Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Revance Therapeutics, Inc.
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
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
