Dose-escalating Safety and Preliminary Efficacy of DaxibotulinumtoxinA for Injection in Cervical Dystonia
NCT ID: NCT02706795
Last Updated: 2019-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
37 participants
INTERVENTIONAL
2015-09-30
2017-07-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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SEQUENTIAL
TREATMENT
NONE
Study Groups
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daxibotulinumtoxinA (DAXI) for injection
DAXI for injection
DaxibotulinumtoxinA
Low, mid, and high dose sequential treatments of daxibotulinumtoxinA in dose-escalation safety and efficacy study
Interventions
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DaxibotulinumtoxinA
Low, mid, and high dose sequential treatments of daxibotulinumtoxinA in dose-escalation safety and efficacy study
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
30 Years
75 Years
ALL
No
Sponsors
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Revance Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nubia Kaba
Role: STUDY_DIRECTOR
Sponsor GmbH
Locations
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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
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
Riverhills Healthcare, Inc.
Cincinnati, Ohio, United States
Coastal Neurology
Port Royal, South Carolina, United States
Parkinson's Disease Center and Movement Disorder Clinic
Houston, Texas, United States
Countries
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References
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Jankovic J, Truong D, Patel AT, Brashear A, Evatt M, Rubio RG, Oh CK, Snyder D, Shears G, Comella C. Injectable DaxibotulinumtoxinA in Cervical Dystonia: A Phase 2 Dose-Escalation Multicenter Study. Mov Disord Clin Pract. 2018 Apr 26;5(3):273-282. doi: 10.1002/mdc3.12613. eCollection 2018 May-Jun.
Other Identifiers
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RT002-CL005
Identifier Type: -
Identifier Source: org_study_id
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