Migraine DisordersMAMBONCT06503848
Migraine Attack Treatment Response Molecular and Clinical BiOmarkers (MAMBO) Phase I
An observational study of Migraine Disorders, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Sumatriptan
- How many people
- 108 participants
- Where
- 1 siteSpain
- Study dates
- 25 Jan 2024to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Otherwise healthy episodic migraine patients.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona
Marta Torres-Ferrús, PhD, (+34)934893000 ext. 2479, cefalea@vhir.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Migraine Disorders
- Being tested
- Sumatriptan
- Keywords
- migraine, triptan
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SumatriptanDrug
Register the response to treatment and headache characteristics.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sumatriptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (1)
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start25 Jan 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Marta Torres-Ferrús, PhD, Principal investigator, Hospital Universitari Vall d'Hebron, Headache & Neurological Pain Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503848
- Sponsor's protocol ID
- EOM(AG)053/2022(6055)
- Acronym
- MAMBO
- Status last verified
- Aug 2024
- First submitted
- 10 Jul 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migraine Attack Treatment Response Molecular and Clinical BiOmarkers (The MAMBO Study) Phase I
- ClinicalTrials.gov ID
- NCT06503848
- Acronym / sponsor ID
- MAMBO / EOM(AG)053/2022(6055)
- Conditions
- Migraine Disorders
- Keywords
- migraine, triptan
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| episodic migraine | – | Drug: SumatriptanPatients 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Otherwise healthy episodic migraine patients.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SumatriptanRegister the response to treatment and headache characteristics. | Drug | episodic migraine |
Primary outcome
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.
1 secondary outcome
Migraine characteristics
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Torres-Ferrús, PhD principal investigator
Hospital Universitari Vall d'Hebron, Headache & Neurological Pain Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disorders, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta Torres-Ferrús, PhD ((+34)934893000 ext. 2479, cefalea@vhir.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to sumatriptan (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.