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Looking for participantsPhase3

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine

Sponsor: Merz Therapeutics GmbH

NCT ID: NCT07018700

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
Mix of remote tasks and in-person visits
Drug or intervention
Xeomin (drug), Placebo (drug)
How long the study runs
Study runs about 26 months (dates as stated)
About the drug or intervention
Xeomin — drug: Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl) · Placebo — drug: Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
Patient visit burden
"Trial details include: * Trial duration: 52 to 55 weeks; * Screening period: 4 to 5 weeks; * Treatment duration: 4 treatments, each about 12 weeks apart; and * Visit frequency: about every 4 weeks, 14 visits in total." (as stated by sponsor)
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
990
Started
2025-08-21
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for episodic migraine
  • • Phase3 - 990 participants
  • • In this clinical trial, participants with episodic migraine will receive injections with Xeomin or Placebo into muscles of the head and neck

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with episodic migraine

Where?

  • • Stoke-on-Trent - Royal Stoke University Hospital, Merz Investigational Site #0440048

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

In this clinical trial, participants with episodic migraine will receive injections with Xeomin or Placebo into muscles of the head and neck. The purpose is to measure the change in monthly migraine days with Xeomin injections compared to Placebo injections. Trial details include: * Trial duration: 52 to 55 weeks; * Screening period: 4 to 5 weeks; * Treatment duration: 4 treatments, each about 12 weeks apart; and * Visit frequency: about every 4 weeks, 14 visits in total. The first and last visit and the 4 treatment visits are on-site, the other 8 visits are remote by phone / video call.

Episodic Migraine

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Participant age \< 50 years at the time of migraine onset;
  • ✓During the last 28 days of the screening period, participant experiencing: ≤ 14 headache days and 6 to 14 migraine...

Who cannot take part

  • ✗Diagnosis of chronic migraine;
  • ✗Diagnosis of other primary headache types, except tension-type headache, which is permitted;
  • ✗Diagnosis of secondary headache types, except medication overuse headache, which is permitted;
  • ✗Currently taking \> 1 prescribed drug for the preventive treatment of migraine;
  • ✗Discontinuation of anti-calcitonin gene-related peptide (CGRP) / anti-CGRP receptor monoclonal antibody treatment...
See the full criteria
Inclusion Criteria: * Participant has a diagnosis of EM with or without aura according to current International Classification of Headache Disorders (Edition 3 and Edition 4 alpha) criteria for ≥ 12 months and is able to distinguish migraine headaches from all other types of headaches; * Participant age \< 50 years at the time of migraine onset; * Participant meeting the following headache and migraine day criteria in each of the 3 months prior to screening: history of ≤ 14 headache days per month and history of 6 to 14 migraine days per month; and * During the last 28 days of the screening period, participant experiencing: ≤ 14 headache days and 6 to 14 migraine days that qualify as such per the headache diary. Exclusion Criteria: * Diagnosis of chronic migraine; * Diagnosis of other primary headache types, except tension-type headache, which is permitted; * Diagnosis of aura without headache, migraine with brainstem aura, hemicrania continua, hypnic headache, hemiplegic migraine, retinal migraine, persistent aura without infarction, migraine aura-triggered seizure, or previous migrainous infarction; * Diagnosis of secondary headache types, except medication overuse headache, which is permitted; * Currently taking \> 1 prescribed drug for the preventive treatment of migraine; * Discontinuation of anti-calcitonin gene-related peptide (CGRP) / anti-CGRP receptor monoclonal antibody treatment less than 5 months prior to screening.

Where Is This Study? (1 UK site)

Royal Stoke University Hospital, Merz Investigational Site #0440048

Stoke-on-Trent ST4 6QG, United Kingdom

Recruiting

How to Get in Touch

Public Disclosure Manager

Sponsor contact

CONTACT

+49691503 clinicaltrials@merz.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09