A Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Participants Experiencing Acute Attack of Migraine

Completed · Phase 3 · Has a placebo group

Conditions studied: Migraine

In brief

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

Key facts

Study ID

NCT04152083

Run by

H. Lundbeck A/S

People needed

485

Starts

2019-11-07

Expected to finish

2020-07-08

Last updated by the study team

2021-08-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• triptans, ergotamines and ergot-derivatives
• 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)
• antiemetic medications (including but not limited to prochlorperazine, promethazine, droperidol, chlorpromazine, metoclopramide)
• antihistamines
• 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:
• opioids/narcotics or butalbital containing products (including combinations) on more than 4 days per month;
• triptans, ergotamines, or combination analgesics for 10 or more days per month;
• 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.

Where it is running

• Arizona Research Center — Phoenix, Arizona, United States
• Baptist Health Center for Clinical Research — Little Rock, Arkansas, United States
• Advanced Research Center — Anaheim, California, United States
• The Neurology Center of Southern California - Carlsbad — Carlsbad, California, United States
• Excell research Inc — Oceanside, California, United States
• Anderson Clinical Research — Redlands, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Denver Neurological Clinic - Denver — Denver, Colorado, United States
• Coastal Connecticut Research LLC — New London, Connecticut, United States
• Ki Health Partners LLC, dba New England Institute for Clinical Research — Stamford, Connecticut, United States
• The George Washington Medical Faculty Associates — Washington D.C., District of Columbia, United States
• Medicinae Doctor Clinical — Hallandale, Florida, United States
• AGA Clinical trials — Hialeah, Florida, United States
• Meridien Research - Maitland — Maitland, Florida, United States
• Palm Beach Neurology and Premiere Research Institute — West Palm Beach, Florida, United States
• Clinical Research of Central Florida — Winter Haven, Florida, United States
• Office of Doctor Frank Berenson — Atlanta, Georgia, United States
• iResearch Atlanta, LLC — Decatur, Georgia, United States
• Meridian Clinical Research - Savannah Neurology Specialists — Savannah, Georgia, United States
• Cedar Crosse Research Center — Chicago, Illinois, United States
• College Park Family Care Center Physicians — Overland Park, Kansas, United States
• Phoenix Medical Research — Prairie Village, Kansas, United States
• Central Kentucky Research Associates — Lexington, Kentucky, United States
• Boston Clinical Trials — Boston, Massachusetts, United States
• Alabama Clinical Therapeutics — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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