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CD Flex: An Open-Label, Non-Inferiority Study Evaluating the Efficacy and Safety of Two Injection Schedules of Xeomin (incobotulinumtoxinA) [Short Flex vs. Long Flex] in Subjects with Cervical Dystonia with < 10 Weeks of Benefit from OnabotulinumtoxinA Treatment MUS 60201 4073 1
Dystonia is a movement disorder characterized by sustained, involuntary muscle contractions which frequently causes twisting and repetitive movements or abnormal postures. Cervical dystonia (CD) is the most commonly described form of focal dystonia (abnormality involving a single area of the body). Xeomin (botulinum toxin type A), the study drug, has been shown to be effective and safe in the treatment of CD with two Phase III trials. Current practice in the treatment of CD with onabotulinumtoxinA (Botox) injection is to inject patients every 3 months. However, not all patients receive benefit from injections for the duration of 3 months. This study is designed to examine a shorter treatment interval with Xeomin injections and compare to the standard interval to determine if there is a difference from an efficacy standpoint (i.e., do the patients receive continuous benefit versus peaks and valleys) and if more frequent dosing leads to more development of botulinum toxin resistance. This study will evaluate if shorter dosing intervals is non-inferior to standard or longer dosing intervals by using the Toronto Western Spasmodic Torticollis Scale (TWSTRS) at control Visit 4 weeks post the the 8th injection. Secondary outcomes will evaluate efficacy, onset and offste of efficacy, safety and immunology. The primary efficacy variable will be defined as the change from study entry baseline in the TWSTRS-Severity score assessed at the 4-week control visti after the 8th injection (PPS sample). An analysis of covariance (ANCOVA) will be used for the primary efficacy analysis. All analysis of secondary endpoints for efficacy will be considered exploratory.
Phase 4 - refines the treatment to become part of standard care.
Inclusion and Exclusion Criteria
- Documented clinical diagnosis of idiopathic or genetic Cervical Dystonia
- Current treatment with botulinum toxin of any type for any other indication (including aesthetic indications) and for any body region during the study.
- Merz Investigative Site #001219, Los Angeles, California, 90033
- D. Truong, MD, Fountain Valley, California, 92708
- Merz Investigative Site 001017, Fountain Valley, California, 92708
- Merz Investigative Site #1033, Portland, Oregon, 97239
- Merz Investigative Site #1251, Portland, Oregon, 97239
- Merz Investigative Site #1270, Seattle, Washington, 98122
- Merz Investigative Site #001224, Kirkland, Washington, 98034
- Merz Investigative Site #001223, Dallas, Texas, 75231
- Merz Investigative Site #1074, Dallas, Texas, 75214
- Merz Investigative Site # 001216, Houston, Texas, 77030
- Merz Investigative Site# 001266, Houston, Texas, 77030
- Merz Investigative Site #001220, Tulsa, Oklahoma, 74136
- Merz Investigative Site #001110, Overland Park, Kansas, 66211
- Merz Investigative Site # 01069, Des Moines, Iowa, 50309
- Merz Investigative Site # 0001275, Eagan, Minnesota, 55121
- Merz Investigative Site #001210, St. Louis, Missouri, 63110
- Merz Investigative Site #1250, St. Louis, Missouri, 63104
- Merz Investigative Site #001215, Chicago, Illinois, 60612
- Merz Investigative Site# 01255, Chicago, Illinois, 60611
- Merz Investigative Site #01263, Fort Wayne, Indiana, 46804
- Merz Investigative Site #1265, Cincinnati, Ohio, 45219
- Merz Investigative Site #001055, Atlanta, Georgia, 30329