Migraine Without AuraNCT02309606
Investigation of Serotonin Receptor Binding in the Migraine Brain Using Positron Emission Tomography
An observational study of Migraine Without Aura, run by Danish Headache Center at 1 site in Denmark.
Trial summary
Migraine affects 16% of the world population and is one of the most disabling of all disorders. It is a complex brain disorder characterized primarily by recurrent headache attacks. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Without Aura
- What is being tested?
- PET scan with 5-HT receptor ligands
- How many people
- 56 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2015to Dec 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Migraine patients and healthy controls.
Who may be able to join
- Written informed consent
- Migraine without aura according to the International Headache Society (IHS) 0-4 days per month
- The migraine is treatable with sumatriptan
- Inclusion Criteria, chronic migraine patients: Fulfill IHS criteria for chronic migraine
- Do not suffer from migraine according to IHS
- Do not have any first degree relatives with migraine
Who cannot join
- Tension type headache more than 5 days per month during the last year.
- Tension type headache on the experimental day.
- Any other primary headache disorder
- Migraine 48 hour before and after the experimental day (only episodic migraine patients)
- Use of antimigraine medication or pain-killer on the experimental day before PET
- Pregnant or breastfeeding women.
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- Contraindications against MRI.
- History or clinical sign of cardio- or cerebrovascular disease.
- Untreated severe mental disorder or drug abuse.
- Other diseases or disorders interpreted, by the examining doctor, to interfere with participation in the study.
- Not accepting information about potential accidental findings during the experiment.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Headache Center, Glostrup Hospital
Glostrup, Copenhagen, 2600
About this study
Migraine affects 16% of the world population and is one of the most disabling of all disorders. It is a complex brain disorder characterized primarily by recurrent headache attacks. The signaling molecule serotonin (5-hydroxytryptamine, 5-HT) has for decades been thought to play a central role in migraine pathophysiology. The most effective class of abortive migraine drugs, the triptans, act on 5-HT receptors. However, the migraine-specific actions of serotonin and the mechanisms of triptans are still unknown. In this project the investigators will use high-resolution positron emission tomography and specific radioligands to investigate the significance of serotonin in migraine. Two newly developed radioligands that are specific for the 5-HT1B and 5-HT4 receptor, respectively, will be applied. To investigate the level and distribution of serotonin in the migraine brain the investigators will compare the binding of these ligands in episodic migraine patients with healthy controls. In addition, the investigators will include chronic migraine patients to evaluate the relation between the level of serotonin in the brain and the frequency of migraine attacks. To investigate the changes in the serotonin level during a migraine attack and the effects of triptans on the central nervous system the investigators will repeat the scans using the 5-HT1B specific ligand during induced migraine attacks and following treatment with sumatriptan. The results from this study will shed light on the role of serotonin in the migraine brain and elucidate the migraine-specific action of triptans. This will improve our understanding of the migraine pathophysiology and, potentially, facilitate the development of more efficient treatment of migraine.
- Conditions
- Migraine Without Aura
- Being tested
- PET scan with 5-HT receptor ligands
- Medical subject headings
- Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET scan with 5-HT receptor ligandsOther
Interictal episodic migraine patients and healthy controls will be scanned with a 5-HT1B and a 5-HT4 receptor radioligand. Episodic migraine patients will further be scanned during a cilostazol induced migraine attack and after treatment with sumatriptan. Chronic migraine patients will be scanned with only the 5-HT4 receptor radioligand.
| Study group | Role | What they receive |
|---|---|---|
| Migraine without aura | Migraine patients suffering from migraine 0-4 days per month. Receives: Other: PET scan with 5-HT receptor ligands | |
| Healthy controls | Healthy controls with no history of migraine or other primary headaches. Receives: Other: PET scan with 5-HT receptor ligands | |
| Chronic migraine | Migraine patients with chronic migraine Receives: Other: PET scan with 5-HT receptor ligands |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in binding of the 5-HT1B radioligand
Differences in bindingpotentials for the 5-HT1B ligand between migraine patients and healthy controls will be assessed using the Simplified Reference Tissue Model.
Measured: Up to 1 year
Differences in binding of the 5-HT4 radioligand
Differences in bindingpotentials for the 5-HT4 ligand between migraine patients and healthy controls will be assessed using the Simplified Reference Tissue Model.
Measured: Up to 1 year
Differences in binding of the 5-HT4 radioligand
Differences in bindingpotentials for the 5-HT4 ligand between chronic migraine patients and healthy controls and between chronic and episodic migraine patients will be assessed using the Simplified Reference Tissue Model.
