NCT07018713 A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine
| NCT ID | NCT07018713 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Merz Therapeutics GmbH |
| Condition | Chronic Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 780 participants |
| Start Date | 2025-08-21 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 780 participants in total. It began in 2025-08-21 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this clinical trial, participants with chronic 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.
Eligibility Criteria
Inclusion Criteria: * Participant has a diagnosis of CM with or without aura according to the International Classification of Headache Disorders Edition 3 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 ≥ 15 headache days per month and history of ≥ 8 migraine days per month; and * During the last 28 days of the screening period, participant experiencing: ≥ 15 headache days and ≥ 8 migraine days that qualify as such per the headache diary. Exclusion Criteria: * 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.
Contact & Investigator
Merz Medical Expert
STUDY DIRECTOR
Merz Therapeutics
Frequently Asked Questions
Who can join the NCT07018713 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07018713 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 780 participants.
Is NCT07018713 currently recruiting?
Yes, NCT07018713 is actively recruiting participants. Contact the research team at clinicaltrials@merz.com for enrollment information.
Where is the NCT07018713 trial being conducted?
This trial is being conducted at Chandler, United States, Phoenix, United States, Little Rock, United States, Lancaster, United States and 11 additional locations.
Who is sponsoring the NCT07018713 clinical trial?
NCT07018713 is sponsored by Merz Therapeutics GmbH. The principal investigator is Merz Medical Expert at Merz Therapeutics. The trial plans to enroll 780 participants.
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