Migraine Clinical Trial
Official title:
Provoked Migraine Attacks With Calcitonin Gene-related Peptide (CGRP) in Patients Who Have Tried Preventive Treatment With Anti-CGRP Monoclonal Antibodies.
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | September 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Danish Headache Center, Rigshospitalet Glostrup | Copenhagen | Glostrup |
Lead Sponsor | Collaborator |
---|---|
Danish Headache Center |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of migraine | Incidence of migraine after CGRP infusion | From 0 to 12 hours after CGRP infusion | |
Primary | 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 | |
Secondary | Heart rate | Heart rate (beats per minute) | From 0 to 90 minutes after infusion | |
Secondary | Blood pressure | Blood pressure (millimeter of mercury) | From 0 to 90 minutes after infusion |
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