A Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Participants Experiencing Acute Attack of Migraine
- Registration Number
- NCT04152083
- Lead Sponsor
- H. Lundbeck A/S
- Brief 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.
- Detailed Description
This will be a parallel group, double-blind, randomized, placebo-controlled study assessing the efficacy of eptinezumab for acute migraine, defined as an active intercurrent migraine occurring in those participants who are candidates for preventive therapy. Participants will be randomized to receive a single dose of eptinezumab or placebo in a 1:1 ratio. The total study duration will be approximately 4 to 12 weeks, including up to an 8-week screening period and 4-week of safety follow-up, with clinic visits occurring on Screening, Day 0 (dosing day), and Week 4.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 485
- 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.
-
Unable to differentiate migraine from other headache or pain disorders.
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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)
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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).
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Any changes to preventive migraine treatment(s) within 1 month prior to screening and up to treatment with the study drug (Day 0).
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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).
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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.
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Receipt of any monoclonal antibody treatment, for migraine or any other indication, (within or outside a clinical study) within 6 months prior to screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive a single dose of placebo matching to eptinezumab administered via IV infusion on Day 0. Eptinezumab Eptinezumab Participants will receive a single dose of eptinezumab 100 milligrams (mg) administered via intravenous (IV) infusion on Day 0.
- Primary Outcome Measures
Name Time Method Time to Absence of Most Bothersome Symptom (MBS) Up to 48 hours postdose Time to absence of most bothersome symptom defined as the time that the participant reported absence of MBS (of nausea, photophobia, or phonophobia).
Time to Headache Pain Freedom Up to 48 hours postdose Time to headache pain freedom defined as the time that the participant reported freedom of pain, meaning their headache pain had gone from moderate to severe at baseline to no pain.
- Secondary Outcome Measures
Name Time Method Headache Pain Freedom at 4 Hours 4 hours Number of participants with freedom from headache pain at 4 hours postdose are reported. Freedom from headache pain meaning that the headache pain that had gone from moderate to severe at baseline to no pain with no administration of rescue medications.
Absence of MBS at 4 Hours 4 hours Number of participants with absence of MBS (of nausea, photophobia, or phonophobia) at 4 hours postdose are reported.
Headache Pain Freedom at 2 Hours 2 hours Number of participants with freedom from headache pain at 2 hours postdose are reported. Freedom from headache pain meaning that the headache pain that had gone from moderate to severe at baseline to no pain with no administration of rescue medications.
Absence of MBS at 2 Hours 2 hours Number of participants with absence of MBS (of nausea, photophobia, or phonophobia) at 2 hours postdose are reported.
Use of Rescue Medication Within the First 24 Hours Up to 24 hours postdose Rescue medication was defined as any medication to treat migraine or migraine-associated symptoms, which could have been provided to the participant any time after 2 hours post-start of infusion. Use of rescue medication was captured in the eDiary. Number of participants who used rescue medication up to 24 hours postdose are reported.
Trial Locations
- Locations (56)
Aventiv Research - Columbus
🇺🇸Columbus, Ohio, United States
Neuro-Behavioral Clinical Research Inc
🇺🇸North Canton, Ohio, United States
Excell research Inc
🇺🇸Oceanside, California, United States
Anderson Clinical Research
🇺🇸Redlands, California, United States
Advanced Research Center
🇺🇸Anaheim, California, United States
Office of Doctor Frank Berenson
🇺🇸Atlanta, Georgia, United States
Integrative Clinical Trials
🇺🇸Brooklyn, New York, United States
Palm Beach Neurology and Premiere Research Institute
🇺🇸West Palm Beach, Florida, United States
Clinvest Research
🇺🇸Springfield, Missouri, United States
Albuqerque Clinical Trials
🇺🇸Albuquerque, New Mexico, United States
Hometown Urgent Care And Research - Huber Heights
🇺🇸Dayton, Ohio, United States
Texas Center for Drug Development Inc
🇺🇸Houston, Texas, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Clinical Research Institute - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
J. Lewis Research, Inc. / Foothill Family Clinic
🇺🇸Salt Lake City, Utah, United States
Phoenix Medical Research
🇺🇸Prairie Village, Kansas, United States
Baptist Health Center for Clinical Research
🇺🇸Little Rock, Arkansas, United States
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
CTI Clinical Research center
🇺🇸Cincinnati, Ohio, United States
Alabama Clinical Therapeutics
🇺🇸Birmingham, Alabama, United States
Ltd "Multiprofile Clinica Consilium Medulla"
🇬🇪Tbilisi, Georgia
td "Israel-Georgia Medical Research Clinic Helsicore"
🇬🇪Tbilisi, Georgia
Medicinae Doctor Clinical
🇺🇸Hallandale Beach, Florida, United States
Coastal Carolina Research Center - Mount Pleasant
🇺🇸Mount Pleasant, South Carolina, United States
Ki Health Partners LLC, dba New England Institute for Clinical Research
🇺🇸Stamford, Connecticut, United States
Coastal Connecticut Research LLC
🇺🇸New London, Connecticut, United States
The George Washington Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
Ltd Simon Khechinashvili University Clinic
🇬🇪Tbilisi, Georgia
Headache Neurology Research Institute
🇺🇸Ridgeland, Mississippi, United States
WR-ClinSearch LLC
🇺🇸Chattanooga, Tennessee, United States
Chattanooga Medical research LLC
🇺🇸Chattanooga, Tennessee, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Neuroscience Group
🇺🇸Neenah, Wisconsin, United States
AGA Clinical trials
🇺🇸Hialeah, Florida, United States
Clinical Research of Central Florida
🇺🇸Winter Haven, Florida, United States
Ltd "Aversi Clinic"
🇬🇪Tbilisi, Georgia
Holston Medical Group - Kingsport
🇺🇸Kingsport, Tennessee, United States
Nevada Headache Institute
🇺🇸Las Vegas, Nevada, United States
Meridien Research - Maitland
🇺🇸Maitland, Florida, United States
MedVadis Research Corporation, LLC
🇺🇸Waltham, Massachusetts, United States
Ltd "Acad Fridon Todua Medical Center - Ltd Research Institute of Clinical Medicine"
🇬🇪Tbilisi, Georgia
Denver Neurological Clinic - Denver
🇺🇸Denver, Colorado, United States
Summit Research Network
🇺🇸Portland, Oregon, United States
The Neurology Center of Southern California - Carlsbad
🇺🇸Carlsbad, California, United States
iResearch Atlanta, LLC
🇺🇸Decatur, Georgia, United States
Cedar Crosse Research Center
🇺🇸Chicago, Illinois, United States
Dent Neurologic Institute - Amherst
🇺🇸Amherst, New York, United States
Meridian Clinical Research - Savannah Neurology Specialists
🇺🇸Savannah, Georgia, United States
Delricht Research
🇺🇸Tulsa, Oklahoma, United States
Ventavia Research Group, LLC
🇺🇸Keller, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Frontier Clinical Rsearch LLC
🇺🇸Smithfield, Pennsylvania, United States
College Park Family Care Center Physicians
🇺🇸Overland Park, Kansas, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Central Kentucky Research Associates
🇺🇸Lexington, Kentucky, United States
Michigan Head Pain and Neurological institute
🇺🇸Ann Arbor, Michigan, United States