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

Migraine Clinical Trial

— RELIEF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04152083
• Other study ID #: ALD403-CLIN-015
• Secondary ID: 18903A
• Status: Completed
• Phase: Phase 3
• Start date: November 7, 2019
• Est. completion date: July 8, 2020

Study information

• Verified date: August 2021
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 485
• Est. completion date: July 8, 2020
• Est. primary completion date: July 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Eptinezumab
Injection for IV administration
• Placebo
Injection for IV administration

Locations

Country	Name	City	State
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"	Tbilisi
United States	Albuqerque Clinical Trials	Albuquerque	New Mexico
United States	Dent Neurologic Institute - Amherst	Amherst	New York
United States	Advanced Research Center	Anaheim	California
United States	Michigan Head Pain and Neurological institute	Ann Arbor	Michigan
United States	Office of Doctor Frank Berenson	Atlanta	Georgia
United States	University of Colorado Hospital	Aurora	Colorado
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Alabama Clinical Therapeutics	Birmingham	Alabama
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Integrative Clinical Trials	Brooklyn	New York
United States	The Neurology Center of Southern California - Carlsbad	Carlsbad	California
United States	Chattanooga Medical research LLC	Chattanooga	Tennessee
United States	WR-ClinSearch LLC	Chattanooga	Tennessee
United States	Cedar Crosse Research Center	Chicago	Illinois
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	iResearch Atlanta, LLC	Decatur	Georgia
United States	Denver Neurological Clinic - Denver	Denver	Colorado
United States	Ventavia Research Group, LLC	Fort Worth	Texas
United States	Medicinae Doctor Clinical	Hallandale Beach	Florida
United States	AGA Clinical trials	Hialeah	Florida
United States	Texas Center for Drug Development Inc	Houston	Texas
United States	Ventavia Research Group, LLC	Keller	Texas
United States	Holston Medical Group - Kingsport	Kingsport	Tennessee
United States	Nevada Headache Institute	Las Vegas	Nevada
United States	Central Kentucky Research Associates	Lexington	Kentucky
United States	Baptist Health Center for Clinical Research	Little Rock	Arkansas
United States	Meridien Research - Maitland	Maitland	Florida
United States	Clinical Research Institute - Minneapolis	Minneapolis	Minnesota
United States	Coastal Carolina Research Center - Mount Pleasant	Mount Pleasant	South Carolina
United States	Neuroscience Group	Neenah	Wisconsin
United States	Coastal Connecticut Research LLC	New London	Connecticut
United States	Neuro-Behavioral Clinical Research Inc	North Canton	Ohio
United States	Excell research Inc	Oceanside	California
United States	College Park Family Care Center Physicians	Overland Park	Kansas
United States	Arizona Research Center	Phoenix	Arizona
United States	Summit Research Network	Portland	Oregon
United States	Phoenix Medical Research	Prairie Village	Kansas
United States	Anderson Clinical Research	Redlands	California
United States	Headache Neurology Research Institute	Ridgeland	Mississippi
United States	StudyMetrix Research	Saint Peters	Missouri
United States	J. Lewis Research, Inc. / Foothill Family Clinic	Salt Lake City	Utah
United States	Meridian Clinical Research - Savannah Neurology Specialists	Savannah	Georgia
United States	Frontier Clinical Rsearch LLC	Smithfield	Pennsylvania
United States	Clinvest Research	Springfield	Missouri
United States	Ki Health Partners LLC, dba New England Institute for Clinical Research	Stamford	Connecticut
United States	Delricht Research	Tulsa	Oklahoma
United States	MedVadis Research Corporation, LLC	Waltham	Massachusetts
United States	The George Washington Medical Faculty Associates	Washington	District of Columbia
United States	Palm Beach Neurology and Premiere Research Institute	West Palm Beach	Florida
United States	Clinical Research of Central Florida	Winter Haven	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lundbeck A/S	Alder Biopharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	2 hours
Secondary	Absence of MBS at 2 Hours	Number of participants with absence of MBS (of nausea, photophobia, or phonophobia) at 2 hours postdose are reported.	2 hours
Secondary	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.	4 hours
Secondary	Absence of MBS at 4 Hours	Number of participants with absence of MBS (of nausea, photophobia, or phonophobia) at 4 hours postdose are reported.	4 hours
Secondary	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.	Up to 24 hours postdose