- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04152083
A Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Participants Experiencing Acute Attack of Migraine (RELIEF)
August 13, 2021 updated by: H. Lundbeck A/S
A Parallel Group, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Subjects Experiencing an Acute Attack of Migraine
The purpose of this study is to evaluate the efficacy and safety of eptinezumab administered intravenously in participants experiencing an acute attack of migraine.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
485
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tbilisi, 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"
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35235
- Alabama Clinical Therapeutics
-
-
Arizona
-
Phoenix, Arizona, United States, 85053
- Arizona Research Center
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- Baptist Health Center for Clinical Research
-
-
California
-
Anaheim, California, United States, 92805
- Advanced Research Center
-
Carlsbad, California, United States, 92011
- The Neurology Center of Southern California - Carlsbad
-
Oceanside, California, United States, 92056
- Excell Research Inc
-
Redlands, California, United States, 92374
- Anderson Clinical Research
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Hospital
-
Denver, Colorado, United States, 80210
- Denver Neurological Clinic - Denver
-
-
Connecticut
-
New London, Connecticut, United States, 06320
- Coastal Connecticut Research LLC
-
Stamford, Connecticut, United States, 06905
- Ki Health Partners LLC, dba New England Institute for Clinical Research
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20052
- The George Washington Medical Faculty Associates
-
-
Florida
-
Hallandale Beach, Florida, United States, 33009
- Medicinae Doctor Clinical
-
Hialeah, Florida, United States, 33012
- AGA Clinical Trials
-
Maitland, Florida, United States, 32751
- Meridien Research - Maitland
-
West Palm Beach, Florida, United States, 33407
- Palm Beach Neurology and Premiere Research Institute
-
Winter Haven, Florida, United States, 33880
- Clinical Research of Central Florida
-
-
Georgia
-
Atlanta, Georgia, United States, 30328
- Office of Doctor Frank Berenson
-
Decatur, Georgia, United States, 30030
- iResearch Atlanta, LLC
-
Savannah, Georgia, United States, 31405
- Meridian Clinical Research - Savannah Neurology Specialists
-
-
Illinois
-
Chicago, Illinois, United States, 60607
- Cedar Crosse Research Center
-
-
Kansas
-
Overland Park, Kansas, United States, 66212
- College Park Family Care Center Physicians
-
Prairie Village, Kansas, United States, 66208
- Phoenix Medical Research
-
-
Kentucky
-
Lexington, Kentucky, United States, 40509
- Central Kentucky Research Associates
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02131
- Boston Clinical Trials
-
Waltham, Massachusetts, United States, 02451
- MedVadis Research Corporation, LLC
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48104
- Michigan Head Pain and Neurological Institute
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55402
- Clinical Research Institute - Minneapolis
-
-
Mississippi
-
Ridgeland, Mississippi, United States, 39157
- Headache Neurology Research Institute
-
-
Missouri
-
Saint Peters, Missouri, United States, 63303
- StudyMetrix Research
-
Springfield, Missouri, United States, 65810
- Clinvest Research
-
-
Nevada
-
Las Vegas, Nevada, United States, 89113
- Nevada Headache Institute
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87102
- Albuqerque Clinical Trials
-
-
New York
-
Amherst, New York, United States, 14226
- Dent Neurologic Institute - Amherst
-
Brooklyn, New York, United States, 11229
- Integrative Clinical Trials
-
-
Ohio
-
Cincinnati, Ohio, United States, 45212
- CTI Clinical Research Center
-
Columbus, Ohio, United States, 43213
- Aventiv Research - Columbus
-
Dayton, Ohio, United States, 45424
- Hometown Urgent Care and Research - Huber Heights
-
North Canton, Ohio, United States, 44720
- Neuro-Behavioral Clinical Research Inc
-
-
Oklahoma
-
Tulsa, Oklahoma, United States, 74133
- DelRicht Research
-
-
Oregon
-
Portland, Oregon, United States, 97210
- Summit Research Network
-
-
Pennsylvania
-
Smithfield, Pennsylvania, United States, 15478
- Frontier Clinical Rsearch LLC
-
-
South Carolina
-
Mount Pleasant, South Carolina, United States, 29464
- Coastal Carolina Research Center - Mount Pleasant
-
-
Tennessee
-
Chattanooga, Tennessee, United States, 37421
- WR-ClinSearch LLC
-
Chattanooga, Tennessee, United States, 37404
- Chattanooga Medical Research LLC
-
Kingsport, Tennessee, United States, 37660
- Holston Medical Group - Kingsport
-
-
Texas
-
Fort Worth, Texas, United States, 76104
- Ventavia Research Group, LLC
-
Houston, Texas, United States, 77081
- Texas Center for Drug Development Inc
-
Keller, Texas, United States, 76248
- Ventavia Research Group, LLC
-
-
Utah
-
Salt Lake City, Utah, United States, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
-
-
Washington
-
Bellevue, Washington, United States, 98007
- Northwest Clinical Research Center
-
-
Wisconsin
-
Neenah, Wisconsin, United States, 54956
- Neuroscience Group
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Eptinezumab
Participants will receive a single dose of eptinezumab 100 milligrams (mg) administered via intravenous (IV) infusion on Day 0.
