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

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

  • Episodic Migraine

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

TrialSphere Corp, Merz Investigational Site #0010513
Chandler, Arizona 85286

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

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

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

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

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

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

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

Yale Center for Clinical Investigations, Merz Investigational Site #0010527
New Haven, Connecticut 06519

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

University Hospitals Cleveland Medical Center, Merz Investigational Site #0010491
Cleveland, Ohio 44106

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

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

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

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

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

Gershon Pain Specialists, Merz Investigational Site #0010519
Virginia Beach, Virginia 23454

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

More Details

Status
Recruiting
Sponsor
Merz Therapeutics GmbH

Study Contact

Public Disclosure Manager
+49691503
clinicaltrials@merz.com