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NCT Number: NCT02309606

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

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.

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Key information

Conditions

Migraine Without Aura Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Danish Headache Center, Glostrup Hospital

Glostrup, Copenhagen, 2600, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

, both groups:

  • Written informed consent

Inclusion criteria

, episodic migraine patients:

  • 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

Inclusion criteria

, healthy controls:

  • 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.

Treatment and study plan

PET scan with 5-HT receptor ligands

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 5, 2014
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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