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

NCT04152083 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: ALD403-CLIN-01518903A
• Study Type: interventional
• Target: 485
• Locations: 2 countries
• Sites: 57

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Headache Pain Freedom at 2 Hours

  2 hours

• Absence of MBS at 2 Hours

  2 hours

• Headache Pain Freedom at 4 Hours

  4 hours

• Absence of MBS at 4 Hours

  4 hours

• Use of Rescue Medication Within the First 24 Hours

  Up to 24 hours postdose

Study Arms (2)

Eptinezumab

EXPERIMENTAL

Participants will receive a single dose of eptinezumab 100 milligrams (mg) administered via intravenous (IV) infusion on Day 0.

Drug: Eptinezumab

Placebo

PLACEBO COMPARATOR

Participants will receive a single dose of placebo matching to eptinezumab administered via IV infusion on Day 0.

Drug: Placebo

Interventions

Eptinezumab DRUG

Injection for IV administration

Eptinezumab

Placebo DRUG

Injection for IV administration

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• H. Lundbeck A/S: lead
• Alder Biopharmaceuticals, Inc.: collaborator

Study Sites (57)

Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States

Location

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Baptist Health Center for Clinical Research

Little Rock, Arkansas, 72205, United States

Location

Advanced Research Center

Anaheim, California, 92805, United States

Location

The Neurology Center of Southern California - Carlsbad

Carlsbad, California, 92011, United States

Location

Excell research Inc

Oceanside, California, 92056, United States

Location

Anderson Clinical Research

Redlands, California, 92374, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Denver Neurological Clinic - Denver

