Headache Clinical Trial
Official title:
Structural and Functional Cerebral Changes After Infusion of ATP Sensitive Potassium Channel Opener Levcromakalim.
The aim of the present study to investigate whether - Opening of KATP channels causes migraine pain by activation of meningeal nociceptors and ascending trigeminal nociceptive pathways. - Opening of KATP channels causes migraine aura by induction of CSD.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | July 31, 2023 |
Est. primary completion date | July 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Migraine patients - 18-60 years. - 50-100 kg. - Women of childbearing potential must use adequate contraception. Exclusion Criteria: - A history of serious somatic disease - Any other type of headache (except episodic tension-type headache less than once a month) Daily intake of any medication except contraceptives Contraindications for MRI scan. |
Country | Name | City | State |
---|---|---|---|
Denmark | Danish headache center | Copenhagen | Glostrup |
Lead Sponsor | Collaborator |
---|---|
Danish Headache Center |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dynamic diffusion weighted image (DWI) | To measure transient diffusivity changes related to levcromakalim-induced CSD during the aura phase of migraine in subjects with migraine with aura. | Before and after infusion of levcromakalim compared with before and after infusion of saline. Time of measurements is baseline, 20 minutes and 160 minutes after the infusion. | |
Secondary | Vascular imaging before sumatriptan | To investigate the diameter of middle meningeal arteries (MMA), superficial temporal arteries (STA) and middle cerebral arteries (MCA) measured by millimeters (mm). | Before and after infusion of levcromakalim compared with before and after infusion of saline. Time of measurements is baseline, 20 minutes and 160 minutes after the infusion. | |
Secondary | Vascular imaging after sumatriptan | To investigate the diameter of middle meningeal arteries (MMA), superficial temporal arteries (STA) and middle cerebral arteries (MCA) measured by millimeters (mm). | Before and after infusion of sumatriptan. Time of measurements is 200 minutes and 210 minutes after the infusion. |
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