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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515715-22-00 | EU Trial (CTIS) Number |
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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;
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xeomin Dose A | Experimental | Placebo-controlled period + extension period: Xeomin injections at pericranial and cervical points (dose A) |
|
| Xeomin Dose B | Experimental | Placebo-controlled period + extension period: Xeomin injections at pericranial and cervical point (dose B) |
|
| Placebo | Placebo Comparator | Placebo-controlled period: Placebo injections at pericranial and cervical points. Extension period: Xeomin injections at pericranial and cervical points (dose A) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xeomin | Drug | Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A | Baseline to month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose B | Baseline to month 6 | |
| Change in monthly headache days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Contact | +49691503 | 3030 | clinicaltrials@merz.com |
| Name | Affiliation | Role |
|---|---|---|
| Merz Medical Expert | Merz Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TrialSphere Corp, Merz Investigational Site #0010513 | Recruiting | Chandler | Arizona | 85286 | United States | |
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|
| Placebo | Drug | Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl) |
|
| Baseline to month 6 |
| Change in monthly headache days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose B | Baseline to month 6 |
| Change in monthly acute migraine medication days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A | Baseline to month 6 |
| Change in monthly acute migraine medication days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose B | Baseline to month 6 |
| Change in frequency of migraine days from baseline (baseline monthly migraine days divided by 2) to two-week end-of-cycle periods (weeks 11 and 12 of Cycle 1 to 4) | Baseline up to 12 months |
| Percentage of participants who reported at least a 50% reduction in mean monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection | Baseline to month 6 |
| Incidence of treatment-emergent adverse events (TEAEs) related to treatment as assessed by the investigator in the placebo-controlled period | Month 6 |
| Arizona Neuroscience Research, Merz Investigational Site #0010521 |
| Recruiting |
| Phoenix |
| Arizona |
| 85018 |
| United States |
| Baptist Health Medical Center, Merz Investigational Site #0010520 | Recruiting | Little Rock | Arkansas | 72205 | United States |
| Chemidox Clinical Trials Inc, Merz Investigational Site #0010488 | Recruiting | Lancaster | California | 93534 | United States |
| Clinical Research Institute, Merz Investigational Site #0010487 | Recruiting | Los Angeles | California | 90048 | United States |
| Clinical Trials Management Services, Merz Investigational Site #0010526 | Recruiting | Thousand Oaks | California | 91360 | United States |
| BNL Health Inc., Merz Investigational Site #0010489 | Recruiting | Torrance | California | 90505 | United States |
| Hasbani Neurology, Merz Investigational Site #0010509 | Recruiting | New Haven | Connecticut | 06511 | United States |
| Yale Center for Clinical Investigations, Merz Investigational Site #0010527 | Recruiting | New Haven | Connecticut | 06519 | United States |
| New England Institute Neurology and Headache, Merz Investigational Site #0010441 | Recruiting | Stamford | Connecticut | 06905 | United States |
| Northwest Florida Clinical Research Group, Merz Investigational Site #0010286 | Recruiting | Gulf Breeze | Florida | 32561 | United States |
