Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity
NCT ID: NCT03821402
Last Updated: 2023-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
83 participants
INTERVENTIONAL
2018-12-12
2020-11-23
Brief Summary
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The protocol was amended and the study was completed with fewer subjects than described in the initial protocol due to impact of COVID-19 on enrollment.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DAXI 250 U
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 250 U dose
DAXI for injection 250 U
DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline
DAXI 375 U
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 375 U
DAXI for injection 375 U
DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.
DAXI 500 U
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 500 U
DAXI for injection 500 U
DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline
Placebo
Placebo group
Placebo
Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution.
Interventions
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DAXI for injection 250 U
DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline
DAXI for injection 375 U
DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.
DAXI for injection 500 U
DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline
Placebo
Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent including authorization to release health information
* Focal upper limb spasticity (ULS) after a stroke (as defined by WHO criteria) or traumatic brain injury (TBI), last stroke or TBI \> 24 weeks prior to Screening
* ULS with the primary aggregate posture
* Moderate to severe ULS with a MAS score ≥ 2 at the elbow, wrist, and finger flexors
* Moderate to severe functional disability (Disability Assessment Score \[DAS\] score ≥2) on the principal target of treatment
* Has sufficient cognitive and communication ability to be able to give informed consent
Exclusion Criteria
* Bilateral upper limb paresis or quadriplegia.
* Initiated in physiotherapy of the upper extremities ≤ 30 days prior to Screening or planned to start physiotherapy of the upper extremities during the course of the study.
* Previous or planned treatment of the spastic upper limb with phenol, alcohol injection, or surgery
* Profound muscular atrophy or fixed contracture leading to marked limitation on range of motion
* Prior treatment with intrathecal baclofen
* Any neuromuscular neurologic conditions (amyotrophic lateral sclerosis, Lambert- Eaton, myasthenia gravis)
18 Years
75 Years
ALL
No
Sponsors
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Revance Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Rancho Research Institute at Rancho Los Amigos National Rehab Center
Downey, California, United States
The Parkinsons and Movement Disorder Institute
Fountain Valley, California, United States
Collaborative Neuroscience Network LLC
Long Beach, California, United States
SC3 Research
Pasadena, California, United States
Yale University
Fairfield, Connecticut, United States
Waterbury Neurologists
Middlebury, Connecticut, United States
Ki Health Partners LLC DBA New England Institute for Clinical Research
Stamford, Connecticut, United States
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, United States
Parkinsons Disease and Movement Disorders Center
Boca Raton, Florida, United States
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida, United States
Infinity Clinical Research
Hollywood, Florida, United States
Parkinsons Disease Treatment Center of Southwest Florida
Port Charlotte, Florida, United States
Shirley Ryan AbilityLab
Chicago, Illinois, United States
Kansas Institute of Research
Overland Park, Kansas, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Rusk Rehabilitation Hospital
Columbia, Missouri, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Carolinas Rehabilitation
Charlotte, North Carolina, United States
Wake Forest University School of Medicine
Salem, North Carolina, United States
MossRehab
Elkins Park, Pennsylvania, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
North Texas Institute of Neurology and Headache
Frisco, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1820203
Identifier Type: -
Identifier Source: org_study_id
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