An interventional study of Calcitonin Gene-Related Peptide and Placebo in Migraine, sponsored by Danish Headache Center. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-03-29.
Sponsored by Danish Headache Center · Not applicable, Interventional, and Other
The investigators aim to investigate the incidence of migraine attacks after calcitonin gene-related peptide (CGRP) infusion in patients who have tried anti-CGRP monoclonal antibody treatment for the prevention of migraine.
Calcitonin gene-related peptide (CGRP) plays a role in migraine pathophysiology. Infusions of CGRP can trigger migraine-like attacks in migraine patients and antibodies against CGRP or the CGRP receptor significantly reduces the number of migraine days per month when administered regularly. Some patients however, do not experience migraine attack after CGRP infusion, and some do not experience migraine reduction with antibodies. The underlying mechanisms of these effects are largely unknown.
The purpose of this study is to examine CGRP-induced migraine in patients who have evaluated the efficacy of anti-CGRP monoclonal antibody treatment for migraine using a purpose-developed standardized interview. The investigators will use a double-blind, placebo-controlled crossover study design to examine migraine susceptibility to CGRP in these patients.
Exclusion Criteria:
Calcitonin gene-related peptide infusion (1.5 micrograms/min for 20 mins)
Drug: Calcitonin Gene-Related Peptide
Infusion with placebo (isotonic saline)
Other: Placebo
Calcitonin gene-related peptide intravenous infusion (1.5 micrograms/min for 20 mins)
Also known as: CGRP
Isotonic saline
Incidence of migraine
Incidence of migraine after CGRP infusion
Time frame: From 0 to 12 hours after CGRP infusion
Area under the curve of headache intensity
Area under the curve of headache intensity from 0-90 min and 90 min-12 hours post infusion
Time frame: From 0 to 90 minutes after infusion and from 90 minutes to 12 hours after infusion
Heart rate
Heart rate (beats per minute)
Time frame: From 0 to 90 minutes after infusion
Blood pressure
Blood pressure (millimeter of mercury)
Time frame: From 0 to 90 minutes after infusion
Plan to share: No
This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Danish Headache Center