Fremanezumab for the Prevention of Menstrually-related Mi... | NCT06659120

NCT06659120

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Women with menstrually-related migraine attacks		Premenopausal women of 18 years of age or older. Women with a regular cycle 21-32 days. The patient has a diagnosis of chronic or episodic migraine. Women suffering from migraine with or without aura according to International Headache Society (IHS) Classification (ICHD-3 code A1.1.2 or A1.2.0.2) for at least one year. Women suffering of at least 2 days of menstrually-related migraine per period on average in the last three periods (baseline measurements and inclusion criteria).	Drug: Fremanezumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fremanezumab	Drug	Initiation of anti-CGRP mAb (fremanezumab) treatment according to the Summary of Product Characteristics (SmPC) during clinical routine as a treatment of their physician (no study-specific intervention). This means that patients have to fulfil criteria for treatment with anti-CGRP mAbs in Switzerland, i.e. they have at least 8 days of migraine per month in the last three months.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of migraine days per month	Difference in relative reduction of migraine days per month between menstrually-related and non-menstrual migraine days at follow-up (months 4 to 6 after initiation of anti-CGRP mAb) compared to baseline (months -3 to -1 prior to initiation).	6 months

Secondary Outcomes

Measure	Description	Time Frame
Change of disability score MIDAS in points	Change from baseline in disability score, as measured by the Migraine Disability Assessment (MIDAS) questionnaire, at month 6.	6 months
Change of headache-related disability score HIT-6 in points

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Premenopausal women of 18 years of age or older.
Women with a regular cycle 21-32 days.
The patient has a diagnosis of chronic or episodic migraine.
Women suffering from migraine with or without aura according to International Headache Society (IHS) Classification (ICHD-3 code A1.1.2 or A1.2.0.2) for at least one year.
Women suffering of at least 2 days of menstrually-related migraine per period on average in the last three periods (baseline measurements and inclusion criteria).
The patient has been maintaining a daily headache diary as part of her routine disease management per her treating physician and has 3 months headache diary data prior to baseline/ treatment initiation. Notes: The patient's headache diary captures information on each headache day, headache duration, headache severity, medication intake, each day of menstrual bleeding, pain intensity of symptoms associated with the menstrual bleeding and symptoms of endometriosis (if present): dysmenorrhoea, dyschezia, dyspareunia, dysuria.
The patient understands and is willing to keep records in their headache diary for the course of the study.
Initiation of anti-CGRP mAb (fremanezumab) treatment according to the Summary of Product Characteristics (SmPC) during clinical routine as a treatment of their physician (no study-specific intervention). This means that patients have to fulfil criteria for treatment with anti-CGRP mAbs in Switzerland, i.e. they have at least 8 days of migraine per month in the last three months.
The patient has signed the informed consent.

Exclusion Criteria:

Patients with pure menstrual migraine.
The patient is treated with another anti-CGRP mAb.
The patient is not treated with fremanezumab according to the SmPC.
The patient is being treated with another anti-CGRP-based preventive migraine medication within 6 months of enrolment.
The patient is participating in an interventional clinical trial in EM or CM.
Change of hormone therapy during study treatment.
Progestin-only contraception.

Name	Role	Phone	Extension	Email
Christoph J Schankin, Prof	Contact	00416322111		christoph.schankin@insel.ch

Name	Affiliation	Role
Christoph J Schankin, Prof	Inselspital, Department of Neurology, Bern	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology, Inselspital	Recruiting	Bern		3010	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
7672904	Background	Russell MB, Rasmussen BK, Thorvaldsen P, Olesen J. Prevalence and sex-ratio of the subtypes of migraine. Int J Epidemiol. 1995 Jun;24(3):612-8. doi: 10.1093/ije/24.3.612.
2367875	Background	Celentano DD, Linet MS, Stewart WF. Gender differences in the experience of headache. Soc Sci Med. 1990;30(12):1289-95. doi: 10.1016/0277-9536(90)90309-g.