MigraineTACHISNCT06409845
Effectiveness and Tolerability of Eptinezumab
An observational study of Migraine and Migraine With Aura, run by University of Florence at 1 site in Italy.
Trial summary
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. 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?
- Eptinezumab 100 or 300 mg ev
- How many people
- 130 participants
- Where
- 1 siteItaly
- Study dates
- 26 Mar 2024to 1 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 eptinezumab use as migraine preventive treatment
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Migraine, Migraine With Aura, Migraine Without Aura, Chronic Migraine
- Being tested
- Eptinezumab 100 or 300 mg ev
- Keywords
- Headache, Medication overuse headache, Pain, Migraine prevention, Anti-CGRP monoclonal antibodies, eptinezumab
- 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.
Eptinezumab 100 or 300 mg evDrug
Also called Eptinezumab
Patients administered eptinezumab 100 or 300 mg ev quarterly for migraine prevention
| Study group | Role | What they receive |
|---|---|---|
| Episodic migraine | Patients affected by migraine with an episodic pattern (< 15 monthly migraine days) with or without aura according to ICHD-III criteria. Receives: Drug: Eptinezumab 100 or 300 mg ev | |
| Chronic migraine | atients affected by chronic migraine (> 15 monthly headache days with at least 8 days with migraine features) according to ICHD-III criteria. Receives: Drug: Eptinezumab 100 or 300 mg ev |
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 eptinezumab compared to baseline (continuous variable)
Measured: 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
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)
Measured: Baseline (T0) - 3 months of treatment with eptinezumab (T3)
Secondary outcomes (13)
Changes in migraine frequency across twelve months of eptinezumab treatment
Changes in monthly migraine days after six and twelve months of treatment with eptinezumab compared to baseline (continuous variable)
Measured: 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
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)
Measured: Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
Evaluation of any adverse event (qualitative)
Type of any adverse events in patients receiving eptinezumab during the observation period (categorical variable)
Measured: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
Evaluation of any adverse event (quantitative)
Percentage of reported adverse events in patients receiving eptinezumab assessed quarterly during the observation period (continuous variable)
Measured: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
Evaluation of serious adverse events
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)
Measured: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
Evaluation of adverse events leading to treatment discontinuation
Percentage of adverse events leading to treatment discontinuation in patients receiving eptinezumab during the observation period (continuous variable)
Measured: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
Consistency of treatment response
Percentage of patients with a stable 50% response across twelve months of eptinezumab treatment (continuous variable)
Measured: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
Changes in migraine disability (MIDAS)
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)
Measured: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
Changes in migraine disability (HIT-6)
Changes in Headache Impact Test-6 questionnaire across treatment (continuous variable, 36-78 scale, higher scores indicates greater disability)
Measured: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
Changes in response to acute migraine treatment (m-TOQ)
Changes in migraine Treatment Optimization Questionnaire across eptinezumab treatment (continuous variable, 0-8 scale, higher score indicates higher acute therapy effectiveness)
Measured: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
Changes in allodynia (ASC-12)
Changes in Allodynia Symptoms Checklist-12 questionnaire across treatment (continuous variable, 0-24 scale, higher score indicates more severe allodynia)
Measured: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
Changes in interictal burden across eptinezumab treatment (MIBS-4)
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)
Measured: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
Percentage of patients with Medication overuse headache reverted during treatment
Percentage of patients with a baseline diagnosis of MOH reverted after 3 - 6 and 12 months of eptinezumab treatment (continuous variable)
Measured: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab
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 Apr 2025
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria Policlinico Modena, Società Italiana per lo Studio delle Cefalee, IRCCS National Neurological Institute "C. Mondino" Foundation, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, Università degli Studi dell'Aquila, University of Roma La Sapienza, Euganea Health Unit, Padua, Italy, 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
- NCT06409845
- Sponsor's protocol ID
- RICe_5
- Acronym
- TACHIS
- Status last verified
- May 2024
- 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
Dodick DW, Lipton RB, Silberstein S, Goadsby PJ, Biondi D, Hirman J, Cady R, Smith J. Eptinezumab for prevention of chronic migraine: A randomized phase 2b clinical trial. Cephalalgia. 2019 Aug;39(9):1075-1085. doi: 10.1177/0333102419858355. Epub 2019 Jun 24.
PubMed 31234642Winner PK, McAllister P, Chakhava G, Ailani J, Ettrup A, Krog Josiassen M, Lindsten A, Mehta L, Cady R. Effects of Intravenous Eptinezumab vs Placebo on Headache Pain and Most Bothersome Symptom When Initiated During a Migraine Attack: A Randomized Clinical Trial. JAMA. 2021 Jun 15;325(23):2348-2356. doi: 10.1001/jama.2021.7665.
PubMed 34128999Ashina M, Lanteri-Minet M, Pozo-Rosich P, Ettrup A, Christoffersen CL, Josiassen MK, Phul R, Sperling B. Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): a multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2022 Jul;21(7):597-607. doi: 10.1016/S1474-4422(22)00185-5.
