Fremanezumab for the Prevention of Menstrually-related Migraine Attacks (FROMM)
October 23, 2024 updated by: Insel Gruppe AG, University Hospital Bern
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.
Study Overview
Study Type
Observational
Enrollment (Estimated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christoph J Schankin, Prof
- Phone Number: 00416322111
- Email: christoph.schankin@insel.ch
Study Locations
-
-
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Bern, Switzerland, 3010
- Recruiting
- Department of Neurology, Inselspital
-
Contact:
- Christoph J Schankin, Prof
- Phone Number: 00416322111
- Email: christoph.schankin@insel.ch
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Women with menstrually-related migraine attacks
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of migraine days per month
Time Frame: 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of disability score MIDAS in points
Time Frame: 6 months
|
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
Time Frame: 6 months
|
Headache-related disability score, as measured by the HIT-6, at month 6.
|
6 months
|
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Migraine-specific quality of life in MSQ score in points
Time Frame: 6 months
|
Migraine-specific quality of life, as measured by the MSQ version 2.1, at month 6.
|
6 months
|
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Anxiety in GAD-7 score, in points
Time Frame: 6 months
|
Change from baseline in anxiety (GAD-7).
|
6 months
|
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Depression in PHQ-8 score, in points
Time Frame: 6 months
|
Change from baseline in depression (PHQ-8).
|
6 months
|
|
Change of fatigue assessed by FSS in points
Time Frame: 6 months
|
Change from baseline in sleep questionnaires at month 6 (Fatigue Severity Scale (FSS), Epworth Sleepiness Scale (ESS) and Insomnia Severity Index (ISI)).
|
6 months
|
|
Endometriosis symptoms
Time Frame: 6 months
|
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).
|
6 months
|
|
Hormonal treatment
Time Frame: 6 months
|
Change from baseline in number of migraine days in patients with and without concomitant hormonal treatment.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christoph J Schankin, Prof, Inselspital, Department of Neurology, Bern
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 9, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
March 31, 2027
Study Registration Dates
First Submitted
August 12, 2024
First Submitted That Met QC Criteria
October 23, 2024
First Posted (Actual)
October 26, 2024
Study Record Updates
Last Update Posted (Actual)
October 26, 2024
Last Update Submitted That Met QC Criteria
October 23, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-00388
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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