Effectiveness and Tolerability of Eptinezumab: a Prospective, Multicentric, Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Eptinezumab 100 or 300 mg ev
- Conditions
- Migraine
- Sponsor
- University of Florence
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) after three months of treatment
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
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.
Investigators
Luigi Francesco Iannone
Researcher at the Headache Center and Clinical Pharmacology Unit and the Department of Health Sciences, University of Florence, Principal Investigator
University of Florence
Eligibility Criteria
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
Arms & Interventions
Episodic migraine
Patients affected by migraine with an episodic pattern (\< 15 monthly migraine days) with or without aura according to ICHD-III criteria.
Intervention: 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.
Intervention: Eptinezumab 100 or 300 mg ev
Outcomes
Primary Outcomes
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)
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)
Secondary Outcomes
- Changes in migraine frequency across twelve months of eptinezumab treatment(Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab)
- Changes in migraine disability (MIDAS)(3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab)
- Changes in migraine disability (HIT-6)(3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab)
- Consistency of treatment response(3 months (T3) - 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)
- 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 serious adverse events(3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab)
- Evaluation of adverse events leading to treatment discontinuation(3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab)
- Changes in response to acute migraine treatment (m-TOQ)(3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab)
- Changes in allodynia (ASC-12)(3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab)
- Changes in interictal burden across eptinezumab treatment (MIBS-4)(3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab)
- Percentage of patients with Medication overuse headache reverted during treatment(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)