PubMed 35716692Iannone LF, Piella EM, Montisano DA, Fasano C, Sebastianelli G, Coppola G, Ferrandi D, Lanni C, Prudenzano MP, de Tommaso M, Merlo P, De Cesaris F, Chiarugi A, Munafo A, Pistoia F, Ornello R, Doretti A, Grazzi L, Lo Castro F, De Icco R, Vaghi G, Avino G, Romozzi M, Calabresi P, Battistini S, Rufa A, Albanese M, Trimboli M, Carlucci G, Silvestro M, Russo A, Rainero I, Valente MR, Fofi L, Marcosano M, Geppetti P, Altamura C, Vernieri F, Tassorelli C, Sacco S, Guerzoni S; Italian Headache Registry (RICe) Study Group. Levels of migraine controls following International Headache Society (IHS) recommendations with eptinezumab: Effectiveness and tolerability in a 24-week, prospective multicenter study (the TACHIS study). Cephalalgia. 2026 Feb;46(2):3331024251414659. doi: 10.1177/03331024251414659. Epub 2026 Feb 12.
PubMed 41684106
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
- Effectiveness and Tolerability of Eptinezumab: a Prospective, Multicentric, Cohort Study
- ClinicalTrials.gov ID
- NCT06409845
- Acronym / sponsor ID
- TACHIS / RICe_5
- Conditions
- Migraine, Migraine With Aura, Migraine Without Aura, Chronic Migraine
- Keywords
- Headache, Medication overuse headache, Pain, Migraine prevention, Anti-CGRP monoclonal antibodies, eptinezumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria Policlinico Modena, Società Italiana per lo Studio delle Cefalee, IRCCS National Neurological Institute "C. Mondino" Foundation, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, Università degli Studi dell'Aquila, University of Roma La Sapienza, Euganea Health Unit, Padua, Italy, 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 Apr 2025 (actual)
- Study completion
- 1 Apr 2026 (actual)
- 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 eptinezumab as preventive migraine treatment in a cohort of episodic or chronic migraine patients.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Episodic migraine | – | Drug: Eptinezumab 100 or 300 mg evPatients affected by migraine with an episodic pattern (< 15 monthly migraine days) with or without aura according to ICHD-III criteria. |
| Chronic migraine | – | Drug: Eptinezumab 100 or 300 mg evatients affected by chronic migraine (> 15 monthly headache days with at least 8 days with migraine features) 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 eptinezumab use as migraine preventive treatment
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Eptinezumab 100 or 300 mg evAlso: EptinezumabPatients administered eptinezumab 100 or 300 mg ev quarterly for migraine prevention | Drug | Chronic migraine, Episodic migraine |
Primary outcome
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)
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)
13 secondary outcomes
Changes in migraine frequency across twelve months of eptinezumab treatment
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) across twelve months of treatment with eptinezumab
Time frame: 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
Evaluation of any adverse event (quantitative)
Time frame: 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
Evaluation of adverse events leading to treatment discontinuation
Time frame: 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
Changes in migraine disability (MIDAS)
Time frame: 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 response to acute migraine treatment (m-TOQ)
Time frame: 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 interictal burden across eptinezumab treatment (MIBS-4)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 31234642Dodick DW, Lipton RB, Silberstein S, Goadsby PJ, Biondi D, Hirman J, Cady R, Smith J. Eptinezumab for prevention of chronic migraine: A randomized phase 2b clinical trial. Cephalalgia. 2019 Aug;39(9):1075-1085. doi: 10.1177/0333102419858355. Epub 2019 Jun 24.
- Background: PubMed 34128999Winner PK, McAllister P, Chakhava G, Ailani J, Ettrup A, Krog Josiassen M, Lindsten A, Mehta L, Cady R. Effects of Intravenous Eptinezumab vs Placebo on Headache Pain and Most Bothersome Symptom When Initiated During a Migraine Attack: A Randomized Clinical Trial. JAMA. 2021 Jun 15;325(23):2348-2356. doi: 10.1001/jama.2021.7665.
- Background: PubMed 35716692Ashina M, Lanteri-Minet M, Pozo-Rosich P, Ettrup A, Christoffersen CL, Josiassen MK, Phul R, Sperling B. Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): a multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2022 Jul;21(7):597-607. doi: 10.1016/S1474-4422(22)00185-5.
- Derived from this study: PubMed 41684106Iannone LF, Piella EM, Montisano DA, Fasano C, Sebastianelli G, Coppola G, Ferrandi D, Lanni C, Prudenzano MP, de Tommaso M, Merlo P, De Cesaris F, Chiarugi A, Munafo A, Pistoia F, Ornello R, Doretti A, Grazzi L, Lo Castro F, De Icco R, Vaghi G, Avino G, Romozzi M, Calabresi P, Battistini S, Rufa A, Albanese M, Trimboli M, Carlucci G, Silvestro M, Russo A, Rainero I, Valente MR, Fofi L, Marcosano M, Geppetti P, Altamura C, Vernieri F, Tassorelli C, Sacco S, Guerzoni S; Italian Headache Registry (RICe) Study Group. Levels of migraine controls following International Headache Society (IHS) recommendations with eptinezumab: Effectiveness and tolerability in a 24-week, prospective multicenter study (the TACHIS study). Cephalalgia. 2026 Feb;46(2):3331024251414659. doi: 10.1177/03331024251414659. Epub 2026 Feb 12.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 1 site 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 5 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: finished, 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 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 eptinezumab (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 NCT06409845, which also lists 4 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.