| Nexus Clinical Research Center, Merz Investigational Site #0010514 | Recruiting | Homestead | Florida | 33030 | United States |
| Jacksonville Center for Clinical Research, Merz Investigational Site #0010515 | Recruiting | Jacksonville | Florida | 32216 | United States |
| Clinical Research of Central Florida, Merz Investigational Site #0010532 | Recruiting | Lakeland | Florida | 33805 | United States |
| American Research Institute, Merz Investigational Site #0010492 | Recruiting | Miami | Florida | 33157 | United States |
| Premiere Research Institute at Palm Beach Neurology, Merz Investigational Site #0010499 | Recruiting | West Palm Beach | Florida | 33407 | United States |
| Accel Research - NeuroStudies, Merz Investigational Site #0010523 | Recruiting | Decatur | Georgia | 30030 | United States |
| Hawaii Pacific Neuroscience, Merz Investigational Site #0010510 | Recruiting | Honolulu | Hawaii | 96817 | United States |
| Kansas Institute of Research,, Merz Investigational Site #0010495 | Recruiting | Overland Park | Kansas | 66211 | United States |
| Crescent City Headache and Neurology Center, Merz Investigational Site #0010517 | Recruiting | Chalmette | Louisiana | 70043 | United States |
| DelRicht Clinical Research,, Merz Investigational Site #0010518 | Recruiting | New Orleans | Louisiana | 70115 | United States |
| Sinai Hospital of Baltimore, Merz Investigational Site #0010505 | Recruiting | Baltimore | Maryland | 21215 | United States |
| MedVadis Research, Merz Investigational Site #0010524 | Recruiting | Waltham | Massachusetts | 02451 | United States |
| Mass Institute of Clinical Research, Merz Investigational Site #0010506 | Recruiting | Westborough | Massachusetts | 01581 | United States |
| Vida Clinical Studies, Merz Investigational Site #0010498 | Recruiting | Dearborn Heights | Michigan | 48127 | United States |
| Quest Research Institute, Merz Investigational Site #0010484 | Recruiting | Farmington Hills | Michigan | 48334 | United States |
| StudyMetrix Research, Merz Investigational Site #0010530 | Recruiting | City of Saint Peters | Missouri | 63303 | United States |
| Quality Clinical Research, Merz Investigational Site #0010522 | Recruiting | Omaha | Nebraska | 68114 | United States |
| Dent Neurosciences Research Center, Merz Investigational Site #0010486 | Recruiting | Amherst | New York | 14226 | United States |
| Integrative Clinical Trials, Merz Investigational Site #0010496 | Recruiting | Brooklyn | New York | 11229 | United States |
| New York Neurology Associates, Merz Investigational Site #0010500 | Recruiting | New York | New York | 10003 | United States |
| True North Neurology, Merz Investigational Site #0010508 | Recruiting | Port Jefferson Station | New York | 11776 | United States |
| Rochester Clinical Research, Merz Investigational Site #0010512 | Recruiting | Rochester | New York | 14609 | United States |
| Upstate Clinical Research Associates, Merz Investigational Site #0010485 | Recruiting | Williamsville | New York | 14221 | United States |
| Dayton Center for Neurological Disorders, Merz Investigational Site #0010531 | Recruiting | Centerville | Ohio | 45459 | United States |
| Headache Center of Hope, Merz Investigational Site #0010528 | Recruiting | Cincinnati | Ohio | 45236 | United States |
| University Hospitals Cleveland Medical Center, Merz Investigational Site #0010491 | Recruiting | Cleveland | Ohio | 44106 | United States |
| Tekton Research, Merz Investigational Site #0010494 | Recruiting | Edmond | Oklahoma | 73013 | United States |
| Thomas Jefferson University, Merz Investigational Site #0010354 | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Coastal Neurology, Merz Investigational Site #0010503 | Recruiting | Port Royal | South Carolina | 29935 | United States |
