Trials / Recruiting
RecruitingNCT07018713
A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine
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 Chronic Migraine
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 780 (estimated)
- Sponsor
- Merz Therapeutics GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Xeomin | Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl) |
| DRUG | Placebo | Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl) |
Timeline
- Start date
- 2025-08-21
- Primary completion
- 2027-10-01
- Completion
- 2028-03-01
- First posted
- 2025-06-12
- Last updated
- 2026-04-08
Locations
104 sites across 13 countries: United States, Austria, Canada, Czechia, Denmark, France, Germany, Italy, Poland, Slovakia, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07018713. Inclusion in this directory is not an endorsement.