|
Injection for IV administration
|
Placebo Comparator: Placebo
Participants will receive a single dose of placebo matching to eptinezumab administered via IV infusion on Day 0.
|
Injection for IV administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Headache Pain Freedom
Time Frame: 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.
|
Up to 48 hours postdose
|
Time to Absence of Most Bothersome Symptom (MBS)
Time Frame: 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).
|
Up to 48 hours postdose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Headache Pain Freedom at 2 Hours
Time Frame: 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
|
Absence of MBS at 2 Hours
Time Frame: 2 hours
|
Number of participants with absence of MBS (of nausea, photophobia, or phonophobia) at 2 hours postdose are reported.
|
2 hours
|
Headache Pain Freedom at 4 Hours
Time Frame: 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
|
Absence of MBS at 4 Hours
Time Frame: 4 hours
|
Number of participants with absence of MBS (of nausea, photophobia, or phonophobia) at 4 hours postdose are reported.
|
4 hours
|
Use of Rescue Medication Within the First 24 Hours
Time Frame: 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.
|
Up to 24 hours postdose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 7, 2019
Primary Completion (Actual)
July 8, 2020
Study Completion (Actual)
July 8, 2020
Study Registration Dates
First Submitted
November 2, 2019
First Submitted That Met QC Criteria
November 2, 2019
First Posted (Actual)
November 5, 2019
Study Record Updates
Last Update Posted (Actual)
August 17, 2021
Last Update Submitted That Met QC Criteria
August 13, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALD403-CLIN-015
- 18903A (Other Identifier: H. Lundbeck A/S)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Migraine
-
Austrian Migraine Registry CollaborationMedical University of Vienna; Medical University Innsbruck; Austrian Headache...RecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineAustria
-
Tonix Pharmaceuticals, Inc.PremierCompletedChronic Migraine | Chronic Migraine, Headache | Chronic Migraine Without Aura | Aura MigraineUnited States
-
Harvard University Faculty of MedicineBrigham and Women's Hospital; Palmer Center for Chiropractic Research (PCCR)CompletedMigraine | Migraine Disorders | Migraine Without Aura | Migraine With Aura | Migraine, ClassicUnited States
-
University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
-
Notre-Dame Hospital, Montreal, Quebec, CanadaAllerganCompletedChronic Migraine | Migraine Without Aura | Migraine With AuraCanada
-
Glostrup University Hospital, CopenhagenUnknownChronic Migraine | Migraine Without Aura | Migraine With AuraDenmark
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...CompletedMigraine With Aura | Migraine in ChildrenItaly
-
University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
-
CoolTech LLCTerminatedMigraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineUnited States
-
The Cleveland ClinicWithdrawnMigraine | Migraine Disorders | Headache Disorders, Primary | Migraine Headache | Migraine Without Aura | Migraine With Aura | Headache, MigraineUnited States
Clinical Trials on Eptinezumab
-
Alder Biopharmaceuticals, Inc.CompletedMigraine DisorderUnited States
-
H. Lundbeck A/SCompletedMigraine | Migraine in ChildrenUnited States
-
H. Lundbeck A/SCompleted
-
Alder Biopharmaceuticals, Inc.CompletedMigraine DisordersUnited States, Belgium, Italy, Spain, United Kingdom, Germany, Hungary, Georgia, Slovakia, Russian Federation, Ukraine, Denmark, Czechia
-
H. Lundbeck A/SCompletedChronic Cluster HeadacheSpain, Germany, United Kingdom, United States, Netherlands, Denmark, Finland, France, Italy
-
H. Lundbeck A/SCompletedA Study in Healthy Adults Investigating Eptinezumab Produced by 2 Different Manufacturing Cell LinesHealthy ParticipantsUnited States
-
H. Lundbeck A/SRecruitingChronic Migraine in ChildrenSpain, United States, Portugal, Italy, Serbia, Argentina, Mexico, Canada, United Kingdom, Turkey
-
Alder Biopharmaceuticals, Inc.CompletedMigraine DisordersUnited States, Georgia, Australia, New Zealand
-
Alder Biopharmaceuticals, Inc.CompletedMigraine DisordersUnited States, Georgia