Adrenomedullin Effect on Migraine Without Patients
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|ClinicalTrials.gov Identifier: NCT04111484|
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : March 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Headache, Migraine||Other: Adrenomedullin Other: Saline||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Study participants and investigator will be blinded.|
|Official Title:||Adrenomedullins Headache Inducing Effects on Migraine Without Patients|
|Actual Study Start Date :||September 28, 2019|
|Actual Primary Completion Date :||January 30, 2020|
|Actual Study Completion Date :||January 30, 2020|
Active Comparator: Adrenomedullin
Will received 19.9 picomol/kg/min of adrenomedullin over 20 min
Adrenomedullin is a naturally found in the human body and has strong vasoactive properties.
Placebo Comparator: Saline
- Migraine incidance after infusion of adrenomedullin compared to placebo [ Time Frame: 0-12 hours ]A standard headache questionnaire will be used to register headache intensity and migraine associated symptoms.
- Headache intensity [ Time Frame: 0-12 hours ]Headache intensity will be measured using Visual analogue scale (0 = no pain -10 = worst pain )
- Change in puls, MAP and facial flushing [ Time Frame: 0-90 minutes ]After infusion of adrenomedullin compared to placebo
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): NCT04111484
|Danish Headache Center|
|Glostrup, Denmark, 2600|