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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Xeomin Dose A 		Placebo-controlled period + extension period: Xeomin injections at pericranial and cervical points (dose A)
  • Drug: Xeomin
    Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
    Other names:
    • IncobotulinumtoxinA
    • NT 201
    • Botulinum toxin type A (150 kiloDalton), free from complexing proteins
Experimental
Xeomin Dose B 		Placebo-controlled period + extension period: Xeomin injections at pericranial and cervical point (dose B)
  • Drug: Xeomin
    Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
    Other names:
    • IncobotulinumtoxinA
    • NT 201
    • Botulinum toxin type A (150 kiloDalton), free from complexing proteins
Placebo Comparator
Placebo 		Placebo-controlled period: Placebo injections at pericranial and cervical points. Extension period: Xeomin injections at pericranial and cervical points (dose A)
  • Drug: Xeomin
    Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
    Other names:
    • IncobotulinumtoxinA
    • NT 201
    • Botulinum toxin type A (150 kiloDalton), free from complexing proteins
  • Drug: Placebo
    Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)

Recruiting Locations

MedStar Health - Department of Neurology, Merz Investigational Site #0010231
McLean, Virginia 22101

More Details

Status
Recruiting
Sponsor
Merz Therapeutics GmbH

Study Contact

Public Disclosure Manager
+49691503
clinicaltrials@merz.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.