Investigation of Serotonin Receptor Binding in the Migraine Brain Using Positron Emission Tomography

NCT ID: NCT02309606

Last Updated: 2018-01-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 56 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-12-31

Brief 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. 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Migraine without aura

Migraine patients suffering from migraine 0-4 days per month.

PET scan with 5-HT receptor ligands

Intervention Type: OTHER

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.

Healthy controls

Healthy controls with no history of migraine or other primary headaches.

PET scan with 5-HT receptor ligands

Intervention Type: OTHER

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.

Chronic migraine

Migraine patients with chronic migraine

PET scan with 5-HT receptor ligands

Intervention Type: OTHER

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.

Interventions

PET scan with 5-HT receptor ligands

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Written informed consent

• Migraine without aura according to the International Headache Society (IHS) 0-4 days per month
• The migraine is treatable with sumatriptan

• Do not suffer from migraine according to IHS
• Do not have any first degree relatives with migraine

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Danish Headache Center

OTHER

Sponsor Role: lead

Responsible Party

Marie Deen Christensen

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Danish Headache Center, Glostrup Hospital

Glostrup, Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

H-6-2014-057

Identifier Type: -

Identifier Source: org_study_id