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

This study is currently recruiting participants.
Verified August 2017 by Marie Deen Christensen, Danish Headache Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02309606
First Posted: December 5, 2014
Last Update Posted: August 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Marie Deen Christensen, Danish Headache Center
  Purpose
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.

Condition Intervention
Migraine Without Aura Other: PET scan with 5-HT receptor ligands

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Investigation of Serotonin Receptor Binding in the Migraine Brain Using Positron Emission Tomography

Resource links provided by NLM:


Further study details as provided by Marie Deen Christensen, Danish Headache Center:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 48
Study Start Date: December 2014
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Migraine without aura
Migraine patients suffering from migraine 0-4 days per month.
Other: 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.
Healthy controls
Healthy controls with no history of migraine or other primary headaches.
Other: 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.
Chronic migraine
Migraine patients with chronic migraine
Other: 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.

  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Migraine patients and healthy controls.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309606


Contacts
Contact: Marie Deen Christensen, MD 004521175085 marie.deen.christensen@regionh.dk

Locations
Denmark
Danish Headache Center, Glostrup Hospital Recruiting
Glostrup, Copenhagen, Denmark, 2600
Contact: Marie Deen Christensen, MD    004521175085    marie.deen.christensen@regionh.dk   
Sponsors and Collaborators
Danish Headache Center
  More Information

Responsible Party: Marie Deen Christensen, Medical Doctor, Danish Headache Center
ClinicalTrials.gov Identifier: NCT02309606     History of Changes
Other Study ID Numbers: H-6-2014-057
First Submitted: December 2, 2014
First Posted: December 5, 2014
Last Update Posted: August 16, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Migraine Disorders
Migraine without Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Serotonin
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs