Status:
COMPLETED
Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity
Lead Sponsor:
Revance Therapeutics, Inc.
Conditions:
Upper Limb Spasticity
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 Spa...
Detailed Description
Subjects will be randomly assigned to DAXI for Injection 250 U, DAXI for Injection 375 U, DAXI for Injection 500 U, or placebo group, respectively. Eligible subjects will have ULS characterized by a p...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
December 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2020
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT03821402
Start Date
December 12 2018
End Date
November 23 2020
Last Update
September 21 2023
Active Locations (26)
Enter a location and click search to find clinical trials sorted by distance.
1
Rancho Research Institute at Rancho Los Amigos National Rehab Center
Downey, California, United States, 90242
2
The Parkinsons and Movement Disorder Institute
Fountain Valley, California, United States, 92708-5153
3
Collaborative Neuroscience Network LLC
Long Beach, California, United States, 90806
4
SC3 Research
Pasadena, California, United States, 91105