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Migraine Attack Treatment Response Molecular and Clinical BiOmarkers (MAMBO) Phase I

Recruiting
Conditions
Migraine Disorders
Interventions
Registration Number
NCT06503848
Lead Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Brief Summary

The goal of this observational study is to identify differential traits in spontaneous migraine attacks that can help us predict the response to treatment with sumatriptan.

Participants will be asked to register the headache characteristics before and after taking sumatriptan and whether the treatment was effective or not during four migraine attacks.

Detailed Description

There is still an unmet need in acute migraine treatment, some patients don't respond properly to acute medication.

There are some interindividual differences in clinical characteristics of migraine attacks. These differences may determine the response to acute treatment. Describing the phenotypical differences between patients who are responders and patients non-responders will allow us to offer a personalized treatment.

The aim of the study is to determine which characteristics are associated with a response or a non-response to acute treatment with sumatriptan.

Participants will be asked to register the headache characteristics and accompanying symptoms during 4 spontaneous migraine attacks and its response to treatment with sumatriptan.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
108
Inclusion Criteria
  • Migraine with or without aura diagnosis according to ICHD-3 criteria
  • <8 migraine days per month
  • Be able to read, write and understand instructions.
  • Have internet access and mail address
  • Signing of the informed consent
Exclusion Criteria
  • Active preventive treatment for migraine
  • Active medication with an effect over the central nervous system
  • Serious physical or psychiatric condition
  • Cardiovascular or hepatic disease
  • Pregnant or breastfeeding women
  • Any triptan contraindication
  • Severe migraine attacks without previous response to triptans or NSAIDs

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
episodic migraineSumatriptanPatients with episodic migraine will be asked to treat four spontaneous migraine attacks with sumatriptan 50 milligrams. They will register the headache characteristics and whether or not the treatment was effective.
Primary Outcome Measures
NameTimeMethod
Response to sumatriptan24 hours

Relief of pain from moderate-severe to mild or absent at 2 hours and 24 hours in 3 out of 4 migraine attacks.

The response will be evaluated via questionnaire.

Secondary Outcome Measures
NameTimeMethod
Migraine characteristics24 hours

Patients will complete a questionnaire describing the characteristics of migraine attacks in the beginning of the attack, and at timepoints 2 and 24 hours after taking sumatriptan.

Trial Locations

Locations (1)

Hospital Universitari Vall d'Hebron

🇪🇸

Barcelona, Spain

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