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Therapeutic Benefit of Incobotulinum Toxin A for Spasticity of the Triceps Surae in Patients With Multiple Sclerosis — GAITOX  

Multiple Sclerosis Clinical Trial

Official title:
Gaitox :Therapeutic Benefit of Incobotulinum Toxin A for Spasticity of the Triceps Surae in Patients With Multiple Sclerosis an Observational Study on Gait Spatiotemporal Parameters

Clinical Trial Summary

Introduction/Objectives: In this observational study, we assessed the benefit following an injection of 200 international units (IU) of incobotulinum toxinA in patients with multiple sclerosis (MS) with spasticity of the triceps surae (TS) at 6 weeks (peak efficacy of toxin) and at 3 months (cancellation of efficacy).

Methods: This study enrolled all MS patients willing to participate with Expanded Disability Status Scale (EDSS) scores of less than 6, who required toxin for management of focal spasticity of the TS. Treatment consisted of 200 IU of incobotulinum toxinA injected into the TS. Outcome measures were assessed before injection, at 6 weeks and 3 months post-injection, using the Goal Attainment Scale (GAS), Twelve Item MS Walking (MSWS-12) Scale, Timed Up and Go (TUG) Test, 6 Minute Walk Test (6MWT). Spatiotemporal gait data was obtained by GAITRite.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04265092
Study type Observational
Source Pôle Saint Hélier
Contact
Status Completed
Phase
Start date January 2014
Completion date January 2019
View Details
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