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Menstrual MigraineFROMMNCT06659120

Fremanezumab for the Prevention of Menstrually-related Migraine Attacks

An observational study of Menstrual Migraine, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this observational study is to compare, in real-world clinical practice, the effect of fremanezumab on menstrual migraine to the effect of fremanezumab on non-perimenstrual attacks. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Menstrual Migraine
What is being tested?
Fremanezumab
How many people
120 participants
Where
1 siteSwitzerland
Study dates
9 Apr 2024to 31 Mar 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Premenopausal women ≥18 years of age, diagnosed with episodic or chronic migraine, with menstrually-related migraine with or without aura according to IHS Classification (ICHD-3 code A1.1.2 or A1.2.0.2)*, and have been prescribed fremanezumab according to the SmPC as a treatment decision of their physician and enrollment in this study at baseline.

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Christoph J Schankin, Prof contact

00416322111

christoph.schankin@insel.ch

Switzerland1 site, 1 recruiting

  • Department of Neurology, Inselspital

    Bern, 3010

    Christoph J Schankin, Prof, 00416322111, christoph.schankin@insel.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: Fremanezumab for the Prevention of Menstrually-related Migraine Attacks - a Prospective, Observational Study According to Routine Neurological Care in Switzerland

The goal of this observational study is to compare, in real-world clinical practice, the effect of fremanezumab on menstrual migraine to the effect of fremanezumab on non-perimenstrual attacks. The main question it aims to answer is, if menstrually-related migraine attacks respond equally well to anti-CGRP mAb treatment with fremanezumab as non-menstrually-related attacks.

Participants diagnosed with episodic or chronic migraine with menstrually-related migraine with or without aura and treated with fremanzumab according to the SmPC will be required to maintain a headache diary over at least 3 months prior to and 6 months after fremanezumab initiation.

Being tested
Fremanezumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FremanezumabDrug

    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.

Study groups in NCT06659120
Study groupRoleWhat they receive
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).
Receives: Drug: Fremanezumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 6 months

Secondary outcomes (8)

  1. 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.

    Measured: 6 months

  2. Change of headache-related disability score HIT-6 in points

    Headache-related disability score, as measured by the HIT-6, at month 6.

    Measured: 6 months

  3. Migraine-specific quality of life in MSQ score in points

    Migraine-specific quality of life, as measured by the MSQ version 2.1, at month 6.

    Measured: 6 months

  4. Anxiety in GAD-7 score, in points

    Change from baseline in anxiety (GAD-7).

    Measured: 6 months

  5. Depression in PHQ-8 score, in points

    Change from baseline in depression (PHQ-8).

    Measured: 6 months

  6. Change of fatigue assessed by FSS in points

    Change from baseline in sleep questionnaires at month 6 (Fatigue Severity Scale (FSS), Epworth Sleepiness Scale (ESS) and Insomnia Severity Index (ISI)).

    Measured: 6 months

  7. Endometriosis symptoms

    Change from baseline in number of days per month and intensity with typical symptoms of endometriosis (dysmenorrhoea, dyschezia, dysuria and dyspareunia) in women who have menstrually-related migraine and endometriosis (subgroup) at follow-up (months 4 to 6 after initiation of anti-CGRP mAb) compared to baseline (months -3 to -1 prior to initiation). (Headache diary).

    Measured: 6 months

  8. Hormonal treatment

    Change from baseline in number of migraine days in patients with and without concomitant hormonal treatment.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2024
  2. Study start9 Apr 2024
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06659120
Sponsor's protocol ID
2024-00388
Acronym
FROMM
Status last verified
Oct 2024
First submitted
12 Aug 2024
Last updated
26 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 7672904

  • 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.

    PubMed 2367875

  • MacGregor EA, Hackshaw A. Prevalence of migraine on each day of the natural menstrual cycle. Neurology. 2004 Jul 27;63(2):351-3. doi: 10.1212/01.wnl.0000133134.68143.2e.

    PubMed 15277635

  • Chalmer MA, Kogelman LJA, Ullum H, Sorensen E, Didriksen M, Mikkelsen S, Dinh KM, Brodersen T, Nielsen KR, Bruun MT, Banasik K, Brunak S, Erikstrup C, Pedersen OB, Ostrowski SR, Olesen J, Hansen TF. Population-Based Characterization of Menstrual Migraine and Proposed Diagnostic Criteria. JAMA Netw Open. 2023 May 1;6(5):e2313235. doi: 10.1001/jamanetworkopen.2023.13235.

    PubMed 37184838

  • Calhoun A, Ford S. Elimination of menstrual-related migraine beneficially impacts chronification and medication overuse. Headache. 2008 Sep;48(8):1186-93. doi: 10.1111/j.1526-4610.2008.01176.x.

    PubMed 18819179

  • Sevivas H, Fresco P. Treatment of resistant chronic migraine with anti-CGRP monoclonal antibodies: a systematic review. Eur J Med Res. 2022 Jun 4;27(1):86. doi: 10.1186/s40001-022-00716-w.

    PubMed 35659086

  • Ornello R, Frattale I, Caponnetto V, De Matteis E, Pistoia F, Sacco S. Menstrual Headache in Women with Chronic Migraine Treated with Erenumab: An Observational Case Series. Brain Sci. 2021 Mar 13;11(3):370. doi: 10.3390/brainsci11030370.

    PubMed 33805838

  • Verhagen IE, de Vries Lentsch S, van der Arend BWH, le Cessie S, MaassenVanDenBrink A, Terwindt GM. Both perimenstrual and nonperimenstrual migraine days respond to anti-calcitonin gene-related peptide (receptor) antibodies. Eur J Neurol. 2023 Jul;30(7):2117-2121. doi: 10.1111/ene.15794. Epub 2023 Apr 6.

    PubMed 36941533

  • van Casteren DS, Verhagen IE, van der Arend BWH, van Zwet EW, MaassenVanDenBrink A, Terwindt GM. Comparing Perimenstrual and Nonperimenstrual Migraine Attacks Using an e-Diary. Neurology. 2021 Oct 26;97(17):e1661-e1671. doi: 10.1212/WNL.0000000000012723. Epub 2021 Sep 7.

    PubMed 34493613

  • Pavlovic JM, Paemeleire K, Gobel H, Bonner J, Rapoport A, Kagan R, Zhang F, Picard H, Mikol DD. Efficacy and safety of erenumab in women with a history of menstrual migraine. J Headache Pain. 2020 Aug 3;21(1):95. doi: 10.1186/s10194-020-01167-6.

    PubMed 32746775

  • Silvestro M, Orologio I, Bonavita S, Scotto di Clemente F, Fasano C, Tessitore A, Tedeschi G, Russo A. Effectiveness and Safety of CGRP-mAbs in Menstrual-Related Migraine: A Real-World Experience. Pain Ther. 2021 Dec;10(2):1203-1214. doi: 10.1007/s40122-021-00273-w. Epub 2021 Jun 9.

    PubMed 34106431

Questions about this trial

What is this clinical trial studying?

An observational study of Menstrual Migraine, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christoph J Schankin, Prof (00416322111, christoph.schankin@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of migraine days per month (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06659120, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.

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