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

This study has been completed.
Sponsor:
Collaborator:
Registrat-Mapi
Information provided by (Responsible Party):
Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01287247
First received: January 28, 2011
Last updated: October 23, 2013
Last verified: October 2013
  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

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals, LLC:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 688
Study Start Date: February 2011
Study Completion Date: April 2013
Primary Completion Date: April 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:
  • Xeomin®
  • incobotulinumtoxinA
  • botulinum toxin
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:
  • Xeomin®
  • incobotulinumtoxinA
  • botulinum toxin

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
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287247

  Show 70 Study Locations
Sponsors and Collaborators
Merz Pharmaceuticals, LLC
Registrat-Mapi
Investigators
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: October 23, 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 April 15, 2014