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Purpose

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.

Condition

Eligibility

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

Inclusion Criteria

  • Participant has a diagnosis of EM with or without aura according to current International Classification of Headache Disorders (Edition 3 and Edition 4 alpha) 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 ≤ 14 headache days per month and history of 6 to 14 migraine days per month; and - During the last 28 days of the screening period, participant experiencing: ≤ 14 headache days and 6 to 14 migraine days that qualify as such per the headache diary.

Exclusion Criteria

  • Diagnosis of chronic migraine; - 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

Arizona Neuroscience Research, Merz Investigational Site #0010521
Phoenix 5308655, Arizona 5551752 85018

Baptist Health Medical Center, Merz Investigational Site #0010520
Little Rock 4119403, Arkansas 4099753 72205

Chemidox Clinical Trials Inc, Merz Investigational Site #0010488
Lancaster 5364940, California 5332921 93534

Clinical Research Institute, Merz Investigational Site #0010487
Los Angeles 5368361, California 5332921 90048

Clinical Trials Management Services, Merz Investigational Site #0010526
Thousand Oaks 5402405, California 5332921 91360

BNL Health Inc., Merz Investigational Site #0010489
Torrance 5403022, California 5332921 90505

Hasbani Neurology, Merz Investigational Site #0010509
New Haven 4839366, Connecticut 4831725 06511

New England Institute Neurology and Headache, Merz Investigational Site #0010441
Stamford 4843564, Connecticut 4831725 06905

Northwest Florida Clinical Research Group, Merz Investigational Site #0010286
Gulf Breeze 4157634, Florida 4155751 32561

Nexus Clinical Research Center, Merz Investigational Site #0010514
Homestead 4159050, Florida 4155751 33030

Jacksonville Center for Clinical Research, Merz Investigational Site #0010515
Jacksonville 4160021, Florida 4155751 32216

Clinical Research of Central Florida, Merz Investigational Site #0010532
Lakeland 4161438, Florida 4155751 33805

American Research Institute, Merz Investigational Site #0010492
Miami 4164138, Florida 4155751 33157

Premiere Research Institute at Palm Beach Neurology, Merz Investigational Site #0010499
West Palm Beach 4177887, Florida 4155751 33407

Accel Research - NeuroStudies, Merz Investigational Site #0010523
Decatur 4191124, Georgia 4197000 30030

Hawaii Pacific Neuroscience, Merz Investigational Site #0010510
Honolulu 5856195, Hawaii 5855797 96817

Kansas Institute of Research,, Merz Investigational Site #0010495
Overland Park 4276873, Kansas 4273857 66211

Crescent City Headache and Neurology Center, Merz Investigational Site #0010517
Chalmette 4319518, Louisiana 4331987 70043

DelRicht Clinical Research,, Merz Investigational Site #0010518
New Orleans 4335045, Louisiana 4331987 70115

Sinai Hospital of Baltimore, Merz Investigational Site #0010505
Baltimore 4347778, Maryland 4361885 21215

MedVadis Research, Merz Investigational Site #0010524
Waltham 4954380, Massachusetts 6254926 02451

Mass Institute of Clinical Research, Merz Investigational Site #0010506
Westborough 4955149, Massachusetts 6254926 01581

Vida Clinical Studies, Merz Investigational Site #0010498
Dearborn Heights 4990512, Michigan 5001836 48127

Quest Research Institute, Merz Investigational Site #0010484
Farmington Hills 4992523, Michigan 5001836 48334

StudyMetrix Research, Merz Investigational Site #0010530
City of Saint Peters 4407237, Missouri 4398678 63303

Quality Clinical Research, Merz Investigational Site #0010522
Omaha 5074472, Nebraska 5073708 68114

Dent Neurosciences Research Center, Merz Investigational Site #0010486
Amherst 5107129, New York 5128638 14226

Integrative Clinical Trials, Merz Investigational Site #0010496
Brooklyn 5110302, New York 5128638 11229

New York Neurology Associates, Merz Investigational Site #0010500
New York 5128581, New York 5128638 10003

True North Neurology, Merz Investigational Site #0010508
Port Jefferson Station 5132015, New York 5128638 11776

Rochester Clinical Research, Merz Investigational Site #0010512
Rochester 5134086, New York 5128638 14609

Upstate Clinical Research Associates, Merz Investigational Site #0010485
Williamsville 5144588, New York 5128638 14221

Dayton Center for Neurological Disorders, Merz Investigational Site #0010531
Centerville 4508204, Ohio 5165418 45459

Headache Center of Hope, Merz Investigational Site #0010528
Cincinnati 4508722, Ohio 5165418 45236

Tekton Research, Merz Investigational Site #0010494
Edmond 4535740, Oklahoma 4544379 73013

Coastal Neurology, Merz Investigational Site #0010503
Port Royal 4591896, South Carolina 4597040 29935

Alina Clinical Trials, Merz Investigational Site #0010511
Dallas 4684888, Texas 4736286 75209

Lone Star Neurology, Merz Investigational Site #0010497
Frisco 4692559, Texas 4736286 75035

Gundersen Health System, Merz Investigational Site #0010507
La Crosse 5258957, Wisconsin 5279468 54601

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.