An observational study in Migraine, Migraine With Aura and Migraine Without Aura, sponsored by University of Florence. Recruiting at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by University of Florence · Observational
The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of rimegepant as preventive migraine treatment in a cohort of episodic or chronic migraine patients.
Rimegepant belongs to the gepants family, small molecules calcitonin gene- related peptide (CGRP) receptor antagonists. It is a new generation gepant, currently available as an orally disintegrating tablet at a single dose of 75 mg.
It has a double indication both for acute treatment for migraine with and without aura and preventive treatment of migraine. A previous randomized, placebo-controlled phase 2/3 trial demonstrated its effectiveness and tolerability in the preventive setting for patients with episodic and chronic migraine. Previous studies also demonstrated a good tolerability profile. The most commonly reported adverse events were nausea, nasopharyngitis, upper respiratory tract infections and urinary tract infections.
In this prospective multicentric study the investigators aim to evaluate rimegepant effectiveness and tolerability as preventive migraine treatment in a real-world setting. Subjects who meet the inclusion criteria will be enrolled and will participate in the study. Baseline demographic and clinical data will be collected at the baseline visit. The observation period will last for two years during which patients will take rimegepant 75 mg orally disintegrating tablet every other day for a time period related to eventual approval of reimbursability criteria.
Data will be collected at baseline and every three months for two years. Subjects will be asked to keep a headache diary to collect monthly headache and migraine days, migraine severity, associated symptoms and drug consumption. Questionnaires will be collected every three months.
Data collection will focus on: i) demographic data, ii) migraine history, iii) pain intensity, iv) presence and evolution of migraine associated symptoms and aura, v) migraine associated disability, vi) tolerability and eventual treatment- emergent adverse events, vii) treatment persistence, viii) questionnaires related to disability, allodynia, quality of life, interictal burden and effectiveness of the ongoing acute and preventive treatments. The online database REDCap will be used for data collection.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 100 is below the median of 137 across 331 observational studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →University of Florence is the lead sponsor of 76 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Multicentric study on patients attending the outpatient clinic of Italian Headache centres who meet criteria for rimegepant use for migraine preventive treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients affected by an episodic pattern migraine(\< 15 monthly headache days) with or without aura according to ICHD-III criteria.
Drug: Rimegepant 75 mg
Patients using Rimegepant 75 mg orally disintegrating tablet every other day as migraine prevention
Also known as: Rimegepant
Changes in migraine frequency after three months of treatment
Changes in monthly migraine days after three months of treatment with rimegepant compared to baseline (continuous variable)
Time frame: Baseline (T0) - 3 months of treatment with rimegepant (T3)
Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) after three months of treatment with rimegepant
Percentage of 50% Responders (namely patients who presented a reduction of MMDs \>/ = 50% compared to baseline) after three months of treatment with rimegepant
Time frame: Baseline (T0) - 3 months of treatment with rimegepant (T3)
Changes in migraine frequency across twelve months of rimegepant treatment
Change of monthly migraine days after six and twelve months of treatment with rimegepant compared to baseline (continuous variable)
Time frame: Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) across twelve months of treatment with rimegepant
Percentage of 50% Responders (namely patients who presented a reduction of MMDs \>/ = 50% compared to baseline) after six and twelve months of treatment with rimegepant
Time frame: Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Evaluation of any adverse event (qualitative)
Type of any adverse events in patients receiving rimegepant during the observation period (categorical variable)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Evaluation of any adverse event (quantitative)
Percentage of reported adverse events in patients receiving rimegepant during the observation period (continuous variable)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Evaluation of serious adverse event
Percentage of serious adverse events (namely those resulting in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect) in patients receiving rimegepant during the observation period (continuous variable)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Evaluation of adverse event leading to treatment discontinuation
Percentage of adverse events leading to treatment discontinuation in patients receiving rimegepant during the observation period (continuous variable)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Consistency of treatment response
Percentage of patients with a stable 50% response during rimegepant treatment ( from 3 to 12 months of treatment) (continuous variable)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Changes in migraine disability (MIDAS)
