Fremanezumab for the Prevention of Menstrually-related Migraine Attacks

NCT06659120 | Recruiting

• 1 other identifier: 2024-00388
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Menstrual Migraine

Outcome Measures

Primary Outcomes (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).

  6 months

Secondary Outcomes (8)

• Change of disability score MIDAS in points

  6 months

• Change of headache-related disability score HIT-6 in points

  6 months

• Migraine-specific quality of life in MSQ score in points

  6 months

• Anxiety in GAD-7 score, in points

  6 months

• Depression in PHQ-8 score, in points

  6 months

Study Arms (1)

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

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.

Women with menstrually-related migraine attacks

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Neurology, Inselspital

Bern, 3010, Switzerland

RECRUITING

Related Publications (11)

• 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.

  PMID: 7672904 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.

  PMID: 2367875 BACKGROUND

• 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.

  PMID: 15277635 BACKGROUND

• 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.

  PMID: 37184838 BACKGROUND

• 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.

  PMID: 18819179 BACKGROUND

• 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.

  PMID: 35659086 BACKGROUND

• 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.

  PMID: 33805838 BACKGROUND

• 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.

  PMID: 36941533 BACKGROUND

• 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.

  PMID: 34493613 BACKGROUND

• 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.

  PMID: 32746775 BACKGROUND

• 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.

  PMID: 34106431 BACKGROUND

MeSH Terms

Interventions

fremanezumab

Study Officials

• Christoph J Schankin, Prof

  Inselspital, Department of Neurology, Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph J Schankin, Prof

CONTACT

00416322111; christoph.schankin@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: October 26, 2024
• Study Start: April 9, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

CH (1)