Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity — JUNIPER

Upper Limb Spasticity Clinical Trial

Official title:
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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03821402
Study type	Interventional
Source	Revance Therapeutics, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	December 12, 2018
Completion date	November 23, 2020

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See also
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Completed	`NCT02321436` - Study to Assess Impact of Dysport Injections Early After Stroke on Upper Limb Spasticity Progression	Phase 4
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