MigraineNCT02468622
Transcriptomic and Biochemical Changes During a Migraine Attack
An observational study of Migraine, run by Danish Headache Center at 1 site in Denmark.
Trial summary
Despite the fact that migraine is a common disorder, the pathogenesis is still not fully elucidated. Studying transcriptomic and biochemical changes during induced and spontaneous migraine-attacks will enhance our understanding and may point to new targets for drug development. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Migraine
- What is being tested?
- Blood samples
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2015to Jun 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 15 patients with migraine without aura and 15 paitients with migraine with aura
Who may be able to join
- Migraine patients who meet IHS criteria for migraine with or without aura of both sexes,
- 18-70 years,
- 45-95 kg.
Who cannot join
- any other type of headache then migraine without aura (except episodic tension-type headache < 1 day per week),
- serious somatic or psychiatric disease,
- pregnancy,
- and intake of daily medication (except oral contraceptives).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcriptomic and Biochemical Changes During Spontaneous Attacks of Migraine With Aura and Migraine Without Aura
Despite the fact that migraine is a common disorder, the pathogenesis is still not fully elucidated. Studying transcriptomic and biochemical changes during induced and spontaneous migraine-attacks will enhance our understanding and may point to new targets for drug development.
Read the detailed description
Migraine is a common neurological disorder affecting approx. 16 % of the European population. Despite the fact that migraine is a common disorder, the pathogenesis is still not sufficiently known.
Studying transcriptomic and biochemical changes during spontaneous migraine-attacks will greatly enhance our understanding of migraine mechanisms and may point to new targets for drug development.
Two blood samples (one for RNA analysis and one for biochemical analysis) are taken on minimum 15 patient with migraine with aura and 15 patients with migraine without aura when they experience a spontaneous migraine attack. A second sample is taken 2 hours after treatment with subcutaneous sumatriptan. Another two blood samples are taken when the patient has been migraine free for at least 5 days and had no other headache for at least 24 hours. A fourth set of blood samples are collected after a cold pressor test.
- Conditions
- Migraine
- Being tested
- Blood samples
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
There is no intervention, but we will take blood samples during a spontaneous migraine attack
| Study group | Role | What they receive |
|---|---|---|
| MO patients | Patients with migraine without aura. We will take blood samples during spontaneous migraine attacks Receives: Other: Blood samples | |
| MA patients | Patients with migraine with aura. We will take blood samples during spontaneous migraine attacks Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcriptomic changes
The investigators will measure transcriptomic changes using Next Generation Sequencing during a migraine attack
Measured: 2 year
Changes in CGRP levels during a migraine attack (CGRP1-37, CGRP1-17, CGRP18-37, CGRP1-26, CGRP27-37)
The investigators will use advanced mass spectrometry to measure CGRP levels
Measured: 2 year
Changes in PACAP levels during a migraine attack (PACAP-27, PACAP-38 )
The investigators will use advanced mass spectrometry to measure PACAP levels
Measured: 2 years
Changes in VIP, glutamate, serotonin, PGE-2, nitric oxide metabolites, cAMP, and cGMP
The investigators will use advanced mass spectrometry to measure VIP, glutamate, serotonin, PGE-2, nitric oxide metabolites, cAMP, and cGMP during a migraine attack
Measured: 2 years
Changes in Metabolomics
The investigators will use advanced mass spectrometry (LC-MS) to measure metabolomics in the 4 blood samples
Measured: 3 years
Changes in Proteomics
The investigators will use advanced mass spectrometry to measure proteomics in the 4 blood samples
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2016
- Study completionJun 2016
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.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katrine Falkenberg, Danish Headache Center
- Investigators
- Emma Katrine Hansen, Doctor, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468622
- Sponsor's protocol ID
- Transcriptomics
- Status last verified
- Dec 2019
- First submitted
- 4 Jun 2015
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcriptomic and Biochemical Changes During Spontaneous Attacks of Migraine With Aura and Migraine Without Aura
- ClinicalTrials.gov ID
- NCT02468622
- Acronym / sponsor ID
- Transcriptomics
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 11 Jun 2015 (estimated)
- 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.
Despite the fact that migraine is a common disorder, the pathogenesis is still not fully elucidated. Studying transcriptomic and biochemical changes during induced and spontaneous migraine-attacks will enhance our understanding and may point to new targets for drug development.
Detailed description
Migraine is a common neurological disorder affecting approx. 16 % of the European population. Despite the fact that migraine is a common disorder, the pathogenesis is still not sufficiently known.
Studying transcriptomic and biochemical changes during spontaneous migraine-attacks will greatly enhance our understanding of migraine mechanisms and may point to new targets for drug development.
Two blood samples (one for RNA analysis and one for biochemical analysis) are taken on minimum 15 patient with migraine with aura and 15 patients with migraine without aura when they experience a spontaneous migraine attack. A second sample is taken 2 hours after treatment with subcutaneous sumatriptan. Another two blood samples are taken when the patient has been migraine free for at least 5 days and had no other headache for at least 24 hours. A fourth set of blood samples are collected after a cold pressor test.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MO patients | – | Other: Blood samplesPatients with migraine without aura. We will take blood samples during spontaneous migraine attacks |
| MA patients | – | Other: Blood samplesPatients with migraine with aura. We will take blood samples during spontaneous migraine attacks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 15 patients with migraine without aura and 15 paitients with migraine with aura
Key inclusion criteria (3 listed)
- Migraine patients who meet IHS criteria for migraine with or without aura of both sexes,
- 18-70 years,
- 45-95 kg.
Key exclusion criteria (4 listed)
- any other type of headache then migraine without aura (except episodic tension-type headache < 1 day per week),
- serious somatic or psychiatric disease,
- pregnancy,
- and intake of daily medication (except oral contraceptives).
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 |
|---|---|---|
| Blood samplesThere is no intervention, but we will take blood samples during a spontaneous migraine attack | Other | MA patients, MO patients |
Primary outcome
Transcriptomic changes
Time frame: 2 year
The investigators will measure transcriptomic changes using Next Generation Sequencing during a migraine attack
Changes in CGRP levels during a migraine attack (CGRP1-37, CGRP1-17, CGRP18-37, CGRP1-26, CGRP27-37)
Time frame: 2 year
The investigators will use advanced mass spectrometry to measure CGRP levels
Changes in PACAP levels during a migraine attack (PACAP-27, PACAP-38 )
Time frame: 2 years
The investigators will use advanced mass spectrometry to measure PACAP levels
Changes in VIP, glutamate, serotonin, PGE-2, nitric oxide metabolites, cAMP, and cGMP
Time frame: 2 years
The investigators will use advanced mass spectrometry to measure VIP, glutamate, serotonin, PGE-2, nitric oxide metabolites, cAMP, and cGMP during a migraine attack
Changes in Metabolomics
Time frame: 3 years
The investigators will use advanced mass spectrometry (LC-MS) to measure metabolomics in the 4 blood samples
Changes in Proteomics
Time frame: 3 years
The investigators will use advanced mass spectrometry to measure proteomics in the 4 blood samples
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
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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.
Emma Katrine Hansen, Doctor principal investigator
Danish Headache Center
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, run by Danish Headache Center at 1 site in Denmark.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 16 Dec 2019. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcriptomic changes (time frame: 2 year). The study lists 6 primary outcomes in all. 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 16 Dec 2019.