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A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Clinical Trial With Extension Period to Evaluate the Efficacy and Safety of Xeomin® Injections for the Prevention of Episodic Migraine

Status: Recruiting
Location: See all (100) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arkansas
Baptist Health Medical Center, Merz Investigational Site #0010520
RECRUITING
Little Rock
Arizona
TrialSphere Corp, Merz Investigational Site #0010513
RECRUITING
Chandler
Arizona Neuroscience Research, Merz Investigational Site #0010521
RECRUITING
Phoenix
California
Chemidox Clinical Trials Inc, Merz Investigational Site #0010488
RECRUITING
Lancaster
Clinical Research Institute, Merz Investigational Site #0010487
RECRUITING
Los Angeles
Clinical Trials Management Services, Merz Investigational Site #0010526
RECRUITING
Thousand Oaks
BNL Health Inc., Merz Investigational Site #0010489
RECRUITING
Torrance
Connecticut
Hasbani Neurology, Merz Investigational Site #0010509
RECRUITING
New Haven
Yale Center for Clinical Investigations, Merz Investigational Site #0010527
RECRUITING
New Haven
New England Institute Neurology and Headache, Merz Investigational Site #0010441
RECRUITING
Stamford
Florida
Northwest Florida Clinical Research Group, Merz Investigational Site #0010286
RECRUITING
Gulf Breeze
Nexus Clinical Research Center, Merz Investigational Site #0010514
RECRUITING
Homestead
Jacksonville Center for Clinical Research, Merz Investigational Site #0010515
RECRUITING
Jacksonville
Clinical Research of Central Florida, Merz Investigational Site #0010532
RECRUITING
Lakeland
American Research Institute, Merz Investigational Site #0010492
RECRUITING
Miami
Premiere Research Institute at Palm Beach Neurology, Merz Investigational Site #0010499
RECRUITING
West Palm Beach
Georgia
Accel Research - NeuroStudies, Merz Investigational Site #0010523
RECRUITING
Decatur
Hawaii
Hawaii Pacific Neuroscience, Merz Investigational Site #0010510
RECRUITING
Honolulu
Kansas
Kansas Institute of Research,, Merz Investigational Site #0010495
RECRUITING
Overland Park
Louisiana
Crescent City Headache and Neurology Center, Merz Investigational Site #0010517
RECRUITING
Chalmette
DelRicht Clinical Research,, Merz Investigational Site #0010518
RECRUITING
New Orleans
Massachusetts
MedVadis Research, Merz Investigational Site #0010524
RECRUITING
Waltham
Mass Institute of Clinical Research, Merz Investigational Site #0010506
RECRUITING
Westborough
Maryland
Sinai Hospital of Baltimore, Merz Investigational Site #0010505
RECRUITING
Baltimore
Michigan
Vida Clinical Studies, Merz Investigational Site #0010498
RECRUITING
Dearborn Heights
Quest Research Institute, Merz Investigational Site #0010484
RECRUITING
Farmington Hills
Missouri
StudyMetrix Research, Merz Investigational Site #0010530
RECRUITING
City Of Saint Peters
Nebraska
Quality Clinical Research, Merz Investigational Site #0010522
RECRUITING
Omaha
New York
Dent Neurosciences Research Center, Merz Investigational Site #0010486
RECRUITING
Amherst
Integrative Clinical Trials, Merz Investigational Site #0010496
RECRUITING
Brooklyn
New York Neurology Associates, Merz Investigational Site #0010500
RECRUITING
New York
True North Neurology, Merz Investigational Site #0010508
RECRUITING
Port Jefferson Station
Rochester Clinical Research, Merz Investigational Site #0010512
RECRUITING
Rochester
Upstate Clinical Research Associates, Merz Investigational Site #0010485
RECRUITING
Williamsville
Ohio
Dayton Center for Neurological Disorders, Merz Investigational Site #0010531
RECRUITING
Centerville
Headache Center of Hope, Merz Investigational Site #0010528
RECRUITING
Cincinnati
University Hospitals Cleveland Medical Center, Merz Investigational Site #0010491
RECRUITING
Cleveland
Oklahoma
Tekton Research, Merz Investigational Site #0010494
RECRUITING
Edmond
South Carolina
Coastal Neurology, Merz Investigational Site #0010503
RECRUITING
Port Royal
Texas
Alina Clinical Trials, Merz Investigational Site #0010511
RECRUITING
Dallas
Lone Star Neurology, Merz Investigational Site #0010497
RECRUITING
Frisco
Virginia
MedStar Health - Department of Neurology, Merz Investigational Site #0010231
RECRUITING
Mclean
Gershon Pain Specialists, Merz Investigational Site #0010519
RECRUITING
Virginia Beach
Wisconsin
Gundersen Health System, Merz Investigational Site #0010507
RECRUITING
La Crosse
Other Locations
Austria
Medical University of Innsbruck, Merz Investigational Site #0430043
RECRUITING
Innsbruck
Klinikum Klagenfurt Am Wörthersee, Merz Investigational Site #0430042
RECRUITING
Klagenfurt
Canada
Genge Partners Inc., Merz Investigational Site #0010525
RECRUITING
Montreal
CaRe Clinic, Merz Investigational Site #0010504
RECRUITING
Red Deer
Denmark
Rigshospitalet-Glostrup, Merz Investigational Site #0450006
RECRUITING
