Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity

Completed · Phase 2 · Has a placebo group

Conditions studied: Upper Limb Spasticity

In brief

This is a randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging, trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Upper Limb Spasticity in Adults After Stroke or Traumatic Brain Injury. The study will be conducted in the U.S.A., approximately 128 adult subjects from approximately 30 study centers will be randomly assigned (1:1:1:1) to one of four treatment groups. The study consists of a 21-day screening period, a treatment visit and follow-up visits. 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.

Key facts

Study ID

NCT03821402

Run by

Revance Therapeutics, Inc.

People needed

83

Starts

2018-12-12

Expected to finish

2020-11-23

Last updated by the study team

2023-09-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 to 75 years of age
• 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

You may not qualify if…

• Upper limb spasticity attributable to an etiology other than stroke or TBI.
• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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