Effectiveness and Tolerability of Eptinezumab

NCT06409845 | Recruiting DMC

• 1 other identifier: RICe_5
• 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 eptinezumab as preventive migraine treatment in a cohort of episodic or chronic migraine patients.

Conditions

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

Keywords

Headache; Medication overuse headache; Pain; Migraine prevention; Anti-CGRP monoclonal antibodies; eptinezumab

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 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

  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 Outcomes (13)

• Changes in migraine frequency across twelve months of eptinezumab treatment

  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

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

• Evaluation of any adverse event (qualitative)

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

• Evaluation of any adverse event (quantitative)

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

• Evaluation of serious adverse events

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

Other Outcomes (12)

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

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

• Variation of duration of aura (qualitative)

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

• Variation of type of aura (qualitative)

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

Study Arms (2)

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

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

Interventions

Eptinezumab 100 or 300 mg ev DRUG

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

Also known as: Eptinezumab

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florence: lead
• Azienda Ospedaliero Universitaria Policlinico Modena: collaborator
• Società Italiana per lo Studio delle Cefalee: collaborator
• IRCCS National Neurological Institute "C. Mondino" Foundation: collaborator
• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: collaborator
• Università degli Studi dell'Aquila: collaborator
• University of Roma La Sapienza: collaborator
• Euganea Health Unit, Padua, Italy: 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
• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: collaborator

Study Sites (2)

SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi

Florence, 50134, Italy

RECRUITING

AOU Policlinico Di Modena

Modena, 41124, Italy

NOT YET RECRUITING

Related Publications (3)

• 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.

  PMID: 31234642 BACKGROUND

• Winner 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.

  PMID: 34128999 BACKGROUND

• Ashina 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.

  PMID: 35716692 BACKGROUND

MeSH Terms

Conditions

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

Interventions

eptinezumab

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

3896969606; luigifrancesco.iannone@unifi.it

Simona Guerzoni, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• 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: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

IT (2)