Fremanezumab for Menstrual Migraine

This trial aims to determine if fremanezumab, an injectable medicine, can reduce migraines associated with menstrual periods. Participants will receive either the active medicine or a placebo (inactive substitute) and will record their migraine experiences in diaries. The trial targets women aged 18 to 45 who have migraines linked to their menstrual cycle and have experienced these migraines for at least six months. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits a broader range of patients.

The trial requires that you do not start any new migraine preventive medications during the study. However, it does not specify if you need to stop taking your current medications, so it's best to discuss this with the study team.

Studies have shown that fremanezumab is generally well-tolerated by patients. Research involving over 2,800 people with occasional or frequent migraines found fremanezumab to be safe, as it did not cause major heart or brain problems. Reports confirmed its safety over a 12-week period compared to a placebo, a substance with no active medicine. While no treatment is entirely risk-free, fremanezumab's history suggests it is safe for most people. Prospective trial participants can find reassurance in this information regarding the treatment's safety.¹²³⁴⁵

Fremanezumab is unique because it targets the calcitonin gene-related peptide (CGRP) pathway, which is a key player in the development of migraines. Unlike standard treatments for menstrual migraines, such as NSAIDs and hormonal therapies, fremanezumab directly interrupts the migraine process by blocking CGRP, a protein that spikes during migraines and contributes to pain and inflammation. Researchers are excited about fremanezumab because it offers a targeted approach that could potentially provide relief for those who haven't responded well to existing treatments. Plus, its dosing schedule—just once every three months—could make it a convenient option for patients seeking long-lasting migraine control.

Research has shown that fremanezumab, which participants in this trial may receive, effectively reduces the number of migraine days. This treatment targets a specific pathway in the body. Studies found that over 66% of people with occasional migraines and about 51.6% with frequent migraines experienced a significant reduction—at least 50%—in their monthly migraine days. In simpler terms, more than half of the patients had fewer migraines after using fremanezumab. This is promising for those who suffer from migraines, especially those linked to menstruation. The evidence suggests that this treatment can provide meaningful relief for many people.³⁶⁷⁸⁹