MigraineRAISENCT06409832
RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment
An observational study of Migraine and Migraine With Aura, run by University of Florence at 2 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Migraine With Aura, Migraine Without Aura
- What is being tested?
- Rimegepant 75 mg
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 2 sitesItaly
- Study dates
- 26 Mar 2024to Sep 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Multicentric study on patients attending the outpatient clinic of Italian Headache centres who meet criteria for rimegepant use for migraine preventive treatment.
Who may be able to join
- Diagnosis of migraine without aura or migraine with aura, according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III);
- At least 4 monthly migraine days;
- Good compliance to study procedures;
- Availability of headache diary at least of the preceding months before enrollment.
Who cannot join
- Subjects with contraindications for use of gepants;
- Diagnosis of chronic migraine
- Concomitant diagnosis of medical diseases and/or comorbidities that, in the Investigator's opinion might interfere with study assessments;
- medical comorbidities that could interfere with study results;
- Pregnancy and breastfeeding.
- Changes in preventive treatments in the month before the first administration of rimegepant
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Roberto De Icco, MD contact
Italy2 sites, 2 recruiting
- Recruiting
SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi
Florence, Florence, 50134
Luigi F Iannone, MD, luigifrancesco.iannone@unifi.it
- Recruiting
IRCCS National Neurological Institute "C. Mondino" Foundation
Pavia, Pavia, 27100
Roberto De Icco, MD, roberto.deicco@mondino.it
About this study
Official title: RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment: a Prospective, Multicentric, Cohort Study (RAISE)
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.
Read the detailed description
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.
- Conditions
- Migraine, Migraine With Aura, Migraine Without Aura
- Being tested
- Rimegepant 75 mg
- Keywords
- Headache, Medication overuse headache, Pain, Migraine prevention, Gepant, Rimegepant
- Medical subject headings
- Migraine Disorders, Migraine with Aura, Migraine without Aura, Headache, Headache Disorders, Secondary, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rimegepant 75 mgDrug
Also called Rimegepant
Patients using Rimegepant 75 mg orally disintegrating tablet every other day as migraine prevention
| Study group | Role | What they receive |
|---|---|---|
| Episodic migraine | Patients affected by an episodic pattern migraine(< 15 monthly headache days) with or without aura according to ICHD-III criteria. Receives: Drug: Rimegepant 75 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Baseline (T0) - 3 months of treatment with rimegepant (T3)
Secondary outcomes (14)
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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start26 Mar 2024
- Primary completion1 Jan 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS National Neurological Institute "C. Mondino" Foundation, Società Italiana per lo Studio delle Cefalee, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, Università degli Studi dell'Aquila, University of Roma La Sapienza, Azienda Ospedaliero Universitaria Policlinico Modena, ULSS6 - Ospedale di Piove di Sacco, Azienda Ospedaliero-Universitaria di Parma, Azienda Ospedaliera S. Maria della Misericordia, A.O.U. Città della Salute e della Scienza, Cliniche Humanitas Gavazzeni, University of Campania Luigi Vanvitelli, Ospedale Santo Stefano, Azienda Policlinico Umberto I, Auxologico San Luca, Asst Degli Spedali Civili Di Brescia, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Responsible party
- Principal investigator, Luigi Francesco Iannone, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409832
- Sponsor's protocol ID
- RICe_3
- Acronym
- RAISE
- Status last verified
- Jun 2026
- First submitted
- 5 Apr 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lipton RB, Croop R, Stock EG, Stock DA, Morris BA, Frost M, Dubowchik GM, Conway CM, Coric V, Goadsby PJ. Rimegepant, an Oral Calcitonin Gene-Related Peptide Receptor Antagonist, for Migraine. N Engl J Med. 2019 Jul 11;381(2):142-149. doi: 10.1056/NEJMoa1811090.
PubMed 31291516Croop R, Lipton RB, Kudrow D, Stock DA, Kamen L, Conway CM, Stock EG, Coric V, Goadsby PJ. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. 2021 Jan 2;397(10268):51-60. doi: 10.1016/S0140-6736(20)32544-7. Epub 2020 Dec 15.
