Clinical trial NCT04152083: A Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Participants Experiencing Acute Attack of Migraine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
Collaborators: name: Alder Biopharmaceuticals, Inc.
First posted: 2019-11-05
Enrollment: 485
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Time to Headache Pain Freedom
timeFrame: Up to 48 hours postdose
measure: Time to Absence of Most Bothersome Symptom (MBS)
timeFrame: Up to 48 hours postdose
Secondary outcomes:
measure: Headache Pain Freedom at 2 Hours
timeFrame: 2 hours
measure: Absence of MBS at 2 Hours
timeFrame: 2 hours
measure: Headache Pain Freedom at 4 Hours
timeFrame: 4 hours
measure: Absence of MBS at 4 Hours
timeFrame: 4 hours
measure: Use of Rescue Medication Within the First 24 Hours
timeFrame: Up to 24 hours postdose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Research Center
state: California
city: Carlsbad
country: United States
facility: The Neurology Center of Southern California - Carlsbad
state: California
city: Oceanside
country: United States
facility: Excell research Inc
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Denver
country: United States
facility: Denver Neurological Clinic - Denver
state: Colorado
city: New London
country: United States
facility: Coastal Connecticut Research LLC
state: Connecticut
city: Stamford
country: United States
facility: Ki Health Partners LLC, dba New England Institute for Clinical Research
state: Connecticut
city: Washington
country: United States
facility: The George Washington Medical Faculty Associates
state: District of Columbia
city: Hallandale Beach
country: United States
facility: Medicinae Doctor Clinical
state: Florida
city: Hialeah
country: United States
facility: AGA Clinical trials
state: Florida
city: Maitland
country: United States
facility: Meridien Research - Maitland
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Neurology and Premiere Research Institute
state: Florida
city: Winter Haven
country: United States
facility: Clinical Research of Central Florida
state: Florida
city: Atlanta
country: United States
facility: Office of Doctor Frank Berenson
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta, LLC
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research - Savannah Neurology Specialists
state: Georgia
city: Chicago
country: United States
facility: Cedar Crosse Research Center
state: Illinois
city: Overland Park
country: United States
facility: College Park Family Care Center Physicians
state: Kansas
city: Prairie Village
country: United States
facility: Phoenix Medical Research
state: Kansas
city: Lexington
country: United States
facility: Central Kentucky Research Associates
state: Kentucky
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Waltham
country: United States
facility: MedVadis Research Corporation, LLC
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head Pain and Neurological institute
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute - Minneapolis
state: Minnesota
city: Ridgeland
country: United States
facility: Headache Neurology Research Institute
state: Mississippi
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research
state: Missouri
city: Las Vegas
country: United States
facility: Nevada Headache Institute
state: Nevada
city: Albuquerque
country: United States
facility: Albuqerque Clinical Trials
state: New Mexico
city: Amherst
country: United States
facility: Dent Neurologic Institute - Amherst
state: New York
city: Brooklyn
country: United States
facility: Integrative Clinical Trials
state: New York
city: Cincinnati
country: United States
facility: CTI Clinical Research center
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research - Columbus
state: Ohio
city: Dayton
country: United States
facility: Hometown Urgent Care And Research - Huber Heights
state: Ohio
city: North Canton
country: United States
facility: Neuro-Behavioral Clinical Research Inc
state: Ohio
city: Tulsa
country: United States
facility: Delricht Research
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Smithfield
country: United States
facility: Frontier Clinical Rsearch LLC
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center - Mount Pleasant
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical research LLC
state: Tennessee
city: Chattanooga
country: United States
facility: WR-ClinSearch LLC
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group - Kingsport
state: Tennessee
city: Fort Worth
country: United States
facility: Ventavia Research Group, LLC
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development Inc
state: Texas
city: Keller
country: United States
facility: Ventavia Research Group, LLC
state: Texas
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Neenah
country: United States
facility: Neuroscience Group
state: Wisconsin
city: Tbilisi
country: Georgia
facility: Ltd "Acad Fridon Todua Medical Center - Ltd Research Institute of Clinical Medicine"
city: Tbilisi
country: Georgia
facility: Ltd "Aversi Clinic"
city: Tbilisi
country: Georgia
facility: Ltd "Multiprofile Clinica Consilium Medulla"
city: Tbilisi
country: Georgia
facility: Ltd Simon Khechinashvili University Clinic
city: Tbilisi
country: Georgia
facility: td "Israel-Georgia Medical Research Clinic Helsicore"
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.