Cervical DystoniaXCiDaBLENCT01287247
Trial Evaluating Xeomin® (incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States
An observational study of Cervical Dystonia and Blepharospasm, run by Merz North America, Inc. at 70 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Dystonia, Blepharospasm
- What is being tested?
- Xeomin®
- How many people
- 688 participants
- Where
- 70 sitesUnited States
- Study dates
- Feb 2011to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
70 sites in 1 country.
70 sites in 1 country
United States70 sites
Site # 001962
Alexandria, Virginia, 22311
Site # 001849
Baltimore, Maryland, 21287
Site # 001047
Baton Rouge, Louisiana, 70810
Merz Investigative Site # 001055
Bedford, Texas, 76021
Site # 001055
Bedford, Texas, 76021
Site # 001037
Bedford, Texas, 76022
Merz Investigative Site # 001840
Bellevue, Ohio, 44811
Site # 001916
Bend, Oregon, 97701
Site # 001028
Bloomington, Minnesota, 55431
Site # 001803
Boca Raton, Florida, 33486
Site # 001053
Boston, Massachusetts, 02114
Site # 001922
Chattanooga, Tennessee, 37411
Site # 001972
Chicago, Illinois, 60611
Site # 001812
Cleveland, Ohio, 44195
Site #001000
Collegeville, Pennsylvania, 19426
Site # 001889
Columbia, Tennessee, 38401
Site # 001826
Columbus, Ohio, 43215
Site #001052
Cullman, Alabama, 35058
Site # 001817
Dallas, Texas, 75214
Site # 001809
Dallas, Texas, 75231
Site # 001802
Des Peres, Missouri, 63131
Site # 001951
Durham, North Carolina, 27710
Site # 001834
Eagan, Minnesota, 55122
Site #001046
Encinitas, California, 92024
Site # 001980
Fishersville, Virginia, 22939
Site # 001822
Fountain Valley, California, 92708
Site #001057
Glenview, Illinois, 60026
Site # 001022
Houston, Texas, 77030
Site # 001813
Houston, Texas, 77030
Site #001802
Houston, Texas, 77030
Site # 001860
Kingston, New York, 12401
Site # 001881
Kirkland, Washington, 98034
Site # 001852
La Jolla, California, 92037
Site #001978
Lake Bluff, Illinois, 60044
Site # 001010
Las Vegas, Nevada, 89102
Merz Investigative Site #001986
Los Angeles, California, 90095
Site # 001924
Los Gatos, California, 95032
Site # 001839
Medford, Oregon, 97504
Site # 001831
Memphis, Tennessee, 38163
Site # 001957
Minneapolis, Minnesota, 55455
Site # 001995
Munster, Indiana, 46321
Site # 001836
Nashville, Tennessee, 37203
Site # 001977
New Haven, Connecticut, 06520
Site # 001041
New York, New York, 10003
Site # 001921
New York, New York, 10011
Site # 001910
New York, New York, 10029
Site # 001005
Newport Beach, California, 92663
Site # 001805
North Palm Beach, Florida, 33408
Site # 001034
North Syracuse, New York, 13212
Site # 001833
Overland Park, Kansas, 66211
Site # 001959
Philadelphia, Pennsylvania, 19107
Site # 001954
Reno, Nevada, 89509
Site # 001816
Roseville, Michigan, 48066
Site # 001973
Sacramento, California, 95817
Site # 001955
Sarasota, Florida, 34239
Study site
Scottsdale, Arizona, 85258
Site # 001893
Spartanburg, South Carolina, 29303
Site # 001800
Spokane, Washington, 99204
Site # 001838
St Louis, Missouri, 63141
Site # 001823
St. Petersburg, Florida, 33713
Site # 001013
Syracuse, New York, 13210
Site #001961
Toms River, New Jersey, 08755
Site # 001974
Tucson, Arizona, 85713
Site # 001815
Tulsa, Oklahoma, 74136
Site # 001960
Tyler, Texas, 75701
Site #001979
Virginia Beach, Virginia, 23454
Site # 001848
Warren, Michigan, 48088
Site # 001901
Washington D.C., District of Columbia, 20007
Site # 001820
Winfield, Illinois, 60190
Site #001032
Wynnewood, Pennsylvania, 19096
About this study
Official title: Prospective, Observational Trial Evaluating Xeomin®(incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States
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).
Read the 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®
- Conditions
- Cervical Dystonia, Blepharospasm
- Being tested
- Xeomin®
- Keywords
- Cervical dystonia, Blepharospasm
- Medical subject headings
- Torticollis, Blepharospasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xeomin®Biological
Also called incobotulinumtoxinA, botulinum toxin
Xeomin® (incobotulinumtoxinA) at a dose determined by the physician based upon his/her clinical experience with botulinum toxin.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Xeomin® | |
| Blepharospasm | The target populations for which the sample size calculations are based are adult subjects aged ≥ 18 years with clinical diagnoses of blepharospasm. Receives: Biological: Xeomin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two treatment cycles (approximately 6 months/subject)
Secondary outcomes (1)
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
Measured: Two treatment cycles (approximately 6 months/subject)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical DystoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 688 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Registrat-Mapi
- Responsible party
- Sponsor
- Investigators
- Hubert H. Fernandez, MD, FAAN, Principal investigator, Center for Neurological Restoration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287247
- Sponsor's protocol ID
- MRZ 60201-4066-5
- Acronym
- XCiDaBLE
- Status last verified
- Apr 2015
- First submitted
- 28 Jan 2011
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational Trial Evaluating Xeomin®(incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States
- ClinicalTrials.gov ID
- NCT01287247
- Acronym / sponsor ID
- XCiDaBLE / MRZ 60201-4066-5
- Conditions
- Cervical Dystonia, Blepharospasm
- Keywords
- Cervical dystonia, Blepharospasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 688 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Registrat-Mapi
- Study start
- Feb 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 1 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Dystonia | – | Biological: Xeomin®The target populations for which the sample size calculations are based are adult subjects aged ≥ 18 years with clinical diagnoses of cervical dystonia. |
| Blepharospasm | – | Biological: Xeomin®The target populations for which the sample size calculations are based are adult subjects aged ≥ 18 years with clinical diagnoses of blepharospasm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xeomin®Also: incobotulinumtoxinA, botulinum toxinXeomin® (incobotulinumtoxinA) at a dose determined by the physician based upon his/her clinical experience with botulinum toxin. | Biological | Blepharospasm, Cervical Dystonia |
Primary outcome
Determination of injection patterns and techniques
Time frame: Two treatment cycles (approximately 6 months/subject)
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.
1 secondary outcome
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
Time frame: Two treatment cycles (approximately 6 months/subject)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
Related trials for Cervical Dystonia
Enrolling by invitationPhase 2
Accelerating TMS for Cervical Dystonia
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A Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia
Dystonia
Not yet recruitingObservational study
Assessment of Cervical Range of Motion Restrictions in Infants With Arthrogenic Torticollis - A Feasibility Study
Torticollis (Arthrogenic)
Recruiting
Effect of Vibro-tactile Stimulation Intensity on Head Posture in Cervical Dystonia
Cervical Dystonia
Active, not recruitingObservational study
An Observational Study of Individuals With Isolated Dystonia
Isolated/Primary Dystonia That Affects More Than One Region of the Body
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hubert H. Fernandez, MD, FAAN principal investigator
Center for Neurological Restoration
70 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Dystonia and Blepharospasm, run by Merz North America, Inc. at 70 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of injection patterns and techniques (time frame: Two treatment cycles (approximately 6 months/subject)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2015.