Clinical trial NCT01287247: Trial Evaluating Xeomin® (incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States
Official title: Prospective, Observational Trial Evaluating Xeomin®(incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Dystonia
Blepharospasm
Keywords: Cervical dystonia
Blepharospasm
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Registrat-Mapi
First posted: 2011-02-01
Enrollment: 688
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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).

Detailed 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®

Eligibility criteria: 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.

Primary outcomes:
measure: Determination of injection patterns and techniques
timeFrame: Two treatment cycles (approximately 6 months/subject)
Secondary outcomes:
measure: 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
timeFrame: Two treatment cycles (approximately 6 months/subject)
Other outcomes:
Locations:
city: Cullman
country: United States
facility: Site #001052
state: Alabama
city: Scottsdale
country: United States
state: Arizona
city: Tucson
country: United States
facility: Site # 001974
state: Arizona
city: Encinitas
country: United States
facility: Site #001046
state: California
city: Fountain Valley
country: United States
facility: Site # 001822
state: California
city: La Jolla
country: United States
facility: Site # 001852
state: California
city: Los Angeles
country: United States
facility: Merz Investigative Site #001986
state: California
city: Los Gatos
country: United States
facility: Site # 001924
state: California
city: Newport Beach
country: United States
facility: Site # 001005
state: California
city: Sacramento
country: United States
facility: Site # 001973
state: California
city: New Haven
country: United States
facility: Site # 001977
state: Connecticut
city: Washington
country: United States
facility: Site # 001901
state: District of Columbia
city: Boca Raton
country: United States
facility: Site # 001803
state: Florida
city: North Palm Beach
country: United States
facility: Site # 001805
state: Florida
city: Saint Petersburg
country: United States
facility: Site # 001823
state: Florida
city: Sarasota
country: United States
facility: Site # 001955
state: Florida
city: Chicago
country: United States
facility: Site # 001972
state: Illinois
city: Glenview
country: United States
facility: Site #001057
state: Illinois
city: Lake Bluff
country: United States
facility: Site #001978
state: Illinois
city: Winfield
country: United States
facility: Site # 001820
state: Illinois
city: Munster
country: United States
facility: Site # 001995
state: Indiana
city: Overland Park
country: United States
facility: Site # 001833
state: Kansas
city: Baton Rouge
country: United States
facility: Site # 001047
state: Louisiana
city: Baltimore
country: United States
facility: Site # 001849
state: Maryland
city: Boston
country: United States
facility: Site # 001053
state: Massachusetts
city: Roseville
country: United States
facility: Site # 001816
state: Michigan
city: Warren
country: United States
facility: Site # 001848
state: Michigan
city: Bloomington
country: United States
facility: Site # 001028
state: Minnesota
city: Eagan
country: United States
facility: Site # 001834
state: Minnesota
city: Minneapolis
country: United States
facility: Site # 001957
state: Minnesota
city: Des Peres
country: United States
facility: Site # 001802
state: Missouri
city: St. Louis
country: United States
facility: Site # 001838
state: Missouri
city: Las Vegas
country: United States
facility: Site # 001010
state: Nevada
city: Reno
country: United States
facility: Site # 001954
state: Nevada
city: Toms River
country: United States
facility: Site #001961
state: New Jersey
city: Kingston
country: United States
facility: Site # 001860
state: New York
city: New York
country: United States
facility: Site # 001041
state: New York
city: New York
country: United States
facility: Site # 001921
state: New York
city: New York
country: United States
facility: Site # 001910
state: New York
city: North Syracuse
country: United States
facility: Site # 001034
state: New York
city: Syracuse
country: United States
facility: Site # 001013
state: New York
city: Durham
country: United States
facility: Site # 001951
state: North Carolina
city: Bellevue
country: United States
facility: Merz Investigative Site # 001840
state: Ohio
city: Cleveland
country: United States
facility: Site # 001812
state: Ohio
city: Columbus
country: United States
facility: Site # 001826
state: Ohio
city: Tulsa
country: United States
facility: Site # 001815
state: Oklahoma
city: Bend
country: United States
facility: Site # 001916
state: Oregon
city: Medford
country: United States
facility: Site # 001839
state: Oregon
city: Collegeville
country: United States
facility: Site #001000
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site # 001959
state: Pennsylvania
city: Wynnewood
country: United States
facility: Site #001032
state: Pennsylvania
city: Spartanburg
country: United States
facility: Site # 001893
state: South Carolina
city: Chattanooga
country: United States
facility: Site # 001922
state: Tennessee
city: Columbia
country: United States
facility: Site # 001889
state: Tennessee
city: Memphis
country: United States
facility: Site # 001831
state: Tennessee
city: Nashville
country: United States
facility: Site # 001836
state: Tennessee
city: Bedford
country: United States
facility: Merz Investigative Site # 001055
state: Texas
city: Bedford
country: United States
facility: Site # 001055
state: Texas
city: Bedford
country: United States
facility: Site # 001037
state: Texas
city: Dallas
country: United States
facility: Site # 001817
state: Texas
city: Dallas
country: United States
facility: Site # 001809
state: Texas
city: Houston
country: United States
facility: Site # 001022
state: Texas
city: Houston
country: United States
facility: Site # 001813
state: Texas
city: Houston
country: United States
facility: Site #001802
state: Texas
city: Tyler
country: United States
facility: Site # 001960
state: Texas
city: Alexandria
country: United States
facility: Site # 001962
state: Virginia
city: Fishersville
country: United States
facility: Site # 001980
state: Virginia
city: Virginia Beach
country: United States
facility: Site #001979
state: Virginia
city: Kirkland
country: United States
facility: Site # 001881
state: Washington
city: Spokane
country: United States
facility: Site # 001800
state: Washington
Study officials:
affiliation: Center for Neurological Restoration
name: Hubert H. Fernandez, MD, FAAN
role: PRINCIPAL_INVESTIGATOR
References: