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

Conditions

• Episodic Migraine

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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)

Study Details

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.

Key Dates

Start date

Aug 21, 2025

Status verified

May 2026

Primary completion

Mar 31, 2027

Completion

Oct 31, 2027

Study Design

Enrollment

990 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Xeomin Dose A
  Placebo-controlled period + extension period: Xeomin injections at pericranial and cervical points (dose A)
• Experimental: Xeomin Dose B
  Placebo-controlled period + extension period: Xeomin injections at pericranial and cervical point (dose B)
• Placebo Comparator: Placebo
  Placebo-controlled period: Placebo injections at pericranial and cervical points. Extension period: Xeomin injections at pericranial and cervical points (dose A)

Primary Outcome Measure

Change in monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A [ Time Frame: Baseline to month 6 ]

Central Contacts

• Public Disclosure Manager
  +49691503
  [email protected]

Locations (46)

Find similar trials in Chandler, AZ

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