NCT04418765

A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With an Extension Period to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 892 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of eptinezumab in the prevention of migraine in participants with unsuccessful prior preventive treatments.

Detailed description

The total study duration from the screening visit to the completion visit is approximately 76 weeks and includes a screening period (28-30 days), a placebo-controlled treatment period (24 weeks) and a treatment extension period (48 weeks). The participant will start treatment at the baseline visit and follow a 12-week dosing schedule with either eptinezumab (100 or 300 milligrams \[mg\]) or placebo by intraveneous (IV) infusion. Participants who were assigned to placebo in the placebo-controlled treatment period, will be randomly allocated to one of two treatment groups: eptinezumab 300 mg or eptinezumab 100 mg.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Eptinezumab	Eptinezumab, concentrate for solution for infusion 100 mg/milliliter (mL)
DRUG	Placebo	concentrate for solution for infusion, intravenously

Timeline

• Start date: 2020-06-01
• Primary completion: 2021-07-15
• Completion: 2022-09-15
• First posted: 2020-06-05
• Last updated: 2023-09-29
• Results posted: 2022-07-22

Locations

138 sites across 17 countries: United States, Belgium, Bulgaria, Czechia, Denmark, Finland, France, Georgia, Germany, Hungary, Italy, Poland, Russia, Slovakia, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study