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NCT Number: NCT06503848

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location status: Recruiting

Location contact

Marta Torres-Ferrús, PhD

CONTACT

[email protected]

(+34)934893000 ext. 2479

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sumatriptan

Drug

Register the response to treatment and headache characteristics.

Primary outcomes

  1. Response to sumatriptan

    Time frame: 24 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 outcomes

  1. Migraine characteristics

    Time frame: 24 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marta Torres-Ferrús, PhD

CONTACT

[email protected]

(+34)934893000 ext. 2479

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Acronym: MAMBO

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 16, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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