Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2019-09-28
2020-01-30
Brief Summary
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Detailed Description
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A pilot study on healthy volunteers were conducted to determine tolerable dose of adrenomedullin to the main study.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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Adrenomedullin
Will received 19.9 picomol/kg/min of adrenomedullin over 20 min
Adrenomedullin
Adrenomedullin is a naturally found in the human body and has strong vasoactive properties.
Saline
Saline
Saline
Placebo
Interventions
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Adrenomedullin
Adrenomedullin is a naturally found in the human body and has strong vasoactive properties.
Saline
Placebo
Eligibility Criteria
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Inclusion Criteria
* 50-100 kg
* migraine without aura according International Headache Classification Disorders 3rd edition
Exclusion Criteria
* All other primary headache forms.-
* Headache later than 48 hours before the start of the trial.
* Daily intake of medicines of all kinds except oral contraception.
* Taking any medicine later than 4 times the plasma half-life of that drug (on the day of the trial), except oral contraception.
* Pregnant or breastfeeding women.
* Headache on the day of the trial or later than 48 hours before the administration of the trial drug / placebo
* Migraines within 3 days before the trial date.
* Anamnestic information or clinical signs (on the day of inclusion):
* Hypertension (systolic blood pressure\> 150 mmHg and / or diastolic blood pressure\> 100 mmHg)
* Hypotension (systolic blood pressure \<90 mm Hg and / or diastolic blood pressure \<50 mmHg)
* Cardiovascular diseases of all kinds, including cerebrovascular diseases.
* Anamnestic or clinical signs of mental illness or abuse.
* Patients with glaucoma or prostate hyperplasia
* Anamnestic or clinical signs of illness of any kind that the investigating physician considers relevant for participation in the trial.
18 Years
60 Years
ALL
No
Sponsors
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Danish Headache Center
OTHER
Responsible Party
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Hashmat Ghanizada, MD
MD, PhD-Fellow
Locations
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Danish Headache Center
Glostrup Municipality, , Denmark
Countries
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References
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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.
Other Identifiers
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H-18020494
Identifier Type: -
Identifier Source: org_study_id
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