MigraineNCT04356079
Familial and Environmental Factors Behind Migraine
An observational study of Migraine, run by Assiut University.
Trial summary
Migraine is a chronic neurological disease characterized by recurrent moderate to severe headaches often in association with a number of autonomic nervous system symptoms. Migraines are believed to be due to a mixture of environmental and genetic factors. About two-thirds of cases run in families. Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Migraine
- What is being tested?
- International Headache Society Test
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to Aug 2020
- 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 15 to 45 years
- All sexes
- Child, Adult
Study population: Patients suffering from Headache between 15 and 45 years old
Who may be able to join
- Fullfilled Migraine chriteria
Who cannot join
- Genereal Neurologic Disease
Trial locations and contacts
No sites are listed yet.
About this study
Migraine is a chronic neurological disease characterized by recurrent moderate to severe headaches often in association with a number of autonomic nervous system symptoms. Migraines are believed to be due to a mixture of environmental and genetic factors. About two-thirds of cases run in families. Changing hormone levels may also play a role, as migraines affect slightly more boys than girls before puberty, but about two to three times more women than men after puberty. The risk of migraines usually decreases during pregnancy. The exact mechanisms of migraine are not known. It is, however, believed to be a neurovascular disorder. The primary theory is related to increased excitability of the cerebral cortex and abnormal control of pain neurons in the trigeminal nucleus of the brainstem.
Read the detailed description
Environmental influences play a role, but family studies suggest that defective genes may be primarily involved in disease causation. The mode of transmission of typical migraine in families is still unclear, but it is widely believed to be multifactorial although a role for a major susceptibility gene cannot be excluded. Aim of study: we aim to study the familial risk for developed migraine and its relation to EEG changes.
- Conditions
- Migraine
- Being tested
- International Headache Society Test
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
International Headache Society TestDiagnostic test
Also called Family Pedigree Chart
Thorough History of Patients and families
| Study group | Role | What they receive |
|---|---|---|
| Migraine patients | Not described Receives: Diagnostic Test: International Headache Society Test | |
| Control | Not described Receives: Diagnostic Test: International Headache Society Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of risk factors for migraine
Familial History
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study startApr 2020 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Family based
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Mohamed Aly Tohamy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356079
- Sponsor's protocol ID
- FEFM
- Status last verified
- Apr 2020
- First submitted
- 18 Apr 2020
- Last updated
- 22 Apr 2020
- 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 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Familial and Environmental Factors Behind Migraine
- ClinicalTrials.gov ID
- NCT04356079
- Acronym / sponsor ID
- FEFM
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 22 Apr 2020 (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.
Migraine is a chronic neurological disease characterized by recurrent moderate to severe headaches often in association with a number of autonomic nervous system symptoms. Migraines are believed to be due to a mixture of environmental and genetic factors. About two-thirds of cases run in families. Changing hormone levels may also play a role, as migraines affect slightly more boys than girls before puberty, but about two to three times more women than men after puberty. The risk of migraines usually decreases during pregnancy. The exact mechanisms of migraine are not known. It is, however, believed to be a neurovascular disorder. The primary theory is related to increased excitability of the cerebral cortex and abnormal control of pain neurons in the trigeminal nucleus of the brainstem.
Detailed description
Environmental influences play a role, but family studies suggest that defective genes may be primarily involved in disease causation. The mode of transmission of typical migraine in families is still unclear, but it is widely believed to be multifactorial although a role for a major susceptibility gene cannot be excluded. Aim of study: we aim to study the familial risk for developed migraine and its relation to EEG changes.
Study design
- Observational model
- Family based
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Migraine patients | – | Diagnostic Test: International Headache Society Test |
| Control | – | Diagnostic Test: International Headache Society Test |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients suffering from Headache between 15 and 45 years old
Key inclusion criteria (1 listed)
- Fullfilled Migraine chriteria
Key exclusion criteria (1 listed)
- Genereal Neurologic Disease
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 |
|---|---|---|
| International Headache Society TestAlso: Family Pedigree ChartThorough History of Patients and families | Diagnostic test | Control, Migraine patients |
Primary outcome
Diagnosis of risk factors for migraine
Time frame: 6 months
Familial History
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Assiut University.
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 1 inclusion and 1 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 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Amal Tohamy, MD (00201221783835, tohamy.amal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of risk factors for migraine (time frame: 6 months). 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 22 Apr 2020.