NCT06409832

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
16mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Mar 2024Sep 2027

Study Start

First participant enrolled

March 26, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 10, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

2.8 years

First QC Date

April 5, 2024

Last Update Submit

January 19, 2026

Conditions

MigraineMigraine With AuraMigraine Without AuraChronic Migraine

Keywords

HeadacheMedication overuse headachePainMigraine preventionGepantRimegepant

Outcome Measures

Primary Outcomes (2)

  • 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)

    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

    Baseline (T0) - 3 months of treatment with rimegepant (T3)

Secondary Outcomes (14)

  • Changes in migraine frequency across twelve months of rimegepant treatment

    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

    Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with rimegepant

  • Evaluation of any adverse event (qualitative)

    3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant

  • Evaluation of any adverse event (quantitative)

    3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant

  • Evaluation of serious adverse event

    3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant

  • +9 more secondary outcomes

Other Outcomes (12)

  • Changes in the number of monthly migraine days with aura (quantitative)

    Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant

  • Variation of duration of aura (qualitative)

    Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant

  • Variation of type of aura (qualitative)

    Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant

  • +9 more other outcomes

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

Chronic migraine

Patients affected by chronic migraine (\> 15 monthly headache days with at least 8 days with migraine features) according to ICHD-III criteria.

Drug: Rimegepant 75 mg

Interventions

Rimegepant 75 mgDRUG

Patients using Rimegepant 75 mg orally disintegrating tablet every other day as migraine prevention

Also known as: Rimegepant
Chronic migraineEpisodic migraine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Multicentric study on patients attending the outpatient clinic of Italian Headache centres who meet criteria for rimegepant use for migraine preventive treatment.

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 4 monthly migraine days;
  • 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.
  • Changes in preventive treatments in the month before the first administration of rimegepant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 (2)

  • 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: 31291516BACKGROUND

  • Croop 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.

    PMID: 33338437BACKGROUND

MeSH Terms

Conditions

Migraine DisordersMigraine with AuraMigraine without AuraHeadacheHeadache Disorders, SecondaryPain

Interventions

rimegepant sulfate

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Luigi F Iannone, MD

CONTACT

+393896969606luigifrancesco.iannone@unimore.it

Roberto De Icco, MD

CONTACT

roberto.deicco@mondino.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher at the Headache Center and Clinical Pharmacology Unit and the Department of Health Sciences, University of Florence, Principal Investigator

Study Record Dates

First Submitted

April 5, 2024

First Posted

May 10, 2024

Study Start

March 26, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations

IT(2)