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

Study acronym: MINT-E
StatusActive, Not Recruiting
PhasePhase 3
Started

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Record History

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  1. Enrollment closed, study ongoing
    • Enrollment target: estimated 990 to confirmed 997
    • Study completion date: Oct 2027 to Sep 2027
    • Site details revised at 110 of 110 sites
  2. Eligibility criteria expanded, about 10 words
    • Site details revised at 1 of 110 sites
  3. Study sites: 109 to 110v22
  4. Study sites: 108 to 109v21
  5. Re-verified, no change to tracked fieldsv20
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  1. Study sites: 106 to 108v19
  2. Study sites: 104 to 106v18
  1. Trial sites expanded: 100 → 104 locationsv17
  2. Study sites: 96 to 100v16
  3. Study sites: 92 to 96v15
  4. Study sites: 87 to 92v14
  5. Study sites: 86 to 87v13
  6. Study sites: 74 to 86v12
  7. Study sites: 72 to 74v11
  8. Study sites: 68 to 72v10
  9. Study sites: 65 to 68v9
  10. Study sites: 56 to 65v8
  11. Study sites: 48 to 56v7
  12. Study sites: 28 to 48v6
  13. Study sites: 8 to 28v5
  14. Study sites: 2 to 8v4
  15. Study sites: 1 to 2
    • Start date changed from estimate of Aug 2025 to Aug 21, 2025
    v3
  16. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date: Oct 2025 to Aug 2025
    v2
  17. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07018700
Lead Sponsor Merz Therapeutics GmbH
Conditions
(from sponsor)		 Episodic Migraine
Enrollment 997 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov