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| Name | Class |
|---|---|
| Registrat-Mapi | OTHER |
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This is a prospective, observational trial evaluating the "real world" use of Xeomin®(incobotulinumtoxinA). Physicians may enroll patients who are eligible to be treated with a botulinum toxin for cervical dystonia or blepharospasm based upon their clinical experience. The physician must have chosen to treat the patient with Xeomin® (incobotulinumtoxinA) prior to and independent of enrollment in this study. Physicians may choose to treat their subjects with up to 2 treatment cycles (approximately 6 months/subject) of Xeomin® (incobotulinumtoxinA) at a dose determined by the physician based upon his/her clinical experience with botulinum toxin. According and dependent on clinical practice, the investigators expect that subjects will be seen by the investigator for an average of 3 visits (two treatment cycles).
The primary objective of this trial is to collect, evaluate, and report observational data about the clinical use of Xeomin® in a "real world" setting to determine which muscles are injected, the dose used, and how doctors administer the injection.
The secondary objectives of this trial are: To collect and evaluate information about the efficacy of Xeomin®. To collect and evaluate information about the effect of Xeomin® on work productivity and quality of life. To monitor for any serious side effects and non-serious related side effects of Xeomin®
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical Dystonia | The target populations for which the sample size calculations are based are adult subjects aged ≥ 18 years with clinical diagnoses of cervical dystonia. |
| |
| Blepharospasm | The target populations for which the sample size calculations are based are adult subjects aged ≥ 18 years with clinical diagnoses of blepharospasm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xeomin® | Biological | Xeomin® (incobotulinumtoxinA) at a dose determined by the physician based upon his/her clinical experience with botulinum toxin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of injection patterns and techniques | To collect, evaluate and report observational data about the clinical use of Xeomin® in a "real world" setting to determine injection patterns and use of guidance techniques. | Two treatment cycles (approximately 6 months/subject) |
| Measure | Description | Time Frame |
|---|---|---|
| To collect and evaluate efficacy of Xeomin®(incobotulinumtoxinA) including onset and offset of effect as well as improvement of disease specific and global illness severity | Two treatment cycles (approximately 6 months/subject) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects 18 years of age or older. The physician must have chosen to treat the patient with Xeomin® (incobotulinumtoxinA) prior to and independent of enrollment in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Hubert H. Fernandez, MD, FAAN | Center for Neurological Restoration | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site #001052 | Cullman | Alabama | 35058 | United States | ||
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|
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Site # 001974 | Tucson | Arizona | 85713 | United States |
| Site #001046 | Encinitas | California | 92024 | United States |
| Site # 001822 | Fountain Valley | California | 92708 | United States |
| Site # 001852 | La Jolla | California | 92037 | United States |
| Merz Investigative Site #001986 | Los Angeles | California | 90095 | United States |
| Site # 001924 | Los Gatos | California | 95032 | United States |
| Site # 001005 | Newport Beach | California | 92663 | United States |
| Site # 001973 | Sacramento | California | 95817 | United States |
| Site # 001977 | New Haven | Connecticut | 06520 | United States |
| Site # 001901 | Washington D.C. | District of Columbia | 20007 | United States |
| Site # 001803 | Boca Raton | Florida | 33486 | United States |
| Site # 001805 | North Palm Beach | Florida | 33408 | United States |
| Site # 001955 | Sarasota | Florida | 34239 | United States |
| Site # 001823 | St. Petersburg | Florida | 33713 | United States |
| Site # 001972 | Chicago | Illinois | 60611 | United States |
| Site #001057 | Glenview | Illinois | 60026 | United States |
| Site #001978 | Lake Bluff | Illinois | 60044 | United States |
| Site # 001820 | Winfield | Illinois | 60190 | United States |
| Site # 001995 | Munster | Indiana | 46321 | United States |
| Site # 001833 | Overland Park | Kansas | 66211 | United States |
| Site # 001047 | Baton Rouge | Louisiana | 70810 | United States |
| Site # 001849 | Baltimore | Maryland | 21287 | United States |
| Site # 001053 | Boston | Massachusetts | 02114 | United States |
| Site # 001816 | Roseville | Michigan | 48066 | United States |
| Site # 001848 | Warren | Michigan | 48088 | United States |
| Site # 001028 | Bloomington | Minnesota | 55431 | United States |
| Site # 001834 | Eagan | Minnesota | 55122 | United States |
| Site # 001957 | Minneapolis | Minnesota | 55455 | United States |
| Site # 001802 | Des Peres | Missouri | 63131 | United States |
| Site # 001838 | St Louis | Missouri | 63141 | United States |
| Site # 001010 | Las Vegas | Nevada | 89102 | United States |
| Site # 001954 | Reno | Nevada | 89509 | United States |
| Site #001961 | Toms River | New Jersey | 08755 | United States |
| Site # 001860 | Kingston | New York | 12401 | United States |
| Site # 001041 | New York | New York | 10003 | United States |
| Site # 001921 | New York | New York | 10011 | United States |
| Site # 001910 | New York | New York | 10029 | United States |
| Site # 001034 | North Syracuse | New York | 13212 | United States |
| Site # 001013 | Syracuse | New York | 13210 | United States |
| Site # 001951 | Durham | North Carolina | 27710 | United States |
| Merz Investigative Site # 001840 | Bellevue | Ohio | 44811 | United States |
| Site # 001812 | Cleveland | Ohio | 44195 | United States |
| Site # 001826 | Columbus | Ohio | 43215 | United States |
| Site # 001815 | Tulsa | Oklahoma | 74136 | United States |
| Site # 001916 | Bend | Oregon | 97701 | United States |
| Site # 001839 | Medford | Oregon | 97504 | United States |
| Site #001000 | Collegeville | Pennsylvania | 19426 | United States |
| Site # 001959 | Philadelphia | Pennsylvania | 19107 | United States |
| Site #001032 | Wynnewood | Pennsylvania | 19096 | United States |
| Site # 001893 | Spartanburg | South Carolina | 29303 | United States |
| Site # 001922 | Chattanooga | Tennessee | 37411 | United States |
| Site # 001889 | Columbia | Tennessee | 38401 | United States |
| Site # 001831 | Memphis | Tennessee | 38163 | United States |
| Site # 001836 | Nashville | Tennessee | 37203 | United States |
| Merz Investigative Site # 001055 | Bedford | Texas | 76021 | United States |
| Site # 001055 | Bedford | Texas | 76021 | United States |
| Site # 001037 | Bedford | Texas | 76022 | United States |
| Site # 001817 | Dallas | Texas | 75214 | United States |
| Site # 001809 | Dallas | Texas | 75231 | United States |
| Site # 001022 | Houston | Texas | 77030 | United States |
| Site # 001813 | Houston | Texas | 77030 | United States |
| Site #001802 | Houston | Texas | 77030 | United States |
| Site # 001960 | Tyler | Texas | 75701 | United States |
| Site # 001962 | Alexandria | Virginia | 22311 | United States |
| Site # 001980 | Fishersville | Virginia | 22939 | United States |
| Site #001979 | Virginia Beach | Virginia | 23454 | United States |
| Site # 001881 | Kirkland | Washington | 98034 | United States |
| Site # 001800 | Spokane | Washington | 99204 | United States |
| ID | Term |
|---|---|
| D014103 | Torticollis |
| D001764 | Blepharospasm |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
| D001905 | Botulinum Toxins |
| ID | Term |
|---|---|
| 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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