Eptinezumab for the prevention of migraine
Research type
Research Study
Full title
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
IRAS ID
1003196
Contact name
Peter Goadsby
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2019-004497-25
Research summary
Migraine is a disease that causes disabling headaches. There are several types of
preventive treatments that doctors prescribe in Europe and the US to their patients to
help them. Unfortunately, not all patients respond sufficiently well to these currently
available medications.
The purpose of this study is to determine if the research medication eptinezumab is safe
and effective as preventive treatment for those who have migraine and who have already
tried available migraine preventive treatments without being helped. Eptinezumab has
previously been tested in animals, healthy volunteers and adults with diagnosis of
migraine as a preventive treatment of migraine headaches.
Approximately up to 840 patients from Europe and the US will participate in this
research study and will be assigned to receive either:
Eptinezumab 300 mg, or
Eptinezumab 100 mg, or
Placebo
In the initial part of the study (placebo-controlled period), participants will have a 1 out
of 3 chance of being assigned to either one of these 3 groups (1:1:1 ratio). In the later
part of the study (extension period) all participants will receive treatment with
eptinezumab. Participants previously allocated to placebo will be randomly allocated to
receive 300mg or 100mg eptinezumab (1:1 ratio).
Participation in the study could last up to 76 weeks. Visits are completed approximately
every 4 weeks, either as clinic visits or as phone calls. Participants will receive an
intravenous infusion of their allocated study medication every 12 weeks at the site visits.
Eptinezumab or placebo will be administered via intravenous infusion.REC name
North West - Haydock Research Ethics Committee
REC reference
20/NW/0297
Date of REC Opinion
10 Aug 2020
REC opinion
Further Information Favourable Opinion