Effectiveness and Tolerability of Eptinezumab (TACHIS)

June 9, 2026 updated by: Luigi Francesco Iannone, University of Florence

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Simona Guerzoni, MD

Study Locations

  • Italy
    • Florence
      • Florence, Florence, Italy, 50134
        • SISC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Episodic migraine
Patients affected by migraine with an episodic pattern (< 15 monthly migraine days) with or without aura according to ICHD-III criteria.
Drug: Eptinezumab 100 or 300 mg ev
Patients administered eptinezumab 100 or 300 mg ev quarterly for migraine prevention
Other Names:
  • Eptinezumab
Chronic migraine
atients affected by chronic migraine (> 15 monthly headache days with at least 8 days with migraine features) according to ICHD-III criteria.
Drug: Eptinezumab 100 or 300 mg ev
Patients administered eptinezumab 100 or 300 mg ev quarterly for migraine prevention
Other Names:
  • Eptinezumab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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
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)
Baseline (T0) - 3 months of treatment with eptinezumab (T3)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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) 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)
Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
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)
3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
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)
3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
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)
3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
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)
3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
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)
3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
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)
3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
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)
3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
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)
3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
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)
3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
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)
3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
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)
3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
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 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
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)
3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
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)
3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
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)
3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
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)
3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
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)
3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
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)
3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
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)
3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
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)
3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
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)
3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
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
3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florence

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Roma La Sapienza
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Azienda Ospedaliero-Universitaria di Parma
Azienda Ospedaliera S. Maria della Misericordia
IRCCS National Neurological Institute "C. Mondino" Foundation
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Università degli Studi dell'Aquila
Azienda Policlinico Umberto I
Cliniche Humanitas Gavazzeni
Ospedale Santo Stefano
Azienda Ospedaliero Universitaria Policlinico Modena
A.O.U. Città della Salute e della Scienza
Euganea Health Unit, Padua, Italy
Asst Degli Spedali Civili Di Brescia
University of Campania Luigi Vanvitelli
Società Italiana per lo Studio delle Cefalee
Auxologico San Luca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RICe_5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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