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Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity after Stroke or TBI (JUNIPER)

Clinical Trial Details

This study is a phase II study, which means the investigational drug is continuously being tested for safety and effectiveness. The purpose of this study is to help Researchers find out if an investigational drug, called daxibotulinumtoxinA (DAXI) for injection, is safe and useful to treat ULS in adults after stroke or major brain injury and if the effects last longer than the placebo. An investigational drug is one that is not approved by the United States (US) Food and Drug Administration (FDA) for use by the general public. 

In this research study, the investigational drug will be tested in study subjects with ULS and will be compared to placebo. Placebo is a substance that looks like the investigational drug but has no active drug in it. 

DAXI for injection is composed of purified botulinum toxin type A, and it is formulated with the novel stabilizing peptide RTP004, and it is injected. The placebo is identical to the investigational drug, except that it does not contain the botulinum toxin type A or any other active ingredient.

Key Eligibility: 

Inclusion Criteria: 

  • 18 to 70 years of age 
  • Focal upper limb spasticity after a stroke or traumatic brain injury (TBI), last stroke or TBI more than 24 weeks prior to screening 
  • ULS with the primary aggregate posture 
  • Moderate to severe upper limb spasticity at the elbow, wrist, and finger flexors 
  • 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) 
  • Bodyweight less than 60 kg 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Karen Wen
212-746-1857
kaw4003@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1810019685

ClinicalTrials.gov:

NCT03821402

Status

Open to Enrollment

Age Group

Adult

Sponsor