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 2026-01-21.
Sponsored by University of Florence · Observational
The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of rimegepant as acute 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 gepants, 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 episodic migraine. Previous randomized, placebo-controlled phase 3 trials and open label extensions demonstrated its effectiveness in the acute setting for a single migraine attack of both the oral tablet and the orally disintegrating tablet. Pooled analysis of previous randomized clinical trials also showed rimegepant effectiveness in patients with a history of insufficient response to triptans.
Previous studies also demonstrated a good tolerability profile. The most commonly reported adverse events were nausea, nasopharyngitis, upper respiratory tract infections and urinary tract infection.
In this prospective multicentric study we aim to evaluate Rimegepant effectiveness and tolerability as acute 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. Patients will be asked to treat their next migraine attack with Rimegepant 75 mg orally disintegrating tablet.
Data will be collected at baseline, during at least 4 migraine attacks treated with Rimegepant and at 3 months follow-up.
Subjects will be asked to complete assessment of their migraine attack at baseline and at 30 - 60 - 90 and 120 minutes after administration of the acute treatment for at least four migraine attacks. A final timepoint at 24 hours post-dose will be assessed only for the first attack.
Data collection will focus on: i) demographic data, ii) migraine history, iii) pain level and evolution, iv) presence and evolution of migraine associated symptoms, most bothersome symptom and aura, v) migraine associated disability, vi) patients's global impression of change (PGIC) and evaluation on the acute treatment (Migraine-ACT), vii) tolerability and eventual treatment-emergent adverse events. 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 acute migraine treatments.
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 Disintegrating Oral Tablet
Patients affected by chronic migraine according to ICHD-III criteria.
Drug: Rimegepant 75 MG Disintegrating Oral Tablet
Patients using Rimegepant 75 mg orally disintegrating tablet to treat acute migraine attacks
Headache pain freedom at 2 hours post-dose during the first attack
The percentage of subjects that report no headache pain at 2 hours after drug intake. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).
Time frame: 2 hours post-dose
Occurrence of treatment-emergent adverse events
To evaluate the safety and tolerability of Rimegepant in migraine subjects.
Time frame: 12 weeks
Headache pain freedom at 2 hours post-dose across all treated attacks
The percentage of subjects that report no headache pain at 2 hours after drug intake across all' treated attacks. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).
Time frame: 2 hours post-dose for all treated attacks
Headache pain relief at 2 hours post-dose during the first attack
The percentage of subjects that report mild or none headache pain at 2 hours after drug intake during the first attack. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).
Time frame: 2 hours post-dose
Headache pain relief at 2 hours post-dose across all treated attacks
The percentage of subjects that report mild or none headache pain at 2 hours after drug intake across all treated attack. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).
Time frame: 2 hours post-dose for all treated attacks
Ability to function normally at 2 hours post-dose during the first attack
The percentage of subjects that self-report no functional disability at 2 hours post-dose. Functional disability will be assessed through the Functional Disability Scale (FDS), a four-point scale: normal, mildly impaired, severely impaired, requires daily activities interruption.
Time frame: 2 hours post-dose
Ability to function normally at 2 hours post-dose across all treated attacks
The percentage of subjects that self-report no functional disability at 2 hours post-dose. Functional disability will be assessed through the Functional Disability Scale, a four-point scale: normal, mildly impaired, severely impaired, requires daily activities interruption.
Time frame: 2 hours post-dose for all treated attacks
Freedom from the most bothersome symptom (MBS) associated with migraine at 2 hours post-dose during the first attack
The percentage of subjects that report complete MBS resolution at 2 hours after drug intake. MBS will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).
Time frame: 2 hours post-dose
Headache recurrence for the first-attack
Percentage of subjects who became pain free at 2 hours post-dose and report new headache pain within 24 hours post-dose.
Time frame: between 2 hours and 24 hours post-dose
Rescue medications use for the first attack
Percentage of subjects who take a rescue medication after 2 hour post-dose. Rescue medications will be measured using a binary scale (0=no consumption, 1=consumption)
Time frame: between 2 hours and 24 hours post dose
Treatment satisfaction
Level of patients' self-reported satisfaction which will be measured on a 0-10 visual analogue scale (0=no satisfaction, 10= the highest satisfaction) and Patients Global Impression of Change (0= no changing, 7= a change that makes the difference).
Time frame: 2 hours post-dose for all treated attacks
Self-reported treatment effectiveness
Level of patients' self-reported treatment effectiveness measured by Migraine Assessment of Current Therapy (Migraine-ACT) a 4-item questionnaire about treatment effectiveness and daily life repercussions.
Time frame: 12 weeks
Plan to share: Undecided
Ran from Jun 2023 to primary completion in Jun 2024, 12 months.
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 12 months is below 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.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Florence