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MigrainePhase 3RELIEFNCT04152083

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

A Phase 3 study testing Eptinezumab in people with Migraine, run by H. Lundbeck A/S at 57 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Migraine
What is being tested?
Eptinezumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
485 participants
Where
57 sitesin 2 countries
Study dates
7 Nov 2019to 8 Jul 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 18Show fewer
  • 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.

Trial locations and contacts

57 sites in 2 countries.

57 sites in 2 countries

United States52 sites

  • Albuqerque Clinical Trials

    Albuquerque, New Mexico, 87102

  • Dent Neurologic Institute - Amherst

    Amherst, New York, 14226

  • Advanced Research Center

    Anaheim, California, 92805

  • Michigan Head Pain and Neurological institute

    Ann Arbor, Michigan, 48104

  • Office of Doctor Frank Berenson

    Atlanta, Georgia, 30328

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Alabama Clinical Therapeutics

    Birmingham, Alabama, 35235

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Integrative Clinical Trials

    Brooklyn, New York, 11229

  • The Neurology Center of Southern California - Carlsbad

    Carlsbad, California, 92011

  • Chattanooga Medical research LLC

    Chattanooga, Tennessee, 37404

  • WR-ClinSearch LLC

    Chattanooga, Tennessee, 37421

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607

  • CTI Clinical Research center

    Cincinnati, Ohio, 45212

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303

  • Aventiv Research - Columbus

    Columbus, Ohio, 43213

  • Hometown Urgent Care And Research - Huber Heights

    Dayton, Ohio, 45424

  • iResearch Atlanta, LLC

    Decatur, Georgia, 30030

  • Denver Neurological Clinic - Denver

    Denver, Colorado, 80210

  • Ventavia Research Group, LLC

    Fort Worth, Texas, 76104

  • Medicinae Doctor Clinical

    Hallandale, Florida, 33009

  • AGA Clinical trials

    Hialeah, Florida, 33012

  • Texas Center for Drug Development Inc

    Houston, Texas, 77081

  • Ventavia Research Group, LLC

    Keller, Texas, 76248

  • Holston Medical Group - Kingsport

    Kingsport, Tennessee, 37660

  • Nevada Headache Institute

    Las Vegas, Nevada, 89113

  • Central Kentucky Research Associates

    Lexington, Kentucky, 40509

  • Baptist Health Center for Clinical Research

    Little Rock, Arkansas, 72205

  • Meridien Research - Maitland

    Maitland, Florida, 32751

  • Clinical Research Institute - Minneapolis

    Minneapolis, Minnesota, 55402

  • Coastal Carolina Research Center - Mount Pleasant

    Mt. Pleasant, South Carolina, 29464

  • Neuroscience Group

    Neenah, Wisconsin, 54956

  • Coastal Connecticut Research LLC

    New London, Connecticut, 06320

  • Neuro-Behavioral Clinical Research Inc

    North Canton, Ohio, 44720

  • Excell research Inc

    Oceanside, California, 92056

  • College Park Family Care Center Physicians

    Overland Park, Kansas, 66212

  • Arizona Research Center

    Phoenix, Arizona, 85053

  • Summit Research Network

    Portland, Oregon, 97210

  • Phoenix Medical Research

    Prairie Village, Kansas, 66208

  • Anderson Clinical Research

    Redlands, California, 92374

  • Headache Neurology Research Institute

    Ridgeland, Mississippi, 39157

  • J. Lewis Research, Inc. / Foothill Family Clinic

    Salt Lake City, Utah, 84109

  • Meridian Clinical Research - Savannah Neurology Specialists

    Savannah, Georgia, 31405

  • Frontier Clinical Rsearch LLC

    Smithfield, Pennsylvania, 15478

  • Clinvest Research

    Springfield, Missouri, 65810

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

    Stamford, Connecticut, 06905

  • Delricht Research

    Tulsa, Oklahoma, 74133

  • MedVadis Research Corporation, LLC

    Waltham, Massachusetts, 02451

  • The George Washington Medical Faculty Associates

    Washington D.C., District of Columbia, 20052

  • Palm Beach Neurology and Premiere Research Institute

    West Palm Beach, Florida, 33407

  • Clinical Research of Central Florida

    Winter Haven, Florida, 33880

Other trials in United States

Georgia5 sites

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

    Tbilisi

  • Ltd "Aversi Clinic"

    Tbilisi

  • Ltd "Multiprofile Clinica Consilium Medulla"

    Tbilisi

  • Ltd Simon Khechinashvili University Clinic

    Tbilisi

  • td "Israel-Georgia Medical Research Clinic Helsicore"

    Tbilisi

Other trials in Georgia

About this study

Official title: 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.

Read the 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
Being tested
Eptinezumab, Placebo
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EptinezumabDrug

    Injection for IV administration

  • PlaceboDrug

    Injection for IV administration

Study groups in NCT04152083
Study groupRoleWhat they receive
EptinezumabExperimentalParticipants will receive a single dose of eptinezumab 100 milligrams (mg) administered via intravenous (IV) infusion on Day 0.
Receives: Drug: Eptinezumab
PlaceboPlacebo comparatorParticipants will receive a single dose of placebo matching to eptinezumab administered via IV infusion on Day 0.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 48 hours postdose

  2. 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).

    Measured: Up to 48 hours postdose

Secondary outcomes (5)

  1. 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.

    Measured: 2 hours

  2. Absence of MBS at 2 Hours

    Number of participants with absence of MBS (of nausea, photophobia, or phonophobia) at 2 hours postdose are reported.

    Measured: 2 hours

  3. 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.

    Measured: 4 hours

  4. Absence of MBS at 4 Hours

    Number of participants with absence of MBS (of nausea, photophobia, or phonophobia) at 4 hours postdose are reported.

    Measured: 4 hours

  5. 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.

    Measured: Up to 24 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2019
  2. Study start7 Nov 2019
  3. Primary completion8 Jul 2020
  4. Study completion8 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
485 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04152083
Sponsor's protocol ID
ALD403-CLIN-015
Other IDs
18903A
Acronym
RELIEF
Status last verified
Aug 2021
First submitted
2 Nov 2019
Last updated
17 Aug 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 35902796

  • 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.

    PubMed 35659622

  • 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.

    PubMed 35130832

  • 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.

    PubMed 34128999

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eptinezumab in people with Migraine, run by H. Lundbeck A/S at 57 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Headache Pain Freedom (time frame: Up to 48 hours postdose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04152083, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.

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