Effects of oxytocin receptor antagonization in migraine: A randomized, double-blind, placebo-controlled human provocation study

Not Applicable

Recruiting

• Conditions: G43.0; Migraine without aura [common migraine]

• Registration Number: DRKS00033341
• Lead Sponsor: Charité Universtitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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

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 <5 headache days per month before screening according to the IHS criteria, based on medical records and/or patient self-report.
2. History of any secondary headache disorder before screening, based on medical records and/or patient self-report.
3. Intake of prophylactic migraine medication within =30 days or 5 plasma half-lives (whichever is longer) prior to screening.
4. Intake of hormonal treatments other than hormonal contraception.
3. History or evidence of neurological disorders (e.g., multiple sclerosis, brain tumor, history of severe traumatic brain injury, history of brain surgery).
4. History or evidence of severe inflammatory diseases (infectious, rheumatic).
5. Evidence of arterial hypertension.
6. History or evidence of cardiovascular diseases (e.g., cerebral ischemia, coronary heart disease, history of myocardial infarction, peripheral arterial disease, severe heart valve disease).
7. Evidence of Diabetes mellitus.
8. Body Mass Index <18 or >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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.