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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Upper Limb Spasticity
- Sponsor
- Revance Therapeutics, Inc.
- Enrollment
- 83
- Locations
- 26
- Primary Endpoint
- Change From Baseline at Week 6 on the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG) Score
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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 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.
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
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Change From Baseline at Week 6 on the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG) Score
Time Frame: Week 6
Mean change from baseline at Week 6 in muscle tone measured with the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG) in one of the following: elbow, wrist, or finger flexors. Score range: 0 (Normal tone, no in tone) to 4 (Affected part{s} rigid in flexion or extension).
Physician Global Impression of Change (PGIC) Score
Time Frame: Week 6
Mean score on the Physician Global Impression of Change (PGIC) score at week 6. The PGIC is a single-item, 9-point scale that measures the physician's impression of improvement following treatment. Score range: -4 (Markedly worse) to +4 (Markedly improved).
Secondary Outcomes
- Change From Baseline at Weeks 6 and 12 on the Disability Assessment Scale (DAS) Functional Impairment(Weeks 6 and 12)
- Duration of Effect(Up to 36 weeks)
- Muscle Tone Improvement Responder Rate(Weeks 6 and 12)
- Physician Global Impression of Change (PGIC) Responder Rate(Weeks 6 and 12)