What the trial was testing
The trial enrolled 1,590 patients with migraine. The study was sponsored by Pfizer and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was mid-stage testing (phase 2/3). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
People taking rimegepant had 4.3 fewer migraine days per month, compared to 3.5 fewer days with placebo.
Lancet (London, England) · 2021 · NCT03732638
These findings — that taking rimegepant every other day reduced migraine frequency by about one extra day compared to placebo — were published in the Lancet (London, England) and represent the headline result of the study.
Researchers tracked outcomes across 1,590 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with migraine, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Rimegepant (Nurtec ODT) is now FDA-approved for both treating and preventing migraines. If you have frequent migraines, talk to your doctor about whether taking this medication every other day might help reduce how often you get them. Side effects were similar to placebo in this study.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open migraine trials
Fremanezumab for the Prevention of Menstrually-related Migraine Attacks
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.
(Italian Migraine Registry, I-GRAINE-NEW)
Rationale Understanding the mechanisms and evolution of migraine is hampered by its nature as a chronic "evolutionary" condition. Patients often come to migraine centers after years of disabling disease, non-specific diagnoses and ineffective treatments. When patients are admitted to the center is therefore the time when their history in terms of disease evolution and healthcare costs is most effectively collected, but also when it is assumed that the treatment strategy offered to the patient will have a greater impact. For this reason, it was decided to conduct a large-scale retrospective and prospective observational study in order to draw a detailed picture of the situation of patients not followed by a specialized center and of the natural history of the disease once the pathway at the specialized center has started. Design A multicenter, observational, retrospective and prospective cohort study, aimed at obtaining a more detailed picture of the situation of patients not followed by a specialized center and of the natural history of the disease once the pathway at the specialized center has started.6,000 of the incident patients (defined as those who had their first visit during the 6 months preceding enrollment in the registry), will be invited to take part in a follow-up and expanded data collection study. Patients will be consecutively enrolled by specialists at each individual site.. Eligible patients who agree to take part in the study by signing an informed consent form will be assessed clinically and through a direct interview with a structured questionnaire organized in several ad hoc sections. Objectives: The aim of the study is: analyze episodic and chronic migraine in Italy from an epidemiological point of view, especially in terms of prevalence of the two forms of migraine and their endophenotypes in different population subgroups; 2. characterize the demographic distribution and clinical characteristics of patients (including the definition of endophenotypes); 3. measure the influence of the disease on the patient's daily activity, in terms of disability (assessed using the validated MIDAS and HIT-6 scales); 4. study the clinical and care pathway (patient journey) and identify the preferred care pathways based on the characteristics of the patients and the migraine subtype; 5. evaluate the prescribed pharmacological treatments, medical visits and diagnostic procedures performed (ascertaining the degree of adherence to current guidelines); 6. analyze the use of health resources by migraine patients, with particular attention to their impact on the SNS. Visits and Treatments: Baseline Visit: Patients enrolled in the study will undergo a thorough clinical and neurological examination. Follow-up Visits: Clinical data will continue to be collected over time, at each scheduled clinic visit based on the needs of clinical practice. Study Population: Adult patients of both sexes with episodic or chronic migraine who have recently attended a specialized migraine center in the I-GRAINE-NEW registry. Estimated Study Duration: The duration of each patient's participation in the study is 24 months from the date of the initial visit to the participating migraine site