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AM is a naturally occurring peptide in the body and consists of 52 amino acids. AM belongs to the calcitonin gene-related peptide (CGRP) superfamily and has several structural, physiological and pharmacological similarities to CGRP, intermdine and amylin. In a randomized double-blind, placebo controlled cross-over design 20 migraine patients without aura recruited to receive infusion of adrenomedullin or placebo (saline).
AM is a naturally occurring peptide in the body and consists of 52 amino acids. AM belongs to the calcitonin gene-related peptide (CGRP) superfamily and has several structural, physiological and pharmacological similarities to CGRP, intermdine and amylin. In a randomized double-blind, placebo controlled cross-over design 20 migraine patients without aura recruited to receive infusion of adrenomedullin or placebo (saline).
A pilot study on healthy volunteers were conducted to determine tolerable dose of adrenomedullin to the main study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adrenomedullin | Active Comparator | Will received 19.9 picomol/kg/min of adrenomedullin over 20 min |
|
| Saline | Placebo Comparator | Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adrenomedullin | Other | Adrenomedullin is a naturally found in the human body and has strong vasoactive properties. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Migraine incidance after infusion of adrenomedullin compared to placebo | A standard headache questionnaire will be used to register headache intensity and migraine associated symptoms. | 0-12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Headache intensity | Headache intensity will be measured using Visual analogue scale (0 = no pain -10 = worst pain ) | 0-12 hours |
| Change in puls, MAP and facial flushing | After infusion of adrenomedullin compared to placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Headache Center | Glostrup Municipality | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33827963 | Derived | Ghanizada H, Al-Karagholi MA, Arngrim N, Morch-Rasmussen M, Walker CS, Hay DL, Ashina M. Effect of Adrenomedullin on Migraine-Like Attacks in Patients With Migraine: A Randomized Crossover Study. Neurology. 2021 May 18;96(20):e2488-e2499. doi: 10.1212/WNL.0000000000011930. Epub 2021 Apr 7. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D053607 | Adrenomedullin |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
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Study participants and investigator will be blinded.
| Saline | Other | Placebo |
|
| 0-90 minutes |
| D009422 | Nervous System Diseases |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |