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

NCT ID: NCT04152083

Last Updated: 2021-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 485 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-07
• Study Completion Date: 2020-07-08

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Eptinezumab

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

Group Type: EXPERIMENTAL

Eptinezumab

Intervention Type: DRUG

Injection for IV administration

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Injection for IV administration

Interventions

Eptinezumab

Injection for IV administration

Intervention Type: DRUG

Placebo

Injection for IV administration

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alder Biopharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@lundbeck.com

Locations

Alabama Clinical Therapeutics

Birmingham, Alabama, United States

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

MedVadis Research Corporation, LLC

Waltham, Massachusetts, United States

Michigan Head Pain and Neurological institute

Ann Arbor, Michigan, United States

Clinical Research Institute - Minneapolis

Minneapolis, Minnesota, United States

Headache Neurology Research Institute

Ridgeland, Mississippi, United States

StudyMetrix Research

City of Saint Peters, Missouri, United States

Clinvest Research

Springfield, Missouri, United States

Nevada Headache Institute

Las Vegas, Nevada, United States

Albuqerque Clinical Trials

Albuquerque, New Mexico, United States

Dent Neurologic Institute - Amherst

Amherst, New York, United States

Integrative Clinical Trials

Brooklyn, New York, 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

Neuro-Behavioral Clinical Research Inc

North Canton, Ohio, United States

Delricht Research

Tulsa, Oklahoma, United States

Summit Research Network

Portland, Oregon, United States

Frontier Clinical Rsearch LLC

Smithfield, Pennsylvania, United States

Coastal Carolina Research Center - Mount Pleasant

Mt. Pleasant, South Carolina, United States

Chattanooga Medical research LLC

Chattanooga, Tennessee, United States

WR-ClinSearch LLC

Chattanooga, Tennessee, United States

Holston Medical Group - Kingsport

Kingsport, Tennessee, United States

Ventavia Research Group, LLC

Fort Worth, Texas, United States

Texas Center for Drug Development Inc

Houston, Texas, United States

Ventavia Research Group, LLC

Keller, Texas, United States

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Neuroscience Group

Neenah, Wisconsin, United States

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, , Georgia

Countries

United States; Georgia

References

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.

Reference Type: DERIVED

PMID: 35902796 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35659622 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35130832 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34128999 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

18903A

Identifier Type: OTHER

Identifier Source: secondary_id

ALD403-CLIN-015

Identifier Type: -

Identifier Source: org_study_id