Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 3/15/2019 |
| Start Date: | December 12, 2018 |
| End Date: | August 24, 2020 |
| Contact: | Daniel Snyder, PhD |
| Email: | dsnyder@revance.com |
| Phone: | 510-742-3523 |
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging, Multi-Center 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
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 study is
expected to last approximately 2 years, and the duration of individual subject participation
will vary.
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 study is
expected to last approximately 2 years, and the duration of individual subject participation
will vary.
Subjects will be randomly assigned to DAXI for Injection high dose, DAXI for Injection medium
dose, DAXI for Injection low dose, or placebo group, respectively. Eligible subjects will
have ULS characterized by a primary aggregate posture
dose, DAXI for Injection low dose, or placebo group, respectively. Eligible subjects will
have ULS characterized by a primary aggregate posture
Inclusion Criteria:
- 18 to 70 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)
We found this trial at
8
sites
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