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

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

Study Overview

• Status: Recruiting
• Conditions: Migraine Disorders
• Intervention / Treatment: Drug: Sumatriptan

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.

• Study Type: Observational
• Enrollment (Estimated): 108

Contacts and Locations

• Study Contact: Name: Marta Torres-Ferrús, PhD; Phone Number: 2479 (+34)934893000; Email: cefalea@vhir.org

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Universitari Vall d'Hebron
    • Contact: Marta Torres-Ferrús, PhD; Phone Number: 2479 (+34)934893000; Email: cefalea@vhir.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Otherwise healthy episodic migraine patients.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Register the response to treatment and headache characteristics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migraine characteristics	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.	24 hours

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Collaborators: Instituto de Salud Carlos III
• Investigators: Principal Investigator: Marta Torres-Ferrús, PhD, Hospital Universitari Vall d'Hebron, Headache & Neurological Pain Research Group

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: migraine; triptan
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Vasoconstrictor Agents; Serotonin Receptor Agonists; Serotonin 5-HT1 Receptor Agonists; Sumatriptan
• Other Study ID Numbers: EOM(AG)053/2022(6055)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No