Trial Evaluating Xeomin® (incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States

Cervical Dystonia Clinical Trial

— XCiDaBLE  

Official title:

Prospective, Observational Trial Evaluating Xeomin®(incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01287247
• Other study ID #: MRZ 60201-4066-5
• Status: Completed
• Phase: N/A
• First received: January 28, 2011
• Last updated: April 9, 2015
• Start date: February 2011
• Est. completion date: April 2013

Study information

• Verified date: April 2015
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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).

Description:

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®

Recruitment information / eligibility

• Status: Completed
• Enrollment: 688
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

• Subjects who are eligible to be treated with a botulinum toxin for cervical dystonia or blepharospasm based upon the physicians' clinical experience. There are no restrictive subject entry criteria.

• Subjects who are able to read, speak and understand English.

Exclusion Criteria:

• Subjects who are enrolled in any clinical trial (currently or within the past 3 months) in which treatments are imposed by a protocol are not eligible for this trial.

• Any subject for whom botulinum toxin treatment would be contraindicated; see Xeomin® Prescribing Information for further details.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blepharospasm
• Cervical Dystonia
• Dystonia
• Dystonic Disorders
• Torticollis

Intervention

Biological:
• Xeomin®
Xeomin® (incobotulinumtoxinA) at a dose determined by the physician based upon his/her clinical experience with botulinum toxin.

Locations

Country	Name	City	State
United States	Site # 001962	Alexandria	Virginia
United States	Site # 001849	Baltimore	Maryland
United States	Site # 001047	Baton Rouge	Louisiana
United States	Merz Investigative Site # 001055	Bedford	Texas
United States	Site # 001037	Bedford	Texas
United States	Site # 001055	Bedford	Texas
United States	Merz Investigative Site # 001840	Bellevue	Ohio
United States	Site # 001916	Bend	Oregon
United States	Site # 001028	Bloomington	Minnesota
United States	Site # 001803	Boca Raton	Florida
United States	Site # 001053	Boston	Massachusetts
United States	Site # 001922	Chattanooga	Tennessee
United States	Site # 001972	Chicago	Illinois
United States	Site # 001812	Cleveland	Ohio
United States	Site #001000	Collegeville	Pennsylvania
United States	Site # 001889	Columbia	Tennessee
United States	Site # 001826	Columbus	Ohio
United States	Site #001052	Cullman	Alabama
United States	Site # 001809	Dallas	Texas
United States	Site # 001817	Dallas	Texas
United States	Site # 001802	Des Peres	Missouri
United States	Site # 001951	Durham	North Carolina
United States	Site # 001834	Eagan	Minnesota
United States	Site #001046	Encinitas	California
United States	Site # 001980	Fishersville	Virginia
United States	Site # 001822	Fountain Valley	California
United States	Site #001057	Glenview	Illinois
United States	Site # 001022	Houston	Texas
United States	Site # 001813	Houston	Texas
United States	Site #001802	Houston	Texas
United States	Site # 001860	Kingston	New York
United States	Site # 001881	Kirkland	Washington
United States	Site # 001852	La Jolla	California
United States	Site #001978	Lake Bluff	Illinois
United States	Site # 001010	Las Vegas	Nevada
United States	Merz Investigative Site #001986	Los Angeles	California
United States	Site # 001924	Los Gatos	California
United States	Site # 001839	Medford	Oregon
United States	Site # 001831	Memphis	Tennessee
United States	Site # 001957	Minneapolis	Minnesota
United States	Site # 001995	Munster	Indiana
United States	Site # 001836	Nashville	Tennessee
United States	Site # 001977	New Haven	Connecticut
United States	Site # 001041	New York	New York
United States	Site # 001910	New York	New York
United States	Site # 001921	New York	New York
United States	Site # 001005	Newport Beach	California
United States	Site # 001805	North Palm Beach	Florida
United States	Site # 001034	North Syracuse	New York
United States	Site # 001833	Overland Park	Kansas
United States	Site # 001959	Philadelphia	Pennsylvania
United States	Site # 001954	Reno	Nevada
United States	Site # 001816	Roseville	Michigan
United States	Site # 001973	Sacramento	California
United States	Site # 001823	Saint Petersburg	Florida
United States	Site # 001955	Sarasota	Florida
United States	Site # 001893	Spartanburg	South Carolina
United States	Site # 001800	Spokane	Washington
United States	Site # 001838	St. Louis	Missouri
United States	Site # 001013	Syracuse	New York
United States	Site #001961	Toms River	New Jersey
United States	Site # 001974	Tucson	Arizona
United States	Site # 001815	Tulsa	Oklahoma
United States	Site # 001960	Tyler	Texas
United States	Site #001979	Virginia Beach	Virginia
United States	Site # 001848	Warren	Michigan
United States	Site # 001901	Washington	District of Columbia
United States	Site # 001820	Winfield	Illinois
United States	Site #001032	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Merz Pharmaceuticals, LLC	Registrat-Mapi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	Yes