Migraine
Conditions
Keywords
Calcitonin gene-related peptide
Brief summary
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.
Detailed description
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.
Interventions
Calcitonin gene-related peptide intravenous infusion (1.5 micrograms/min for 20 mins)
OTHERPlacebo
Isotonic saline
Sponsors
Danish Headache Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind study.
Intervention model description
Placebo-controlled, crossover design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of migraine according to the international classification of headache disorders version 3-beta * Subject has tried anti-CGRP antibodies for migraine * Women of childbearing potential are on safe contraception
Exclusion criteria
* Women of childbearing potential who do not use contraception. Includes non-hysterectomized women who have not been menopausal for at least two years. Safe contraception includes condoms, intrauterine devices, p-pills, surgical sterilization or gestagen injections. * Daily drug intake apart from contraceptives and preventive medication for migraine. * Ingestion of any drug 4 half-lifes before study start apart from contraceptives. * Pregnant or breast-feeding women * Migraine on the study day or less than 48 hours before CGRP infusion. * A history of cardiovascular and/or cerebrovascular disease * Systolic blood pressure \>150 mmHg and/or diastolic blood pressure \> 100 mmHg on study day. * Systolic blood pressure \<90 mmHg and/or diastolic blood pressure \< 50 mmHg on study day. * A history of mental illness * A history of any illness or condition that is deemed relevant for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of migraine | From 0 to 12 hours after CGRP infusion | Incidence of migraine after CGRP infusion |
| Area under the curve of headache intensity | From 0 to 90 minutes after infusion and from 90 minutes to 12 hours after infusion | Area under the curve of headache intensity from 0-90 min and 90 min-12 hours post infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | From 0 to 90 minutes after infusion | Heart rate (beats per minute) |
| Blood pressure | From 0 to 90 minutes after infusion | Blood pressure (millimeter of mercury) |
Countries
Denmark
Contacts
Primary ContactCasper E Christensen, MD
Backup ContactSamaira Younis, MD
Outcome results
None listed