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

NCT06503848 | Recruiting

• 1 other identifier: EOM(AG)053/2022(6055)
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Disorders

Keywords

migraine; triptan

Outcome Measures

Primary Outcomes (1)

• Response to sumatriptan

  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.

  24 hours

Secondary Outcomes (1)

• Migraine characteristics

  24 hours

Study Arms (1)

episodic migraine

Patients 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.

Drug: Sumatriptan

Interventions

Sumatriptan DRUG

Register the response to treatment and headache characteristics.

episodic migraine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Otherwise healthy episodic migraine patients.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Interventions

Sumatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Marta Torres-Ferrús, PhD

  Hospital Universitari Vall d'Hebron, Headache & Neurological Pain Research Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Torres-Ferrús, PhD

CONTACT

(+34)934893000; cefalea@vhir.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 16, 2024
• Study Start: January 25, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-08

Locations

ES (1)