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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 Criteria

  • 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)

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Eligible subjects will be randomized (1:1:1:1) to one of four treatment groups: Group 1: DAXI 250 U (N=32); Group 2: DAXI 375 U (N=32); Group 3: DAXI 500 U (N=32); Group 4: Placebo (N=32).
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double Blinded. The subject, Sponsor, and study site research personnel will be blinded to the identity of the subject's assigned treatment.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
DAXI 250 U 		DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 250 U dose
  • Biological: 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
Experimental
DAXI 375 U 		DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 375 U
  • Biological: 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.
Experimental
DAXI 500 U 		DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 500 U
  • Biological: 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 Comparator
Placebo 		Placebo group
  • Other: 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.

More Details

Status
Completed
Sponsor
Revance Therapeutics, Inc.

Study Contact

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 primary aggregate posture

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.