G43.0
Conditions
Interventions
Group 1: Women with migraine using continuous hormonal contraception.
Participants will receive an intravenous infusion of atosiban (6.75mg, equivalent to 0.9ml, as a bolus over 1 minute, followed by
Sponsors
Charité Universtitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Group 1: Women with migraine are eligible to be included in the study if all of the following criteria apply: 1. Confirmed episodic migraine based on the criteria of the IHS 2. 1-5 migraine days in the 28 days prior to study enrollment 3. Use of continuous hormonal contraception (i.e., no hormone-free interval) for at least 3 months 4. Age 18-45 years upon entry into screening. Control 1: Men with migraine are eligible to be included in the study if all of the following criteria apply: 1. Confirmed episodic migraine based on the criteria of the International Headache Society (IHS) 1. 1-5 migraine days in the 28 days prior to study enrollment 2. Age 18-45 years upon entry into screening. Control 2: Healthy female controls are eligible to be included in the study if all of the following criteria apply: 1. Use of continuous hormonal contraception (i.e., no hormone-free interval) for at least 3 months 2. Age 18-45 years upon entry into screening.
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: 1. History of any primary headache disorder other than migraine without aura (for participants with migraine), or tension-type headache with a frequency of 30 kg/m2. 9. Female participants who are pregnant or breastfeeding or plan to become pregnant or breastfeed during participation in the study. 10. History or evidence of severe psychiatric disorders. 11. Previous participation in a provocation study. 12. Initiation of any new medical treatment and/or device during study period results in exclusion. 13. Participants likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participants’ and investigator’s knowledge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of migraine-like attacks within a 12-hour observation period following administration of atosiban vs. placebo in women with migraine using continuous hormonal contraception. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of headache attacks (all kinds) within a 12-hour observation period following administration of atosiban vs. placebo in women with migraine under continuous hormonal contraception / men with migraine / healthy female controls under continuous hormonal contraception. Headache intensity within a 12-hour observation period following administration of atosiban vs. placebo in women with migraine under continuous hormonal contraception / men with migraine / healthy female controls under continuous hormonal contraception. Changes in mean arterial blood pressure following administration of atosiban vs. placebo in women with migraine under continuous hormonal contraception / men with migraine / healthy female controls under continuous hormonal contraception, calculated as the area under the curve (AUC) between baseline and 180 minutes after migraine induction. Changes in mean heart rate following administration of atosiban vs. placebo in women with migraine under continuous hormonal contraception / men with migraine / healthy female controls under continuous hormonal contraception, calculated as the AUC between baseline and 180 minutes after migraine induction. Changes in the diameter of the superficial temporal artery following administration of atosiban vs. placebo in women with migraine under continuous hormonal contraception / men with migraine / healthy female controls under continuous hormonal contraception, calculated as the AUC between baseline and 180 minutes after migraine induction. Changes in blood flow velocity of the middle cerebral artery following administration of atosiban vs. placebo in women with migraine under continuous hormonal contraception / men with migraine / healthy female controls under continuous hormonal contraception, calculated as the AUC between baseline and 180 minutes after migraine induction. Changes in CGRP levels in saliva following administration of atosiban vs. placebo in women with migraine under continuous horm | — |
Countries
Germany
Contacts
Public ContactBianca Raffaelli
Charité Universitätsmedizin Berlin
Outcome results
None listed