Intracranial Pressure During Migraine
MigICP
Measure of Intracranial Pressure Variations During Migraine Attacks
2 other identifiers
observational
60
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2014
Longer than P75 for all trials
1 active site
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
July 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 11, 2017
CompletedFirst Posted
Study publicly available on registry
May 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedMay 15, 2017
May 1, 2017
2.8 years
May 11, 2017
May 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intracranial pressure variations
Measured during menstrual migraine attacks compared to ICP in non-migraine days and in matched healthy women
during menstrual migraine attacks
Secondary Outcomes (2)
Relationships between ICP variations and clinical parameters
during menstrual migraine attacks
Relationships between ICP variations and pain relief
during menstrual migraine attacks
Study Arms (2)
Women with menstrual migraine
Womens presenting with regular menstrual migraine treated with triptans will be included in the study.
Matched control
The potential variations will be compared to the measures done on matched healthy women outside and during menses.
Interventions
Self-measure of ICP will be performed outside and during menstrual migraine attacks.
Eligibility Criteria
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.
You may qualify if:
- to 50 non menopausal women
- Menstrual migraine
- Using a triptan as usual treatment to relieve attacks
- Usual triptan efficacy although recurrence is possible
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2017
First Posted
May 15, 2017
Study Start
July 21, 2014
Primary Completion
May 1, 2017
Study Completion
July 1, 2018
Last Updated
May 15, 2017
Record last verified: 2017-05