This is an open-label, dose-escalation study to assess the safety and preliminary efficacy of daxibotulinumtoxinA in subjects with isolated cervical dystonia (CD).
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Low, mid, and high dose sequential treatments of daxibotulinumtoxinA in dose-escalation safety and efficacy study
The Parkinson's & Movement Disorder Institute
Fountain Valley, California, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States
University of Florida Center for Movement Disorders & Neurorestoration
Improvement of dystonia as measured by change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - Total Score
Time frame: Week 4
Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS) - Total Score
Time frame: Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24
Change from baseline in TWSTRS subscale scores (Severity, Disability and Pain)
Time frame: Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24
Duration of effect based on number of weeks from treatment until return of symptoms that warrant treatment
Time frame: Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24
Percentage of treatment responders with at least a 20% reduction in the TWSTRS - Total score post-treatment
Time frame: Weeks 2, 4, 6, 9, 12, 16, 20, 24
Patient-rated quality of life measurement based upon change from baseline of the Cervical Dystonia Impact Profile Scale (CDIP-58)
Time frame: Post-treatment: Weeks 4, 6, 12, 16, 20, 24
Percentage of responders showing improvement on Clinical Global Impression of Change (CGIC)
Time frame: Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24
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Gainesville, Florida, United States
Precision Research Organization
Miami Lakes, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Kansas City Bone & Joint Clinic
Overland Park, Kansas, United States
The NeuroMedical Center Clinic
Baton Rouge, Louisiana, United States
Wake forest Baptist Health
Winston-Salem, North Carolina, United States
...and 3 more locations