NCT06659120Recruiting
Fremanezumab for the Prevention of Menstrually-related Migraine Attacks
Fremanezumab for the Prevention of Menstrually-related Migraine Attacks - a Prospective, Observational Study According to Routine Neurological Care in Switzerland
Source: ClinicalTrials.gov · Last updated 26 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 12 Aug 2024
- Start date
- 9 Apr 2024
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Diseases
- Migraine
- NCT number
- NCT06659120
What you commit to
- Study type: Observational
- Planned participants: 120
- From 9 Apr 2024 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Change of hormone therapy during study treatment.
Other
- Patients with pure menstrual migraine.
- The patient is participating in an interventional clinical trial in EM or CM.
- Progestin-only contraception.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurology, Inselspital Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.