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Completed

NCT Number: NCT06409845

Effectiveness and Tolerability of Eptinezumab

The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of eptinezumab as preventive migraine treatment in a cohort of episodic or chronic migraine patients.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Chronic Migraine Headache Headache Disorders Headache Disorders, Primary Headache Disorders, Secondary Migraine Disorders Migraine With Aura Migraine Without Aura Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SISC

Florence, 50134, Italy

About this study

Eptinezumab belongs to the monoclonal antibodies directed against the calcitoning gene related peptide - CGRP (mAbs). It is actually the only mAb administered intravenously, currently available at the dose of 100 or 300mg with a quarterly iv infusion.

It has an indication for migraine prevention for episodic and chronic migraine. Previous randomized, placebo-controlled clinical trials proved its effectiveness in the preventive setting for patients with episodic and chronic migraine.

Moreover, a previous study also supported evidence of faster headache pain freedom and most bothersome symptom resolution after eptinezumab 100mg infusion during migraine acute attack compared to placebo.

RCTs also demonstrated a good tolerability profile. The most commonly reported adverse events were mainly upper respiratory tract infections, fatigue and hypersensitivity reactions.

In this prospective multicentric study the investigators aim to evaluate eptinezumab 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 be administered eptinezumab 100 or 300 mg according to clinicians' judgment, for a time period related to Italian Medicines Agency reimbursability criteria.

Data will be collected at baseline and every three months, up to 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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);
  • Good compliance to study procedures;
  • Availability of headache diary at least of the preceding months before enrolment;
  • At least 8 monthly migraine days.

Exclusion criteria

  • Subjects with contraindications for use of eptinezumab;
  • 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 eptinezumab

Treatment and study plan

Eptinezumab 100 or 300 mg ev

Drug

Patients administered eptinezumab 100 or 300 mg ev quarterly for migraine prevention

Other names: Eptinezumab

Primary outcomes

  1. Changes in migraine frequency after three months of treatment

    Time frame: Baseline (T0) - 3 months of treatment with eptinezumab (T3)

    Changes in monthly migraine days after three months of treatment with eptinezumab compared to baseline (continuous variable)

  2. Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) after three months of treatment

    Time frame: Baseline (T0) - 3 months of treatment with eptinezumab (T3)

    Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) after three months of treatment with eptinezumab (continuous variable)

Secondary outcomes

  1. Changes in migraine frequency across twelve months of eptinezumab treatment

    Time frame: Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Changes in monthly migraine days after six and twelve months of treatment with eptinezumab compared to baseline (continuous variable)

  2. Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) across twelve months of treatment with eptinezumab

    Time frame: Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) after six and twelve months of treatment with eptinezumab (continuous variable)

  3. Evaluation of any adverse event (qualitative)

    Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Type of any adverse events in patients receiving eptinezumab during the observation period (categorical variable)

  4. Evaluation of any adverse event (quantitative)

    Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Percentage of reported adverse events in patients receiving eptinezumab assessed quarterly during the observation period (continuous variable)

  5. Evaluation of serious adverse events

    Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    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 eptinezumab during the observation period (continuous variable)

  6. Evaluation of adverse events leading to treatment discontinuation

    Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Percentage of adverse events leading to treatment discontinuation in patients receiving eptinezumab during the observation period (continuous variable)

  7. Consistency of treatment response

    Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Percentage of patients with a stable 50% response across twelve months of eptinezumab treatment (continuous variable)

  8. Changes in migraine disability (MIDAS)

    Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Changes in MIgraine Disability ASsesment questionnaire across 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)

  9. Changes in migraine disability (HIT-6)

    Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Changes in Headache Impact Test-6 questionnaire across treatment (continuous variable, 36-78 scale, higher scores indicates greater disability)

  10. Changes in response to acute migraine treatment (m-TOQ)

    Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Changes in migraine Treatment Optimization Questionnaire across eptinezumab treatment (continuous variable, 0-8 scale, higher score indicates higher acute therapy effectiveness)

  11. Changes in allodynia (ASC-12)

    Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Changes in Allodynia Symptoms Checklist-12 questionnaire across treatment (continuous variable, 0-24 scale, higher score indicates more severe allodynia)

  12. Changes in interictal burden across eptinezumab treatment (MIBS-4)

    Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Changes in Migraine Interictal Burden Scale-4 questionnaire across 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)

  13. Percentage of patients with Medication overuse headache reverted during treatment

    Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Percentage of patients with a baseline diagnosis of MOH reverted after 3 - 6 and 12 months of eptinezumab treatment (continuous variable)

Other outcomes

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

    Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Changes in monthly migraine days with aura across twelve months treatment (continuous variable)

  2. Variation of duration of aura (qualitative)

    Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Changes in duration of aura across eptinezumab treatment (categorical variable - minutes, assessed through headache diary)

  3. Variation of type of aura (qualitative)

    Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Changes in type of aura across eptinezumab treatment (assessed through headache diary and anamnestic data collection)

  4. MMDs reduction in patients Non-responders to other anti-CGRP mAbs

    Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Change of monthly migraine days across eptinezumab twelve-months treatment in those patients who did not respond to other anti-CGRP mAbs (continuous variable)

  5. Percentage of 50% Responders in patients Non-responders to other anti-CGRP mAbs

    Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Percentage of 50% Responders across eptinezumab treatment in those patients who did not respond to anti-CGRP mAbs (continuous variable)

  6. Changes in migraine duration across treatment

    Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Changes in migraine duration (continuous variable, hours, assessed through a paper diary)

  7. Changes in migraine severity across treatment

    Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Changes in migraine severity across treatment (continuous variable, 0-10 numerical rating scale, higher scores indicate higher severity)

  8. Changes in duration of the most bothersome symptom(s)

    Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Changes in duration of the most bothersome symptom(s) across treatment (continuous variable: minutes, assessed through a paper diary)

  9. Changes in severity of the most bothersome symptom(s)

    Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Changes in durantion and severity of the most bothersome symptom(s) (continuous variable: 0-10 numerical rating scale, higher scores indicate higher severity)

  10. Changes in self-reported effectiveness of eptinezumab treatment

    Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Changes in Patients Global Impression of Change (PGIC) questionnaire across treatment (continuous variable)

  11. Changes in self-reported effectiveness of acute treatment

    Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Changes in self-reported effectiveness of usual acute treatment (qualitative variable)

  12. Changes in perimenstrual attacks

    Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

    Changes in duration, intensity and associated symptoms of perimenstrual attacks

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Collaborators

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

Registry information

Official study title

Effectiveness and Tolerability of Eptinezumab: a Prospective, Multicentric, Cohort Study

Acronym: TACHIS

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 10, 2024
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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