Research Study Summary
Cervical Dystonia Study
You are being asked to participate in this research study because you have cervical dystonia (CD). Botulinum toxin treatment can be offered as a treatment option for the treatment of CD. The current practice for botulinum toxin injection treatment is to inject patients every 3 months. However, not all patients receive benefit from botulinum toxin injections every 3 months. In a recent survey, approximately 45% of patients report that they would prefer a treatment cycle of less than 10 weeks.
This study will compare Xeomin®, a botulinum toxin treatment, in shorter treatment intervals (Short Flex dosing) to the standard interval dosing (Long Flex dosing) to determine if more frequent dosing leads to development of botulinim toxin resistance (making treatment with botulinum toxin less effective). Xeomin® is approved by the United States Food and Drug Administration (FDA) for the treatment of Cervical Dystonia or CD. The use of Short Flex Xeomin® is investigational. An investigational use is one that is not approved by the FDA.
The purpose of this research study is to evaluate the effectiveness of the Short Flex dosing of Xeomin compared to the Long Flex dosing regimen of Xeomin®, using questionnaires that ask subjects to rate symptoms of CD. Subjects will be asked these questionnaires regularly throughout the study. Some of the questions will be asked while the subject is at the research site, and some questions will be asked when a subject calls into an Interactive Voice Response System (IVRS).
Because this is a research study, Xeomin® will only be given to you only during this study and not after the study is over. Treatment with Xeomin® may be available from a doctor outside this research study.
Your participation in this study will last approximately 30 - 32 months and include 12 - 17 study visits to the study center, depending on whether you receive Xeomin® Short Flex or Xeomin® Long Flex.
For your time and inconvenience related to your participation in this study, you will be paid for the study visits you complete according to the following schedule: $50.00 for each site visit you complete.
Patient Inclusion Criteria:
This is a partial list of inclusion criteria. Patients will need to meet other criteria for enrollment into the study.
- Male or female subject aged > 18 years and < 81 years
- Documented clinical diagnosis of idiopathic or genetic CD
- Subject on a stable dose of other medications (if any) used for dystonia treatment (e.g., anticholinergics, baclofen and benzodiazepines) for 30 days prior to baseline
- Previous onabotulinumtoxinA (Botox®) injection history
- At least 12 weeks have elapsed since the most recent onabotulinumtoxinA injection
Patient Exclusion Criteria:
This is a partial list of exclusion criteria. Patients will be subject to other exclusion criteria for enrollment into the study.
- Previous treatment with rimabotulinumtoxinB (Myboloc®)
- Previous treatment with abobotulinumtoxinA (Dysport®)
- Previous treatment with incobotulinumtoxinA (Xeomin®)
- Nursing mother/pregnancy
- Known current alcoholism or other drug abuse/dependence
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