Eptinezumab for Migraine

Recruiting in Palo Alto (17 mi)

+101 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: H. Lundbeck A/S

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?This trial is testing eptinezumab, a medication that prevents migraines, in adults who have migraines and medication overuse headaches. The goal is to see if it can reduce the number of days with migraines and headaches, and lower the use of other headache medications. The study lasts several months and includes different phases to monitor safety and effectiveness.

Eligibility Criteria

This trial is for adults under 50 with a migraine diagnosis who have had at least 8 migraine days and 15 headache days per month over the last three months. It's not suitable for those with certain pain syndromes, psychiatric conditions not well-controlled or treated in the past six months, unusual migraine subtypes, or significant cardiovascular issues.

Inclusion Criteria

I was diagnosed with migraines before or at the age of 50.

I have had 8 or more migraine days each month for the last 3 months.

I have been diagnosed with migraine or medication overuse headache.

+1 more

Exclusion Criteria

I have been diagnosed with a jaw joint disorder.

I have been diagnosed with a specific type of severe or unusual headache.

My psychiatric condition has been stable and treated for at least 6 months.

+2 more

Participant Groups

The study tests if Eptinezumab can reduce migraine frequency, headache days, and acute medication use in adults with migraines and MOH. Participants will either receive Eptinezumab or a placebo to compare outcomes between the two groups.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EptinezumabExperimental Treatment1 Intervention

Participants will receive an intravenous (IV) infusion of eptinezumab at Week 0 and Week 12.

Group II: PlaceboPlacebo Group2 Interventions

Participants will receive a single IV infusion of matching placebo to eptinezumab at Week 0. Then, all participants will receive a single IV infusion of eptinezumab at Week 12.

Eptinezumab is already approved in United States for the following indications:

🇺🇸 Approved in United States as Vyepti for: