MINT-E
Research type
Research Study
Full title
A Phase 3, randomized, double-blind, placebo-controlled, multicenter, clinical trial with extension period to evaluate the efficacy and safety of Xeomin® injections for the prevention of episodic migraine
IRAS ID
1012251
Contact name
Andreas Wagner
Contact email
Sponsor organisation
Merz Therapeutics GmbH
Eudract number
2024-515715-22
Clinicaltrials.gov Identifier
Research summary
The purpose of this clinical study is to measure how well the study drug Xeomin® (incobotulinumtoxinA) can help prevent episodic migraine. This will be tested by comparing it to a placebo which looks like the study drug but has no active substance.
Migraine is a common neurological disease. Typical signs of a migraine attack are moderate to severe pulsating headaches on one side of the head that last 4 to 72 hours. In episodic migraine, headaches occur on less than 15 days per month, and some of these headache days fulfil the migraine criteria.
The study has a screening period (4 to 5 weeks), a placebo-controlled period (24 weeks), and an extension period (24 weeks). Overall participation will be 52 to 55 weeks (around 12 months). At the start of the placebo-controlled period, eligible patients will be assigned to 1 of 3 groups: Xeomin Dose A, Xeomin Dose B, or placebo. The placebo-controlled period involves 2 treatment sessions. The study doctor will inject Xeomin Dose A, Xeomin Dose B, or placebo. In the extension period, all participants will receive Xeomin in 2 further treatment sessions. Participants who received Xeomin Dose A or Dose B in the placebo-controlled period will continue this treatment. Participants who received placebo will switch to Xeomin Dose A. Each treatment session contains injections into muscles of the head and neck.
Participants will visit the study site 6 times. Remote check-ups via telephone or video call will take place 4 and 8 weeks after each treatment session (8 altogether). The last visit will take place 48 weeks after first treatment. During the study, participants will regularly complete questionnaires on migraine/headache, health state, and changes since first treatment.
The study will take place in presumably 1 NHS site in the UK, and approximately 120 sites globally.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
25/SC/0275
Date of REC Opinion
17 Sep 2025
REC opinion
Further Information Favourable Opinion