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

NCT ID: NCT06503848

Last Updated: 2024-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-25

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Migraine Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Sumatriptan

Intervention Type DRUG

Register the response to treatment and headache characteristics.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sumatriptan

Register the response to treatment and headache characteristics.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marta Torres-Ferrús, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marta Torres-Ferrús, PhD

Role: CONTACT

(+34)934893000 ext. 2479

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Marta Torres-Ferrús, PhD

Role: primary

(+34)934893000 ext. 2479

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EOM(AG)053/2022(6055)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.