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About
This study evaluates the efficacy of eptinezumab to prevent migraine in participants with chronic migraine.
Full 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).
Enrollment
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Inclusion criteria
Exclusion criteria
Other inclusion and exclusion criteria may apply
Primary purpose
Allocation
Interventional model
Masking
852 participants in 3 patient groups, including a placebo group
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Central trial contact
Email contact via H. Lundbeck A/S
Data sourced from clinicaltrials.gov
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