Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine

Phase 1

• Conditions: Chronic migraine; MedDRA version: 21.1Level: LLTClassification code 10066636Term: Chronic migraineSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-001657-42-ES
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-21
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 513

Inclusion Criteria

• The patient has a diagnosis of CM as defined by IHS ICHD-3 guidelines confirmed at screening visit with a history of migraine onset at least 12 months prior to the Screening Visit.
• The patient has had a diagnosis of migraine at <50 years of age.
• The patient has =8 migraine days per month for each month within the past 3 months prior to the Screening Visit.
• The patient fulfils the following criteria for migraine in prospectively collected information in the eDiary during the screening period:
• Migraine occurring on =8 days and headache occurring on =15 to =26 days.
• The patient has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days following the Screening Visit.
• The patient is aged =18 (=20 for Taiwan) and =75 years at the Screening Visit.

Other inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 113

Exclusion Criteria

• The patient has received any medication targeting the calcitonin generelated peptide (CGRP) pathway as preventive treatment of migraine.
• The patient has confounding and clinically significant pain syndromes, (for example, fibromyalgia, chronic low back pain, complex regional pain
syndrome).
• The patient has a diagnosis of acute or active temporomandibular disorder.
• The patient has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily
persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), ophthalmoplegic migraine, migraine with brainstem aura and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
• The patient has a lifetime history of psychosis, bipolar mania, or dementia.
• Patients with other psychiatric conditions whose symptoms are not controlled or who have not been adequately treated for a minimum of 6 months prior to screening are also excluded.
• The patient has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, vascular ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).

Other exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study evaluates the efficacy of eptinezumab to prevent migraine in patients with chronic migraine;Secondary Objective: Not applicable;Primary end point(s): 1. Change from baseline in the number of monthly migraine days (MMDs);Timepoint(s) of evaluation of this end point: 1. Weeks 1-12