Status:
UNKNOWN
CGRP-induced Migraine Attacks in Patients Who Have Tried Anti-CGRP Monoclonal Antibody Treatment
Lead Sponsor:
Danish Headache Center
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
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 recept...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03481400
Start Date
July 1 2016
End Date
September 1 2019
Last Update
March 29 2018
Active Locations (1)
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1
Danish Headache Center, Rigshospitalet Glostrup
Copenhagen, Glostrup, Denmark, 2600