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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04152083
Other study ID # ALD403-CLIN-015
Secondary ID 18903A
Status Completed
Phase Phase 3
First received
Last updated
Start date November 7, 2019
Est. completion date July 8, 2020

Study information

Verified date August 2021
Source H. Lundbeck A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 485
Est. completion date July 8, 2020
Est. primary completion date July 8, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Eptinezumab
Injection for IV administration
Placebo
Injection for IV administration

Locations

Country Name City State
Georgia Ltd "Acad Fridon Todua Medical Center - Ltd Research Institute of Clinical Medicine" Tbilisi
Georgia Ltd "Aversi Clinic" Tbilisi
Georgia Ltd "Multiprofile Clinica Consilium Medulla" Tbilisi
Georgia Ltd Simon Khechinashvili University Clinic Tbilisi
Georgia td "Israel-Georgia Medical Research Clinic Helsicore" Tbilisi
United States Albuqerque Clinical Trials Albuquerque New Mexico
United States Dent Neurologic Institute - Amherst Amherst New York
United States Advanced Research Center Anaheim California
United States Michigan Head Pain and Neurological institute Ann Arbor Michigan
United States Office of Doctor Frank Berenson Atlanta Georgia
United States University of Colorado Hospital Aurora Colorado
United States Northwest Clinical Research Center Bellevue Washington
United States Alabama Clinical Therapeutics Birmingham Alabama
United States Boston Clinical Trials Boston Massachusetts
United States Integrative Clinical Trials Brooklyn New York
United States The Neurology Center of Southern California - Carlsbad Carlsbad California
United States Chattanooga Medical research LLC Chattanooga Tennessee
United States WR-ClinSearch LLC Chattanooga Tennessee
United States Cedar Crosse Research Center Chicago Illinois
United States CTI Clinical Research center Cincinnati Ohio
United States Aventiv Research - Columbus Columbus Ohio
United States Hometown Urgent Care And Research - Huber Heights Dayton Ohio
United States iResearch Atlanta, LLC Decatur Georgia
United States Denver Neurological Clinic - Denver Denver Colorado
United States Ventavia Research Group, LLC Fort Worth Texas
United States Medicinae Doctor Clinical Hallandale Beach Florida
United States AGA Clinical trials Hialeah Florida
United States Texas Center for Drug Development Inc Houston Texas
United States Ventavia Research Group, LLC Keller Texas
United States Holston Medical Group - Kingsport Kingsport Tennessee
United States Nevada Headache Institute Las Vegas Nevada
United States Central Kentucky Research Associates Lexington Kentucky
United States Baptist Health Center for Clinical Research Little Rock Arkansas
United States Meridien Research - Maitland Maitland Florida
United States Clinical Research Institute - Minneapolis Minneapolis Minnesota
United States Coastal Carolina Research Center - Mount Pleasant Mount Pleasant South Carolina
United States Neuroscience Group Neenah Wisconsin
United States Coastal Connecticut Research LLC New London Connecticut
United States Neuro-Behavioral Clinical Research Inc North Canton Ohio
United States Excell research Inc Oceanside California
United States College Park Family Care Center Physicians Overland Park Kansas
United States Arizona Research Center Phoenix Arizona
United States Summit Research Network Portland Oregon
United States Phoenix Medical Research Prairie Village Kansas
United States Anderson Clinical Research Redlands California
United States Headache Neurology Research Institute Ridgeland Mississippi
United States StudyMetrix Research Saint Peters Missouri
United States J. Lewis Research, Inc. / Foothill Family Clinic Salt Lake City Utah
United States Meridian Clinical Research - Savannah Neurology Specialists Savannah Georgia
United States Frontier Clinical Rsearch LLC Smithfield Pennsylvania
United States Clinvest Research Springfield Missouri
United States Ki Health Partners LLC, dba New England Institute for Clinical Research Stamford Connecticut
United States Delricht Research Tulsa Oklahoma
United States MedVadis Research Corporation, LLC Waltham Massachusetts
United States The George Washington Medical Faculty Associates Washington District of Columbia
United States Palm Beach Neurology and Premiere Research Institute West Palm Beach Florida
United States Clinical Research of Central Florida Winter Haven Florida

Sponsors (2)

Lead Sponsor Collaborator
H. Lundbeck A/S Alder Biopharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Georgia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to Headache Pain Freedom 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. Up to 48 hours postdose
Primary Time to Absence of Most Bothersome Symptom (MBS) Time to absence of most bothersome symptom defined as the time that the participant reported absence of MBS (of nausea, photophobia, or phonophobia). Up to 48 hours postdose
Secondary Headache Pain Freedom at 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. 2 hours
Secondary Absence of MBS at 2 Hours Number of participants with absence of MBS (of nausea, photophobia, or phonophobia) at 2 hours postdose are reported. 2 hours
Secondary Headache Pain Freedom at 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. 4 hours
Secondary Absence of MBS at 4 Hours Number of participants with absence of MBS (of nausea, photophobia, or phonophobia) at 4 hours postdose are reported. 4 hours
Secondary Use of Rescue Medication Within the First 24 Hours 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. Up to 24 hours postdose
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