| Alina Clinical Trials, Merz Investigational Site #0010511 | Recruiting | Dallas | Texas | 75209 | United States |
| Lone Star Neurology, Merz Investigational Site #0010497 | Recruiting | Frisco | Texas | 75035 | United States |
| MedStar Health - Department of Neurology, Merz Investigational Site #0010231 | Recruiting | McLean | Virginia | 22101 | United States |
| Gershon Pain Specialists, Merz Investigational Site #0010519 | Recruiting | Virginia Beach | Virginia | 23454 | United States |
| EvergreenHealth Research Department, Merz Investigational Site #0010516 | Recruiting | Kirkland | Washington | 98034 | United States |
| Gundersen Health System, Merz Investigational Site #0010507 | Recruiting | La Crosse | Wisconsin | 54601 | United States |
| Medical University of Innsbruck, Merz Investigational Site #0430043 | Recruiting | Innsbruck | 6020 | Austria |
| Klinikum Klagenfurt Am Wörthersee, Merz Investigational Site #0430042 | Recruiting | Klagenfurt | 9020 | Austria |
| Genge Partners Inc., Merz Investigational Site #0010525 | Recruiting | Montreal | H4A 3T2 | Canada |
| CaRe Clinic, Merz Investigational Site #0010504 | Recruiting | Red Deer | T4P 1K4 | Canada |
| Pratia Brno, Merz Investigational Site #4200053 | Recruiting | Brno | 602 00 | Czechia |
| Fakultní nemocnice Hradec Králové, Merz Investigational Site #4200056 | Recruiting | Hradec Králové | 500 05 | Czechia |
| CLINTRIAL, Merz Investigational Site #4200052 | Recruiting | Prague | 100 00 | Czechia |
| Axon Clinical, Merz Investigational Site #4200051 | Recruiting | Prague | 150 00 | Czechia |
| Neuropsychiatrie, Merz Investigational Site #4200054 | Recruiting | Prague | 160 00 | Czechia |
| Rigshospitalet-Glostrup, Merz Investigational Site #0450006 | Recruiting | Glostrup Municipality | 2600 | Denmark |
| CHU Clermont Ferrand, Merz Investigational Site #0330026 | Recruiting | Clermont-Ferrand | 63000 | France |
| Centre Hospitalier Universitaire Grenoble Alpes, Merz Investigational Site #0330069 | Recruiting | La Tronche | 38700 | France |
| CHU Nantes, Merz Investigational Site #0330068 | Recruiting | Nantes | 44093 | France |
| Charité - Universitätsmedizin Berlin, Merz Investigational Site #0490398 | Recruiting | Berlin | 10117 | Germany |
| Kopfschmerzzentrum Frankfurt, Merz Investigational Site #0490394 | Recruiting | Frankfurt | 65929 | Germany |
| Universitätsmedizin Greifswald, Merz Investigational Site #0490397 | Recruiting | Greifswald | 17475 | Germany |
| Vitos Orthopädische Klinik Kassel, Merz Investigational Site #0490396 | Recruiting | Kassel | 34131 | Germany |
| Schmerzklinik Kiel GmbH, Merz Investigational Site #0490395 | Recruiting | Kiel | 24149 | Germany |
| Azienda Ospedaliera Universitaria Careggi, Merz Investigational Site #0390023 | Recruiting | Florence | 50134 | Italy |
| Ospedale San Raffaele, Merz Investigational Site #0390027 | Recruiting | Milan | 20132 | Italy |
| Istituto Auxologico Italiano, Merz Investigational Site #0390024 | Recruiting | Milan | 20149 | Italy |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino, Merz Investigational Site #0390025 | Recruiting | Pavia | 27100 | Italy |
| IRCCS San Raffaele Roma, Merz Investigational Site #0390026 | Recruiting | Roma | 00166 | Italy |
| Centrum Medyczne Neuromed, Merz Investigational Site #0480117 | Recruiting | Bydgoszcz | 85-163 | Poland |
| AthleticoMed, Merz Investigational Site #0480127 | Recruiting | Bydgoszcz | 85-752 | Poland |
| ETG Debica, Merz Investigational Site #0480121 | Recruiting | Dębica | 39-200 | Poland |
| Centrum Medyczne Pratia Gdynia, Merz Investigational Site #0480126 | Recruiting | Gdynia | 81-338 | Poland |
| Silmedic Sp. z o.o., Merz Investigational Site #0480115 | Recruiting | Katowice | 40-282 | Poland |
