Dose-escalating Safety and Preliminary Efficacy of DaxibotulinumtoxinA for Injection in Cervical Dystonia
- Conditions
- Torticollis (Spasmodic)
- Interventions
- Biological: DaxibotulinumtoxinA
- Registration Number
- NCT02706795
- Lead Sponsor
- Revance Therapeutics, Inc.
- Brief Summary
This is an open-label, dose-escalation study to assess the safety and preliminary efficacy of daxibotulinumtoxinA in subjects with isolated cervical dystonia (CD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
- Meets diagnostic criteria for isolated cervical dystonia
- Has moderate severity with a baseline Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - Total score of at least 20 and a TWSTRS-Severity subscale score or at least 15
- Has been using stable doses of focal dystonia medications for at least 3 months and willing to continue through end of study
- Cervical dystonia attributable to an underlying etiology, such as traumatic torticollis or tardive torticollis; predominant retrocollis or anterocollis cervical dystonia
- Significant dystonia in other body areas, or is currently being treated with botulinum toxin for dystonia in other areas than isolated cervical dystonia
- Neurological abnormalities other than cervical dystonia
- History of severe dysphagia or aspiration, or current clinically significant swallowing disorder
- Previous neck surgery, phenol injection to the neck muscles, myotomy or denervation surgery in the neck/shoulder region, or intrathecal baclofen
- Marked limitation on passive range of motion that suggests contractures or other structural abnormality, e.g. cervical contractures or cervical spinal deformity
- Profound atrophy of cervical musculature
- Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
- Suboptimal efficacy response to any prior botulinum toxin type A product, when a previous treatment produced more optimal therapeutic response, as judged subjectively by the Investigator
- Previous treatment with any botulinum toxin product for any condition within the 6 months prior to Screening and during the study; presence of any blood coagulation disorder; or on anticoagulation treatment with international normalized ratio (INR) > 3.5
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description daxibotulinumtoxinA (DAXI) for injection DaxibotulinumtoxinA DAXI for injection
- Primary Outcome Measures
Name Time Method Improvement of dystonia as measured by change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - Total Score Week 4
- Secondary Outcome Measures
Name Time Method Change from baseline in TWSTRS subscale scores (Severity, Disability and Pain) 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 Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24 Percentage of responders showing improvement on Clinical Global Impression of Change (CGIC) Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24 Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS) - Total Score 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 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) Post-treatment: Weeks 4, 6, 12, 16, 20, 24
Trial Locations
- Locations (13)
University of South Florida
🇺🇸Tampa, Florida, United States
Colorado Springs Neurological Associates
🇺🇸Colorado Springs, Colorado, United States
Precision Research Organization
🇺🇸Miami Lakes, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Florida Center for Movement Disorders & Neurorestoration
🇺🇸Gainesville, Florida, United States
Parkinson's Disease Center and Movement Disorder Clinic
🇺🇸Houston, Texas, United States
The Parkinson's & Movement Disorder Institute
🇺🇸Fountain Valley, California, 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
Coastal Neurology
🇺🇸Port Royal, South Carolina, United States
Riverhills Healthcare, Inc.
🇺🇸Cincinnati, Ohio, United States
Wake forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States