A Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Participants Experiencing Acute Attack of Migraine
(RELIEF Trial)
Recruiting in Palo Alto (17 mi)
+56 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: H. Lundbeck A/S
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
The purpose of this study is to evaluate the efficacy and safety of eptinezumab administered intravenously in participants experiencing an acute attack of migraine.
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.
Treatment Details
Interventions
- Eptinezumab (Monoclonal Antibodies)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EptinezumabExperimental Treatment1 Intervention
Participants will receive a single dose of eptinezumab 100 milligrams (mg) administered via intravenous (IV) infusion on Day 0.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive a single dose of placebo matching to eptinezumab administered via IV infusion on Day 0.
Eptinezumab is already approved in United States for the following indications:
🇺🇸 Approved in United States as Vyepti for:
- Preventive treatment of migraine in adults
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Colorado HospitalAurora, CO
StudyMetrix ResearchSaint Peters, MO
Boston Clinical TrialsBoston, MA
Michigan Head Pain and Neurological instituteAnn Arbor, MI
More Trial Locations
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Who Is Running the Clinical Trial?
H. Lundbeck A/SLead Sponsor
Alder Biopharmaceuticals, Inc.Industry Sponsor