWomens presenting with regular menstrual migraine treated with triptans will be included in the study. |
| Matched control | – | Other: Intracranial pressure variationsThe potential variations will be compared to the measures done on matched healthy women outside and during menses. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 18 to 50 non menopausal women
- Menstrual migraine
- Using a triptan as usual treatment to relieve attacks
- Usual triptan efficacy although recurrence is possible
Key exclusion criteria (9 listed)
- Disease of the ear
- Intracranial hypertension
- Chronic daily headache
- Use of topiramate or acetazolamide
- Triptans used more than 10 days/month
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 |
|---|---|---|
| Intracranial pressure variationsSelf-measure of ICP will be performed outside and during menstrual migraine attacks. | Other | Matched control, Women with menstrual migraine |
Primary outcome
Intracranial pressure variations
Time frame: during menstrual migraine attacks
Measured during menstrual migraine attacks compared to ICP in non-migraine days and in matched healthy women
2 secondary outcomes
Relationships between ICP variations and clinical parameters
Time frame: during menstrual migraine attacks
Relationships between ICP variations and pain relief
Time frame: during menstrual migraine attacks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
Related trials for Menstrual Migraine
Active, not recruitingPhase 3
Study of Oral Atogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
Menstrual Migraine (MM)
Active, not recruitingPhase 3
Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
Migraine
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine
Menstrual Migraine
Not yet recruiting
Evaluation of the Migraceutics® Phase-Specific Dietary Supplement Regimen on Quality of Life, Work Productivity, and Biomarkers in Adult Migraineurs: The Migraceutics® START Study
Migraine, Migraine Disease
RecruitingObservational study
Fremanezumab for the Prevention of Menstrually-related Migraine Attacks
Menstrual Migraine
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.
Pierre CLAVELOU contact
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 Menstrual Migraine, run by University Hospital, Clermont-Ferrand 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 4 inclusion and 9 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 15 May 2017. 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?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial pressure variations (time frame: during menstrual migraine attacks). 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 15 May 2017.