PubMed 33338437
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment: a Prospective, Multicentric, Cohort Study (RAISE)
- ClinicalTrials.gov ID
- NCT06409832
- Acronym / sponsor ID
- RAISE / RICe_3
- Conditions
- Migraine, Migraine With Aura, Migraine Without Aura
- Keywords
- Headache, Medication overuse headache, Pain, Migraine prevention, Gepant, Rimegepant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Collaborators
- IRCCS National Neurological Institute "C. Mondino" Foundation, Società Italiana per lo Studio delle Cefalee, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, Università degli Studi dell'Aquila, University of Roma La Sapienza, Azienda Ospedaliero Universitaria Policlinico Modena, ULSS6 - Ospedale di Piove di Sacco, Azienda Ospedaliero-Universitaria di Parma, Azienda Ospedaliera S. Maria della Misericordia, A.O.U. Città della Salute e della Scienza, Cliniche Humanitas Gavazzeni, University of Campania Luigi Vanvitelli, Ospedale Santo Stefano, Azienda Policlinico Umberto I, Auxologico San Luca, Asst Degli Spedali Civili Di Brescia, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Episodic migraine | – | Drug: Rimegepant 75 mgPatients affected by an episodic pattern migraine(< 15 monthly headache days) with or without aura according to ICHD-III criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multicentric study on patients attending the outpatient clinic of Italian Headache centres who meet criteria for rimegepant use for migraine preventive treatment.
Key inclusion criteria (4 listed)
- Diagnosis of migraine without aura or migraine with aura, according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III);
- At least 4 monthly migraine days;
- Good compliance to study procedures;
- Availability of headache diary at least of the preceding months before enrollment.
Key exclusion criteria (6 listed)
- Subjects with contraindications for use of gepants;
- Diagnosis of chronic migraine
- Concomitant diagnosis of medical diseases and/or comorbidities that, in the Investigator's opinion might interfere with study assessments;
- medical comorbidities that could interfere with study results;
- Pregnancy and breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rimegepant 75 mgAlso: RimegepantPatients using Rimegepant 75 mg orally disintegrating tablet every other day as migraine prevention | Drug | Episodic migraine |
Primary outcome
Changes in migraine frequency after three months of treatment
Time frame: Baseline (T0) - 3 months of treatment with rimegepant (T3)
Changes in monthly migraine days after three months of treatment with rimegepant compared to baseline (continuous variable)
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)
Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) after three months of treatment with rimegepant
14 secondary outcomes
Changes in migraine frequency across twelve months of rimegepant treatment
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
Time frame: Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Evaluation of any adverse event (qualitative)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Evaluation of any adverse event (quantitative)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Evaluation of serious adverse event
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Evaluation of adverse event leading to treatment discontinuation
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Consistency of treatment response
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Changes in migraine disability (MIDAS)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Changes in migraine disability (HIT-6)
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)
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)
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)
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)
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
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 31291516Lipton RB, Croop R, Stock EG, Stock DA, Morris BA, Frost M, Dubowchik GM, Conway CM, Coric V, Goadsby PJ. Rimegepant, an Oral Calcitonin Gene-Related Peptide Receptor Antagonist, for Migraine. N Engl J Med. 2019 Jul 11;381(2):142-149. doi: 10.1056/NEJMoa1811090.
- Background: PubMed 33338437Croop R, Lipton RB, Kudrow D, Stock DA, Kamen L, Conway CM, Stock EG, Coric V, Goadsby PJ. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. 2021 Jan 2;397(10268):51-60. doi: 10.1016/S0140-6736(20)32544-7. Epub 2020 Dec 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roberto De Icco, MD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Migraine With Aura, run by University of Florence at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luigi F Iannone, MD (+393896969606, luigifrancesco.iannone@unimore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in migraine frequency after three months of treatment (time frame: Baseline (T0) - 3 months of treatment with rimegepant (T3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06409832, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.