Gepant treAtments: EffectIveNess and tolERability (GAINER)

NCT05903027 | Recruiting DMC

• 1 other identifier: RICe_1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Migraine Without Aura; Chronic Migraine; Migraine; Migraine With Aura

Keywords

Headache; Medication overuse headache; Pain; Gepant; Triptan

Outcome Measures

Primary Outcomes (2)

• 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).

  2 hours post-dose

• Occurrence of treatment-emergent adverse events

  To evaluate the safety and tolerability of Rimegepant in migraine subjects.

  12 weeks

Secondary Outcomes (10)

• Headache pain freedom at 2 hours post-dose across all treated attacks

  2 hours post-dose for all treated attacks

• Headache pain relief at 2 hours post-dose during the first attack

  2 hours post-dose

• Headache pain relief at 2 hours post-dose across all treated attacks

  2 hours post-dose for all treated attacks

• Ability to function normally at 2 hours post-dose during the first attack

  2 hours post-dose

• Ability to function normally at 2 hours post-dose across all treated attacks

  2 hours post-dose for all treated attacks

Study Arms (2)

Episodic migraine

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

Chronic migraine

Patients affected by chronic migraine according to ICHD-III criteria.

Drug: Rimegepant 75 MG Disintegrating Oral Tablet

Interventions

Rimegepant 75 MG Disintegrating Oral Tablet DRUG

Patients using Rimegepant 75 mg orally disintegrating tablet to treat acute migraine attacks

Chronic migraine; Episodic migraine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multicentric study on patients attending the outpatient clinic of Italian Headache centres who meet criteria for Rimegepant use for acute migraine treatments.

You may qualify if:

• Diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III).
• At least 3 MMDs
• Good compliance to study procedures
• Availability of headache diary at least of the preceding months before enrollment

You may not qualify if:

• Subjects with contraindications for use of gepants;
• 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.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: collaborator
• Università degli Studi dell'Aquila: collaborator
• University of Roma La Sapienza: collaborator
• Azienda Ospedaliero Universitaria Policlinico Modena: collaborator
• Ospedale di Piove di Sacco: collaborator
• Azienda Ospedaliero-Universitaria di Parma: collaborator
• Azienda Ospedaliera S. Maria della Misericordia: collaborator
• A.O.U. Città della Salute e della Scienza: collaborator
• Cliniche Humanitas Gavazzeni: collaborator
• University of Campania Luigi Vanvitelli: collaborator
• Ospedale Santo Stefano: collaborator
• Azienda Policlinico Umberto I: collaborator
• Auxologico San Luca: collaborator
• Asst Degli Spedali Civili Di Brescia: collaborator
• Carlo Besta Neurological Institute: collaborator
• IRCCS National Neurological Institute "C. Mondino" Foundation: collaborator
• University of Florence: lead
• Società Italiana per lo Studio delle Cefalee: collaborator

Study Sites (2)

SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi

Florence, 50134, Italy

RECRUITING

IRCCS National Neurological Institute "C. Mondino" Foundation

Pavia, 27100, Italy

RECRUITING

Related Publications (4)

• 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.

  PMID: 31291516 BACKGROUND

• Croop R, Goadsby PJ, Stock DA, Conway CM, Forshaw M, Stock EG, Coric V, Lipton RB. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. 2019 Aug 31;394(10200):737-745. doi: 10.1016/S0140-6736(19)31606-X. Epub 2019 Jul 13.

  PMID: 31311674 BACKGROUND

• Lipton RB, Blumenfeld A, Jensen CM, Croop R, Thiry A, L'Italien G, Morris BA, Coric V, Goadsby PJ. Efficacy of rimegepant for the acute treatment of migraine based on triptan treatment experience: Pooled results from three phase 3 randomized clinical trials. Cephalalgia. 2023 Feb;43(2):3331024221141686. doi: 10.1177/03331024221141686.

  PMID: 36739511 BACKGROUND

• Iannone LF, Vaghi G, Sebastianelli G, Casillo F, Russo A, Silvestro M, Pistoia F, Volta GD, Cortinovis M, Chiarugi A, Montisano DA, Prudenzano MP, Cevoli S, Mampreso E, Avino G, Romozzi M, Valente M, Fasano C, Battistini S, Granato A, Piella EM, Rainero I, Ornello R, De Icco R; Italian Headache Registry (RICe) Study Group. Effectiveness and tolerability of rimegepant in the acute treatment of migraine: a real-world, prospective, multicentric study (GAINER study). J Headache Pain. 2025 Jan 6;26(1):4. doi: 10.1186/s10194-024-01935-8.

  PMID: 39762740 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Migraine with Aura; Migraine without Aura; Headache; Headache Disorders, Secondary; Pain

Interventions

rimegepant sulfate

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Luigi F Iannone, MD

CONTACT

+393896969606; luigifrancesco.iannone@unifi.it

Roberto De Icco, MD

CONTACT

roberto.deicco@mondino.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 15, 2023
• Study Start: June 15, 2023
• Primary Completion: June 15, 2024
• Study Completion (Estimated): September 15, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

IT (2)