Measured: Up to 1 year
Correlation with migraine frequency and 5-HT4 receptor binding
Correlations between migraine days and 5-HT4 receptor binding will be investigated using pooled data from episodic and chronic migraine patients on migraine frequency and their 5-HT4 receptor binding potentials assessed using the simplified reference tissue model
Measured: Up to 1 year
Differences in binding of the 5-HT1B radioligand
Differences in binding between ictal and interictal binding and between ictal and post-treatment binding in episodic migraine patients will be assessed using the simplified reference tissue model
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionAug 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine Without AuraStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Deen Christensen, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309606
- Sponsor's protocol ID
- H-6-2014-057
- Status last verified
- Jan 2018
- First submitted
- 2 Dec 2014
- Last updated
- 31 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Serotonin Receptor Binding in the Migraine Brain Using Positron Emission Tomography
- ClinicalTrials.gov ID
- NCT02309606
- Acronym / sponsor ID
- H-6-2014-057
- Conditions
- Migraine Without Aura
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Dec 2014 (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.
Migraine affects 16% of the world population and is one of the most disabling of all disorders. It is a complex brain disorder characterized primarily by recurrent headache attacks. The signaling molecule serotonin (5-hydroxytryptamine, 5-HT) has for decades been thought to play a central role in migraine pathophysiology. The most effective class of abortive migraine drugs, the triptans, act on 5-HT receptors. However, the migraine-specific actions of serotonin and the mechanisms of triptans are still unknown. In this project the investigators will use high-resolution positron emission tomography and specific radioligands to investigate the significance of serotonin in migraine. Two newly developed radioligands that are specific for the 5-HT1B and 5-HT4 receptor, respectively, will be applied. To investigate the level and distribution of serotonin in the migraine brain the investigators will compare the binding of these ligands in episodic migraine patients with healthy controls. In addition, the investigators will include chronic migraine patients to evaluate the relation between the level of serotonin in the brain and the frequency of migraine attacks. To investigate the changes in the serotonin level during a migraine attack and the effects of triptans on the central nervous system the investigators will repeat the scans using the 5-HT1B specific ligand during induced migraine attacks and following treatment with sumatriptan. The results from this study will shed light on the role of serotonin in the migraine brain and elucidate the migraine-specific action of triptans. This will improve our understanding of the migraine pathophysiology and, potentially, facilitate the development of more efficient treatment of migraine.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Migraine without aura | – | Other: PET scan with 5-HT receptor ligandsMigraine patients suffering from migraine 0-4 days per month. |
| Healthy controls | – | Other: PET scan with 5-HT receptor ligandsHealthy controls with no history of migraine or other primary headaches. |
| Chronic migraine | – | Other: PET scan with 5-HT receptor ligandsMigraine patients with chronic migraine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Migraine patients and healthy controls.
Key inclusion criteria (6 listed)
- Written informed consent
- Migraine without aura according to the International Headache Society (IHS) 0-4 days per month
- The migraine is treatable with sumatriptan
- Inclusion Criteria, chronic migraine patients: Fulfill IHS criteria for chronic migraine
- Do not suffer from migraine according to IHS
Key exclusion criteria (11 listed)
- Tension type headache more than 5 days per month during the last year.
- Tension type headache on the experimental day.
- Any other primary headache disorder
- Migraine 48 hour before and after the experimental day (only episodic migraine patients)
- Use of antimigraine medication or pain-killer on the experimental day before PET
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 |
|---|---|---|
| PET scan with 5-HT receptor ligandsInterictal episodic migraine patients and healthy controls will be scanned with a 5-HT1B and a 5-HT4 receptor radioligand. Episodic migraine patients will further be scanned during a cilostazol induced migraine attack and after treatment with sumatriptan. Chronic migraine patients will be scanned with only the 5-HT4 receptor radioligand. | Other | Chronic migraine, Healthy controls, Migraine without aura |
Primary outcome
Differences in binding of the 5-HT1B radioligand
Time frame: Up to 1 year
Differences in bindingpotentials for the 5-HT1B ligand between migraine patients and healthy controls will be assessed using the Simplified Reference Tissue Model.
Differences in binding of the 5-HT4 radioligand
Time frame: Up to 1 year
Differences in bindingpotentials for the 5-HT4 ligand between migraine patients and healthy controls will be assessed using the Simplified Reference Tissue Model.
Differences in binding of the 5-HT4 radioligand
Time frame: Up to 1 year
Differences in bindingpotentials for the 5-HT4 ligand between chronic migraine patients and healthy controls and between chronic and episodic migraine patients will be assessed using the Simplified Reference Tissue Model.
Correlation with migraine frequency and 5-HT4 receptor binding
Time frame: Up to 1 year
Correlations between migraine days and 5-HT4 receptor binding will be investigated using pooled data from episodic and chronic migraine patients on migraine frequency and their 5-HT4 receptor binding potentials assessed using the simplified reference tissue model
Differences in binding of the 5-HT1B radioligand
Time frame: Up to 1 year
Differences in binding between ictal and interictal binding and between ictal and post-treatment binding in episodic migraine patients will be assessed using the simplified reference tissue model
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 31 Jan 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Without Aura, 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 6 inclusion and 11 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 31 Jan 2018. 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?
Differences in binding of the 5-HT1B radioligand (time frame: Up to 1 year). The study lists 5 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 31 Jan 2018.