Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine (Sunrise)
Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine (Sunrise)
Brief Summary:
This study evaluates the efficacy of eptinezumab to prevent migraine in participants with chronic migraine.
Detailed Description:
This is an interventional, multi-regional, multi-site, randomized, double-blind, placebo-controlled Phase III study, to confirm the efficacy and safety of eptinezumab in participants with chronic migraine who are eligible for preventive treatment.
Participants will be randomly allocated to one of three treatment groups: eptinezumab 300 mg, eptinezumab 100 mg, or placebo.
The double-blind, placebo-controlled treatment period will be followed by an extension period where all participants will receive active treatment to further assess the safety and tolerability of eptinezumab.
The total study duration from the Screening Visit to the Safety Follow-up Visit is approximately 36 weeks and includes a Screening Period (28-30 days), a Placebo-controlled Period (12 weeks), an Extension Period (12 weeks), and a Safety Follow-up Period (8 weeks).
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 945 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate Efficacy and Safety of Eptinezumab for the Preventive Treatment of Migraine
Actual Study Start Date: May 29, 2021
Estimated Primary Completion Date: October 22, 2024
Estimated Study Completion Date: March 11, 2025
Arms:
- Experimental: Eptinezumab 300 mg
- Experimental: Eptinezumab 100 mg
- Placebo Comparator: Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 945 |
| Actual Study start date | 29 May 2021 |
| Estimated study completion date | 11 March 2025 |