Trial Evaluating Xeomin® (incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States (XCiDaBLE)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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).
| Condition | Intervention |
|---|---|
|
Cervical Dystonia Blepharospasm |
Biological: Xeomin® |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prospective, Observational Trial Evaluating Xeomin®(incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States |
- Determination of injection patterns and techniques [ Time Frame: Two treatment cycles (approximately 6 months/subject) ] [ Designated as safety issue: No ]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.
- 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) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 973 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
Biological: Xeomin®
Xeomin® (incobotulinumtoxinA) at a dose determined by the physician based upon his/her clinical experience with botulinum toxin.
Other Names:
|
|
Blepharospasm
The target populations for which the sample size calculations are based are adult subjects aged ≥ 18 years with clinical diagnoses of blepharospasm.
|
Biological: Xeomin®
Xeomin® (incobotulinumtoxinA) at a dose determined by the physician based upon his/her clinical experience with botulinum toxin.
Other Names:
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
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.
Contacts and Locations
Show 70 Study Locations| Principal Investigator: | Hubert H. Fernandez, MD, FAAN | Center for Neurological Restoration |
More Information
No publications provided
| Responsible Party: | Merz Pharmaceuticals, LLC |
| ClinicalTrials.gov Identifier: | NCT01287247 History of Changes |
| Other Study ID Numbers: | MRZ 60201-4066-5 |
| Study First Received: | January 28, 2011 |
| Last Updated: | April 19, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Merz Pharmaceuticals, LLC:
|
Cervical dystonia Blepharospasm |
Additional relevant MeSH terms:
|
Blepharospasm Dystonia Dystonic Disorders Torticollis Eyelid Diseases Eye Diseases Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Movement Disorders |
Central Nervous System Diseases Botulinum Toxins, Type A Botulinum Toxins Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013