Changes in MIgraine Disability ASsement questionnaire across rimegepant treatment (continuous variable, 0-270 scale, higher scores indicate higher disability: 0-5, little/no disability; 6-10, mild disability; 11-20, moderate disability; \>20, severe disability)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Changes in migraine disability (HIT-6)
Changes in Headache Impact Test-6 questionnaire across rimegepant treatment (continuous variable, 36-78 scale, higher scores indicates greater disability)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Changes in response to acute migraine treatment (m-TOQ)
Changes in migraine Treatment Optimization Questionnaire across rimegepant treatment (continuous variable, 0-8 scale, higher score indicates higher acute therapy effectiveness)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Changes in allodynia across rimegepant treatment (ASC-12)
Changes in Allodynia Symptoms Checklist-12 questionnaire across rimegepant treatment (continuous variable, 0-24 scale, higher score indicates more severe allodynia)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Changes in quality of life across rimegepant treatment (MSQ)
Changes in Migraine Specific Quality of life questionnaire across rimegepant treatment (continuous variable, 0-100 scale, 100 indicates full functionality)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Changes in interictal burden across rimegepant treatment (MIBS-4)
Changes in Migraine Interictal Burden Scale-4 questionnaire across rimegepant treatment (continuous variable, 0-4 scale, 0 indicates no interictal burden, 1-2 mild level of interictal burden, 3 moderate interictal burden, 4 severe interictal burden)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Percentage of patients with Medication overuse reverted during treatment
Percentage of patients with a baseline diagnosis of MO reverted after 3 - 6 and 12 months of rimegepant treatment (continuous variable)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Changes in the number of monthly migraine days with aura (quantitative)
Changes in the number of monthly migraine days with aura across rimegepant treatment (continuous variable, through headache diary assessment)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Variation of duration of aura (qualitative)
Changes in duration of aura across rimegepant treatment (categorical variable - minutes, assessed through headache diary)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Variation of type of aura (qualitative)
Changes in type of aura across rimegepant treatment (assessed through headache diary and anamnestic data collection)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
MMDs reduction in patients Non-responders to mAbs
Change of monthly migraine days across rimegepant treatment in those patients who did not respond to anti-CGRP mAbs (continuous variable)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Percentage of 50% Responders in patients Non-responders to anti CGRP mAbs
Percentage of 50% Responders across rimegepant treatment in those patients who did not respond to anti-CGRP mAbs (continuous variable)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Menstrually-related migraine
Change in the number of menstrually-related attacks (according to ICHD-3) across rimegepant treatment compared to baseline (continuous variable)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Change in self-reported effectiveness of rimegepant treatment
Change in Patients Global Impression of Change (PGIC) questionnaire across treatment (continuous variable, scale 0-7, 1 very much improved, 2 much improved, 3 minimally improved, 4 no change, 5 minimally worse, 6 much worse, 7 very much worse)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Changes in migraine severity
Changes in migraine severity (continuous variable, 0-10 numerical rating scale, higher scores indicate higher severity)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Changes in migraine duration across treatment
Changes in migraine duration across treatment (continuous variable, hours, assessed through a paper diary)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Changes in duration of the most bothersome symptom(s)
Changes in duration of the most bothersome symptom(s) (continuous variable, minutes, assessed through a paper diary)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Changes in severity of the most bothersome symptom(s)
Changes in severity of the most bothersome symptom(s) (continuous variable: 0-10 numerical rating scale, higher scores indicate higher severity)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Changes in self-reported effectiveness of acute treatment
Changes in self-reported effectiveness of usual acute treatment (Patients Global Impression of Change questionnaire across treatment: continuous variable, scale 0-7, 1 very much improved, 2 much improved, 3 minimally improved, 4 no change, 5 minimally worse, 6 much worse, 7 very much worse)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Started Mar 2024 (actual). Primary completion is estimated for Jan 2027, 33 months after the start.
Of 132 non-industry observational studies under Migraine Disorders, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 72. This study's planned 33 months is above that.
Counting every sponsor, half of 160 studies reached it within 27 months; a quarter within 13 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
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University of Florence