A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients That Are Not Helped by Previous Preventive Treatments

Phase 1

• Conditions: Migraine in patients with unsuccessful prior preventive treatments; MedDRA version: 20.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-004497-25-PL
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-14
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 840

Inclusion Criteria

• The patient has a diagnosis of migraine, with a history of chronic or episodic migraines of at least 12 months prior to the Screening Visit.
• The patient has a migraine onset of =50 years of age.
• The patient has =4 migraine days per month for each month within the past 3 months prior to the Screening Visit.
• 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 fulfils the following criteria for chronic migraine (CM) or episodic migraine (EM) in prospectively collected information in the eDiary during the screening period:
– For patients with CM: Migraine occurring on =8 days and headache occurring on >14 days
– For patients with EM: Migraine occurring on =4 days and headache occurring on =14 days
• The patient has documented evidence of treatment failure (must be supported by medical record or by physician’s confirmation specific to each treatment) in the past 10 years of 2-4 different migraine preventive medications.
• The patient has a history of either previous or active use of triptans for migraine.
• The patient is aged =18 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 715
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 125

Exclusion Criteria

• The patient has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway.
• The patient has a treatment failure on valproate/divalproex or botulinum toxin A/B and the treatment is not the latest preventive medication prior to study inclusion. The medication is regarded as the latest if the medication start date is after the start date of the other preventive medications and the medication stop date is after the stop date of the other preventive medications.
• The patient has confounding and clinically significant pain syndromes, (e.g. 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, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
• The patient has a psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Patients with a lifetime history of psychosis and/or mania in the last 5 years prior to the Screening Visit are excluded.
• The patient has a history of clinically significant cardiovascular disease or vascular ischaemia or thromboembolic events (e.g. 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: • To evaluate the efficacy of eptinezumab for the prevention of migraine in patients with unsuccessful prior preventive treatments;Secondary Objective: • To evaluate the health-related quality of life and work productivity impact of eptinezumab<br>• To evaluate the effect of long-term treatment with eptinezumab;Primary end point(s): 1. Change from baseline in the number of monthly migraine days;Timepoint(s) of evaluation of this end point: 1. [Time Frame: From Baseline to Weeks 1-12]