G43.0
Conditions
Interventions
Group 1: The study cohort consists of patients with episodic migraine without aura and a regular menstrual cycle, defined as a cycle duration of 28 ± 5 days in the three months prior to the study.
It
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: History of migraine without aura for =12 months according to the International Classification of Headache Disorders (ICHD-3, Headache Classification Committee, 2018); 1-5 monthly migraine days in the three months prior to screening as self-reported by the participant.
Exclusion criteria
Exclusion criteria: Participants will be excluded from the study if any of the following criteria apply: 1. History of any primary headache disorder other than migraine without aura or tension-type headache with a frequency of <5 headache days per month before screening. 2. History of any secondary headache disorder before screening. 3. Diagnosis of pure-menstrual migraine according to the ICHD-3 appendix criteria. 4. Intake of prophylactic migraine medication within =30 days or 5 plasma half-lives (whichever is longer) prior to screening. 5. Intake of acute migraine medication targeting the CGRP pathway. 6. Intake of hormonal contraception or other hormonal treatment within 90 days prior to screening. 7. History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator will pose a risk to participant safety or interfere with the study evaluation, procedures or completion. 8. Participants who are pregnant, breastfeeding, plan to become pregnant or breastfeed during participation in the study. 9. 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 |
|---|---|
| Primary endpoint of the study is the incidence of migraine attacks in a 12-hour observational period after administration of CGRP during the perimenstrual vs. periovulatory phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint is the incidence of migraine attacks in a 12-hour observational period after administration of CGRP vs. placebo in both menstrual cycle phases. | — |
Countries
Germany
Contacts
Public ContactCarolin Hoehne
Charité Universitätsmedizin Berlin
Outcome results
None listed