A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Eptinezumab; Placebo
Intervention description: Eptinezumab, concentrate for solution for infusion 100 mg/milliliter (mL); concentrate for solution for infusion, intravenously
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 892.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Evaluation of eptinezumab in the prevention of migraine in participants with unsuccessful
      prior preventive treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant has a diagnosis of migraine, with a history of chronic or episodic
             migraines of at least 12 months prior to the Screening Visit

          -  The participant has a migraine onset of ≤50 years of age.

          -  The participant has ≥4 migraine days per month for each month within the past 3 months
             prior to the Screening Visit.

          -  The participant has demonstrated compliance with the Headache eDiary by entry of data
             for at least 24 of the 28 days following the Screening Visit.

          -  The participant fulfils the following criteria for chronic migraine (CM) or episodic
             migraine (EM) in prospectively collected information in the eDiary during the
             screening period:

          -  For participants with CM: Migraine occurring on ≥8 days and headache occurring on >14
             days

          -  For participants with EM: Migraine occurring on ≥4 days and headache occurring on ≤14
             days

          -  The participant 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 participant has a history of either previous or active use of triptans for
             migraine.

        Exclusion Criteria:

          -  The participant has experienced failure on a previous treatment targeting the
             calcitonin gene-related peptide (CGRP) pathway.

          -  The participant 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 participant has confounding and clinically significant pain syndromes, (for
             example, fibromyalgia, chronic low back pain, complex regional pain syndrome).

          -  The participant has a diagnosis of acute or active temporomandibular disorder.

          -  The participant 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 participant has a psychiatric condition that is uncontrolled and/or untreated for
             a minimum of 6 months prior to the Screening Visit. Participants with a lifetime
             history of psychosis and/or mania in the last 5 years prior to the Screening Visit are
             excluded.

          -  The participant has a history of clinically significant cardiovascular disease or
             vascular ischaemia or thromboembolic events (for example, cerebrovascular accident,
             deep vein thrombosis, or pulmonary embolism).

        Other in- and exclusion criteria may apply