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

Conditions

• Blepharospasm
• Cervical Dystonia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date

Feb 28, 2011

Status verified

Apr 2015

Primary completion

Apr 30, 2013

Completion

Apr 30, 2013

Study Design

Enrollment

688 participants (actual)

Arms

• Arm: 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.
• Arm: Blepharospasm
  The target populations for which the sample size calculations are based are adult subjects aged ≥ 18 years with clinical diagnoses of blepharospasm.

Primary Outcome Measure

Determination of injection patterns and techniques [ Time Frame: Two treatment cycles (approximately 6 months/subject) ]

Locations (70)

Find similar trials in Cullman, AL

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