| Jan Banach Research Spot, Merz Investigational Site #0480059 | Recruiting | Krakow | 30-539 | Poland |
| Pratia MCM, Merz Investigational Site #0480087 | Recruiting | Krakow | 30-727 | Poland |
| FutureMeds, Merz Investigational Site #0480125 | Recruiting | Krakow | 31-501 | Poland |
| Krakowska Akademia Neurologii, Merz Investigational Site #0480031 | Recruiting | Krakow | 31-505 | Poland |
| Neurocor, Merz Investigational Site #0480119 | Recruiting | Krakow | 31-870 | Poland |
| Clinirem, Merz Investigational Site #0480128 | Recruiting | Lublin | 20-064 | Poland |
| ETG Lublin, Merz Investigational Site #0480118 | Recruiting | Lublin | 20-412 | Poland |
| Indywidualna Praktyka Lekarska Dr hab. Med. Anna Szczepańska-Szerej, Merz Investigational Site #0480096 | Recruiting | Lublin | 20-582 | Poland |
| Instytut Zdrowia dr Boczarska-Jedynak, Merz Investigational Site #0480103 | Recruiting | Oświęcim | 32-600 | Poland |
| Solumed Centrum Medyczne, Merz Investigational Site #0480122 | Recruiting | Poznan | 60-529 | Poland |
| ETG Neuroscience, Merz Investigational Site #0480116 | Recruiting | Warsaw | 02-677 | Poland |
| MIGRE Polskie Centrum Leczenia Migreny, Merz Investigational Site #0480124 | Recruiting | Wroclaw | 52-210 | Poland |
| Futuremeds, Merz Investigational Site #0480123 | Recruiting | Wroclaw | 53-673 | Poland |
| ETG Zamosc, Merz Investigational Site #0480120 | Recruiting | Zamość | 22-400 | Poland |
| MUDr. Beáta Dupejová, neurologická ambulancia, Merz Investigational Site #4210002 | Recruiting | Banská Bystrica | 974 04 | Slovakia |
| KONZÍLIUM, Merz Investigational Site #4210011 | Recruiting | Dubnica nad Váhom | 018 41 | Slovakia |
| NEURES, Merz Investigational Site #4210006 | Recruiting | Krompachy | 053 42 | Slovakia |
| Liptovská nemocnica s poliklinikou, Merz Investigational Site #4210013 | Recruiting | Liptovský Mikuláš | 031 23 | Slovakia |
| Hospital Clinic de Barcelona-Hospital Plato, Merz Investigational Site #0340047 | Recruiting | Barcelona | 08006 | Spain |
| Hospital Universitari Vall d'Hebron, Merz Investigational Site #0340006 | Recruiting | Barcelona | 08035 | Spain |
| Hospital Universitario 12 de Octubre, Merz Investigational Site #0340055 | Recruiting | Madrid | 28041 | Spain |
| Hospital Universitario La Paz, Merz Investigational Site #0340007 | Recruiting | Madrid | 28046 | Spain |
| Campus Blua Sanitas Valdebebas Hospital, Merz Investigational Site #0340057 | Recruiting | Madrid | 28055 | Spain |
| Hospital Regional Universitario de Malaga, Merz Investigational Site #0340050 | Recruiting | Málaga | 29010 | Spain |
| Hospital Universitario Virgen de la Victoria, Merz Investigational Site #0340056 | Recruiting | Málaga | 29010 | Spain |
| Hospital Vithas Malaga, Merz Investigational Site #0340054 | Recruiting | Málaga | 29016 | Spain |
| Hospital Universitario Virgen del Rocio, Merz Investigational Site #0340046 | Recruiting | Seville | 41013 | Spain |
| Consorci Sanitari de Terrassa, Merz Investigational Site #0340051 | Recruiting | Terrassa | 08227 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia, Merz Investigational Site #0340049 | Recruiting | Valencia | 46026 | Spain |
| Complejo Hospitalario Universitario de Vigo, Merz Investigational Site #0340052 | Recruiting | Vigo | 36312 | Spain |
| Hospital Viamed Montecanal, Merz Investigational Site #0340053 | Recruiting | Zaragoza | 50012 | Spain |
| Inselspital Bern, Merz Investigational Site #0410003 | Recruiting | Bern | 3010 | Switzerland |
| Kopfwehzentrum Hirslanden, Merz Investigational Site #0410017 | Recruiting | Zollikon | 8702 | Switzerland |
| Royal Stoke University Hospital, Merz Investigational Site #0440048 | Recruiting | Stoke-on-Trent | ST4 6QG | United Kingdom |
| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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