A Study to Compare the Safety and Efficacy of Dysport® and Botox® in Adults With Upper Limb Spasticity. — DIRECTION

Upper Limb Spasticity Clinical Trial

Official title:
A Multicentre, Interventional, Post-marketing, Randomised, Double-blind, Crossover Study to Evaluate the Clinical Safety and Efficacy of AbobotulinumtoxinA (Dysport®) in Comparison With OnabotulinumtoxinA (Botox®) When Treating Adults With Upper Limb Spasticity

Status Recruiting

Clinical Trial Summary

This study is aiming to demonstrate the non-inferiority of AbobotulinumtoxinA (aboBoNT-A) versus OnabotulinumtoxinA (onaBoNT-A) as the primary safety endpoint, and the superiority of aboBoNT-A over onaBoNT-A with respect to duration of response as the key secondary efficacy endpoint when used at optimal doses according to approved prescribing information of each product.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04936542
Study type	Interventional
Source	Ipsen
Contact	Ipsen Recruitment Enquiries
Phone	see email
Email	clinical.trials@ipsen.com
Status	Recruiting
Phase	Phase 4
Start date	June 23, 2021
Completion date	June 28, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02454803` - Attainment of Person-centred Goals After Botulinum Toxin Treatment for Upper Limb Spasticity in Real Life Practice
Completed	`NCT00945295` - Efficacy and Safety Study of Botulinum Neurotoxin A With Rehabilitation Versus Botulinum Neurotoxin A Alone in Treatment of Post-stroke Spasticity	N/A
Active, not recruiting	`NCT05956509` - Study of Intramuscular Injections of ABBV-950 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Spasticity	Phase 1/Phase 2
Completed	`NCT00465738` - IncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity	Phase 3
Completed	`NCT02321436` - Study to Assess Impact of Dysport Injections Early After Stroke on Upper Limb Spasticity Progression	Phase 4
Completed	`NCT00430196` - BOTOX® Versus Zanaflex® for the Treatment of Post-Stroke or Traumatic Brain Injury Upper Limb Spasticity	Phase 4
Completed	`NCT03821402` - Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity	Phase 2
Terminated	`NCT02888548` - Randomised, Evaluation-blinded, Crossover, Controlled Study Assessing Dynamic Hand Splinting in Adults With Post-stroke Hemiplegia (Orthox)	N/A
Completed	`NCT01863901` - Study Evaluating Treatment of Upper Limb Spasticity Using the Cryo-Touch III Device	N/A