Denver, Colorado, 80210, United States

Location

Coastal Connecticut Research LLC

New London, Connecticut, 06320, United States

Location

Ki Health Partners LLC, dba New England Institute for Clinical Research

Stamford, Connecticut, 06905, United States

Location

The George Washington Medical Faculty Associates

Washington D.C., District of Columbia, 20052, United States

Location

Medicinae Doctor Clinical

Hallandale, Florida, 33009, United States

Location

AGA Clinical trials

Hialeah, Florida, 33012, United States

Location

Meridien Research - Maitland

Maitland, Florida, 32751, United States

Location

Palm Beach Neurology and Premiere Research Institute

West Palm Beach, Florida, 33407, United States

Location

Clinical Research of Central Florida

Winter Haven, Florida, 33880, United States

Location

Office of Doctor Frank Berenson

Atlanta, Georgia, 30328, United States

Location

iResearch Atlanta, LLC

Decatur, Georgia, 30030, United States

Location

Meridian Clinical Research - Savannah Neurology Specialists

Savannah, Georgia, 31405, United States

Location

Cedar Crosse Research Center

Chicago, Illinois, 60607, United States

Location

College Park Family Care Center Physicians

Overland Park, Kansas, 66212, United States

Location

Phoenix Medical Research

Prairie Village, Kansas, 66208, United States

Location

Central Kentucky Research Associates

Lexington, Kentucky, 40509, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

MedVadis Research Corporation, LLC

Waltham, Massachusetts, 02451, United States

Location

Michigan Head Pain and Neurological institute

Ann Arbor, Michigan, 48104, United States

Location

Clinical Research Institute - Minneapolis

Minneapolis, Minnesota, 55402, United States

Location

Headache Neurology Research Institute

Ridgeland, Mississippi, 39157, United States

Location

StudyMetrix Research

City of Saint Peters, Missouri, 63303, United States

Location

Clinvest Research

Springfield, Missouri, 65810, United States

Location

Nevada Headache Institute

Las Vegas, Nevada, 89113, United States

Location

Albuqerque Clinical Trials

Albuquerque, New Mexico, 87102, United States

Location

Dent Neurologic Institute - Amherst

Amherst, New York, 14226, United States

Location

Integrative Clinical Trials

Brooklyn, New York, 11229, United States

Location

CTI Clinical Research center

Cincinnati, Ohio, 45212, United States

Location

Aventiv Research - Columbus

Columbus, Ohio, 43213, United States

Location

Hometown Urgent Care And Research - Huber Heights

Dayton, Ohio, 45424, United States

Location

Neuro-Behavioral Clinical Research Inc

North Canton, Ohio, 44720, United States

Location

Delricht Research

Tulsa, Oklahoma, 74133, United States

Location

Summit Research Network

Portland, Oregon, 97210, United States

Location

Frontier Clinical Rsearch LLC

Smithfield, Pennsylvania, 15478, United States

Location

Coastal Carolina Research Center - Mount Pleasant

Mt. Pleasant, South Carolina, 29464, United States

Location

Chattanooga Medical research LLC

Chattanooga, Tennessee, 37404, United States

Location

WR-ClinSearch LLC

Chattanooga, Tennessee, 37421, United States

Location

Holston Medical Group - Kingsport

Kingsport, Tennessee, 37660, United States

Location

Ventavia Research Group, LLC

Fort Worth, Texas, 76104, United States

Location

Texas Center for Drug Development Inc

Houston, Texas, 77081, United States

Location

Ventavia Research Group, LLC

Keller, Texas, 76248, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Neuroscience Group

Neenah, Wisconsin, 54956, United States

Location

Ltd "Acad Fridon Todua Medical Center - Ltd Research Institute of Clinical Medicine"

Tbilisi, Georgia

Location

Ltd "Aversi Clinic"

Tbilisi, Georgia

Location

Ltd "Multiprofile Clinica Consilium Medulla"

Tbilisi, Georgia

Location

Ltd Simon Khechinashvili University Clinic

Tbilisi, Georgia

Location

td "Israel-Georgia Medical Research Clinic Helsicore"

Tbilisi, Georgia

Location

Related Publications (4)

• Cady R, Lipton RB, Buse DC, Josiassen MK, Lindsten A, Ettrup A. Optimization of acute medication use following eptinezumab initiation during a migraine attack: post hoc analysis of the RELIEF study. J Headache Pain. 2022 Jul 28;23(1):91. doi: 10.1186/s10194-022-01463-3.

  PMID: 35902796 DERIVED

• Ailani J, McAllister P, Winner PK, Chakhava G, Krog Josiassen M, Lindsten A, Sperling B, Ettrup A, Cady R. Rapid resolution of migraine symptoms after initiating the preventive treatment eptinezumab during a migraine attack: results from the randomized RELIEF trial. BMC Neurol. 2022 Jun 3;22(1):205. doi: 10.1186/s12883-022-02714-1.

  PMID: 35659622 DERIVED

• McAllister P, Winner PK, Ailani J, Buse DC, Lipton RB, Chakhava G, Josiassen MK, Lindsten A, Mehta L, Ettrup A, Cady R. Eptinezumab treatment initiated during a migraine attack is associated with meaningful improvement in patient-reported outcome measures: secondary results from the randomized controlled RELIEF study. J Headache Pain. 2022 Feb 7;23(1):22. doi: 10.1186/s10194-021-01376-7.

  PMID: 35130832 DERIVED

• Winner PK, McAllister P, Chakhava G, Ailani J, Ettrup A, Krog Josiassen M, Lindsten A, Mehta L, Cady R. Effects of Intravenous Eptinezumab vs Placebo on Headache Pain and Most Bothersome Symptom When Initiated During a Migraine Attack: A Randomized Clinical Trial. JAMA. 2021 Jun 15;325(23):2348-2356. doi: 10.1001/jama.2021.7665.

  PMID: 34128999 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

eptinezumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Email contact via
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@Lundbeck.com

+4536301311

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2019
• First Posted: November 5, 2019
• Study Start: November 7, 2019
• Primary Completion: July 8, 2020
• Study Completion: July 8, 2020
• Last Updated: August 17, 2021
• Results First Posted: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GE (5); US (52)