A Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Participants Experiencing Acute Attack of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Eptinezumab; Placebo
Intervention description: Injection for IV administration; Injection for IV administration
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 485.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of eptinezumab administered
      intravenously in participants experiencing an acute attack of migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Greater than 1-year history of migraine, with or without aura, with onset of first
             migraine before age 50.

          -  Migraine on 4 to 15 days per month in the 3 months prior to screening.

          -  Headache free for at least 24 hours prior to onset of a qualifying migraine.

        Exclusion Criteria:

          -  Unable to differentiate migraine from other headache or pain disorders.

          -  Use of the following medication, for any indication, within the 24-hour period prior
             to dosing with study drug:

               1. triptans, ergotamines and ergot-derivatives

               2. analgesics (including but not limited to acetaminophen, tramadol, nonsteroidal
                  anti-inflammatory drugs [NSAIDs], combination analgesics, caffeine-containing
                  analgesics, and opioids/narcotics) and other acute migraine medication(s)

               3. antiemetic medications (including but not limited to prochlorperazine,
                  promethazine, droperidol, chlorpromazine, metoclopramide)

               4. antihistamines

               5. devices, neuromodulation, neurostimulation, or injectable therapy (trigger point
                  injections, extracranial nerve blocks, facet joint injections, spinal
                  manipulation)

          -  Use of the following medication, for any indication, in each of the 3 months prior to
             screening:

               1. opioids/narcotics or butalbital containing products (including combinations) on
                  more than 4 days per month;

               2. triptans, ergotamines, or combination analgesics for 10 or more days per month;

               3. acetaminophen, aspirin or NSAIDs for 15 or more days per month (except if
                  participant is taking 81 mg dose of aspirin for cardiac prophylaxis)

          -  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
             (for example, diplopia, altered consciousness, or long duration).

          -  Any changes to preventive migraine treatment(s) within 1 month prior to screening and
             up to treatment with the study drug (Day 0).

          -  Any use of approved devices, neuromodulation, neurostimulation, or injectable therapy
             (trigger point injections, extracranial nerve blocks, facet joint injections) within
             the 24-hour period prior to treatment with study drug (Day 0).

          -  Any use of botulinum toxin for migraine or for any other medical/cosmetic reasons
             requiring injections within 7 days prior to treatment with study drug (Day 0).

          -  Any use of systemic corticosteroid for migraine or any other reason within 3 months
             prior to treatment with study drug (Day 0).

          -  Evidence or medical history of clinically significant psychiatric diseases that are
             uncontrolled and/or untreated.

          -  Receipt of any monoclonal antibody treatment, for migraine or any other indication,
             (within or outside a clinical study) within 6 months prior to screening.