Glostrup Municipality
France
CHU Clermont Ferrand, Merz Investigational Site #0330026
RECRUITING
Clermont-ferrand
Centre Hospitalier Universitaire Grenoble Alpes, Merz Investigational Site #0330069
RECRUITING
La Tronche
CHU Nantes, Merz Investigational Site #0330068
RECRUITING
Nantes
Germany
Charité - Universitätsmedizin Berlin, Merz Investigational Site #0490398
RECRUITING
Berlin
Kopfschmerzzentrum Frankfurt, Merz Investigational Site #0490394
RECRUITING
Frankfurt
Universitätsmedizin Greifswald, Merz Investigational Site #0490397
RECRUITING
Greifswald
Vitos Orthopädische Klinik Kassel, Merz Investigational Site #0490396
RECRUITING
Kassel
Schmerzklinik Kiel GmbH, Merz Investigational Site #0490395
RECRUITING
Kiel
Italy
Azienda Ospedaliera Universitaria Careggi, Merz Investigational Site #0390023
RECRUITING
Florence
Istituto Auxologico Italiano, Merz Investigational Site #0390024
RECRUITING
Milan
Ospedale San Raffaele, Merz Investigational Site #0390027
RECRUITING
Milan
Fondazione Istituto Neurologico Nazionale Casimiro Mondino, Merz Investigational Site #0390025
RECRUITING
Pavia
IRCCS San Raffaele Roma, Merz Investigational Site #0390026
RECRUITING
Roma
Poland
AthleticoMed, Merz Investigational Site #0480127
RECRUITING
Bydgoszcz
Centrum Medyczne Neuromed, Merz Investigational Site #0480117
RECRUITING
Bydgoszcz
ETG Debica, Merz Investigational Site #0480121
RECRUITING
Dębica
Centrum Medyczne Pratia Gdynia, Merz Investigational Site #0480126
RECRUITING
Gdynia
Silmedic Sp. z o.o., Merz Investigational Site #0480115
RECRUITING
Katowice
FutureMeds, Merz Investigational Site #0480125
RECRUITING
Krakow
Jan Banach Research Spot, Merz Investigational Site #0480059
RECRUITING
Krakow
Krakowska Akademia Neurologii, Merz Investigational Site #0480031
RECRUITING
Krakow
Neurocor, Merz Investigational Site #0480119
RECRUITING
Krakow
Pratia MCM, Merz Investigational Site #0480087
RECRUITING
Krakow
Clinirem, Merz Investigational Site #0480128
RECRUITING
Lublin
ETG Lublin, Merz Investigational Site #0480118
RECRUITING
Lublin
Indywidualna Praktyka Lekarska Dr hab. Med. Anna Szczepańska-Szerej, Merz Investigational Site #0480096
RECRUITING
Lublin
Instytut Zdrowia dr Boczarska-Jedynak, Merz Investigational Site #0480103
RECRUITING
Oświęcim
Solumed Centrum Medyczne, Merz Investigational Site #0480122
RECRUITING
Poznan
ETG Neuroscience, Merz Investigational Site #0480116
RECRUITING
Warsaw
Futuremeds, Merz Investigational Site #0480123
RECRUITING
Wroclaw
MIGRE Polskie Centrum Leczenia Migreny, Merz Investigational Site #0480124
RECRUITING
Wroclaw
ETG Zamosc, Merz Investigational Site #0480120
RECRUITING
Zamość
Slovakia
MUDr. Beáta Dupejová, neurologická ambulancia, Merz Investigational Site #4210002
RECRUITING
Banská Bystrica
KONZÍLIUM, Merz Investigational Site #4210011
RECRUITING
Dubnica Nad Váhom
NEURES, Merz Investigational Site #4210006
RECRUITING
Krompachy
Liptovská nemocnica s poliklinikou, Merz Investigational Site #4210013
RECRUITING
Liptovský Mikuláš
Spain
Hospital Clinic de Barcelona-Hospital Plato, Merz Investigational Site #0340047
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron, Merz Investigational Site #0340006
RECRUITING
Barcelona
Campus Blua Sanitas Valdebebas Hospital, Merz Investigational Site #0340057
RECRUITING
Madrid
Hospital Universitario 12 de Octubre, Merz Investigational Site #0340055
RECRUITING
Madrid
Hospital Universitario La Paz, Merz Investigational Site #0340007
RECRUITING
Madrid
Hospital Regional Universitario de Malaga, Merz Investigational Site #0340050
RECRUITING
Málaga
Hospital Universitario Virgen de la Victoria, Merz Investigational Site #0340056
RECRUITING
Málaga
Hospital Vithas Malaga, Merz Investigational Site #0340054
RECRUITING
Málaga
Hospital Universitario Virgen del Rocio, Merz Investigational Site #0340046
RECRUITING
Seville
Consorci Sanitari de Terrassa, Merz Investigational Site #0340051
RECRUITING
Terrassa
Hospital Universitari i Politecnic La Fe de Valencia, Merz Investigational Site #0340049
RECRUITING
Valencia
Complejo Hospitalario Universitario de Vigo, Merz Investigational Site #0340052
RECRUITING
Vigo
Hospital Viamed Montecanal, Merz Investigational Site #0340053
RECRUITING
Zaragoza
Switzerland
Kopfwehzentrum Hirslanden, Merz Investigational Site #0410017
RECRUITING
Zollikon
United Kingdom
Royal Stoke University Hospital, Merz Investigational Site #0440048
RECRUITING
Stoke-on-trent
Contact Information
Primary
Public Disclosure Manager
clinicaltrials@merz.com
+49691503
Time Frame
Start Date: 2025-08-21
Estimated Completion Date: 2027-10
Participants
Target number of participants: 990
Treatments
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)
Related Therapeutic Areas
Sponsors
Leads: Merz Therapeutics GmbH

This content was sourced from clinicaltrials.gov

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