Migraine Attack Treatment Response Molecular and Clinical BiOmarkers (MAMBO) Phase I
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sumatriptan.
- Who it may be relevant to
- Registry conditions: Migraine Disorders. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Migraine Attack Treatment Response Molecular and Clinical BiOmarkers (The MAMBO Study) Phase I
Overview
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.
Interventions
- Drug Sumatriptan
Register the response to treatment and headache characteristics.
Primary outcome measures
- Response to sumatriptan [Time frame: 24 hours]
Secondary outcome measures (1)
- Migraine characteristics [Time frame: 24 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Spain · 1 center
- Hospital Universitari Vall d'Hebron — Barcelona
Identifiers
NCT: NCT06503848 · EOM(AG)053/2022(6055)