Fremanezumab for the Prevention of Menstrually-related Migraine Attacks

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Fremanezumab
  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.

Первичные конечные точки

• Change of migraine days per month [Срок оценки: 6 months]

Вторичные конечные точки (8)

• Change of disability score MIDAS in points [Срок оценки: 6 months]
• Change of headache-related disability score HIT-6 in points [Срок оценки: 6 months]
• Migraine-specific quality of life in MSQ score in points [Срок оценки: 6 months]
• Anxiety in GAD-7 score, in points [Срок оценки: 6 months]
• Depression in PHQ-8 score, in points [Срок оценки: 6 months]
• Change of fatigue assessed by FSS in points [Срок оценки: 6 months]
• Endometriosis symptoms [Срок оценки: 6 months]
• Hormonal treatment [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 1 центр

• Department of Neurology, Inselspital — Bern

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06659120 · 2024-00388

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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