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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcitonin gene-related peptide | Experimental | Calcitonin gene-related peptide infusion (1.5 micrograms/min for 20 mins) |
|
| Placebo | Experimental | Infusion with placebo (isotonic saline) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcitonin Gene-Related Peptide | Drug | Calcitonin gene-related peptide intravenous infusion (1.5 micrograms/min for 20 mins) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of migraine | Incidence of migraine after CGRP infusion | 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 | From 0 to 90 minutes after infusion and from 90 minutes to 12 hours after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | Heart rate (beats per minute) | From 0 to 90 minutes after infusion |
| Blood pressure | Blood pressure (millimeter of mercury) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Casper E Christensen, MD | Contact | 38632027 | casper.emil.christensen.03@regionh.dk | |
| Samaira Younis, MD | Contact | 38632176 | samaira.younis.01@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Messoud Ashina, prof. | Danish Headache Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Headache Center, Rigshospitalet Glostrup | Recruiting | Copenhagen | Glostrup | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30409109 | Derived | Christensen CE, Younis S, Deen M, Khan S, Ghanizada H, Ashina M. Migraine induction with calcitonin gene-related peptide in patients from erenumab trials. J Headache Pain. 2018 Nov 8;19(1):105. doi: 10.1186/s10194-018-0927-2. |
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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 |
|---|---|
| D015740 | Calcitonin Gene-Related Peptide |
| ID | Term |
|---|---|
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
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Placebo-controlled, crossover design.
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Double-blind study.
| Placebo | Other | Isotonic saline |
|
| From 0 to 90 minutes after infusion |
| D009422 | Nervous System Diseases |
| D011506 |
| Proteins |