Completed

NCT Number: NCT01313299

Dysport® Adult Upper Limb Spasticity

The purpose of this research study is to assess the efficacy of Dysport compared to placebo in improving muscle tone in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury.

Completed

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Key information

Conditions

Nervous System Disorders Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Université catholique de Louvain av Hippocrate 10, Brussels, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients - post stroke or brain injury
Modified Ashworth Scale ≥ 2
Ambulatory patients

Exclusion criteria

Previous treatment with botulinum toxin of any type within 4 months prior to study entry for any condition
Physiotherapy initiated less than 4 weeks before inclusion
Previous surgery, alcohol, phenol in upper limb
Neurological/neuromuscular disorders which may interfere with protocol evaluations

Treatment and study plan

Botulinum toxin type A

Biological

500 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle.

Other names: AbobotulinumtoxinA (Dysport®)

Placebo

Drug

I.M. (in the muscle) injection on day 1 of a single treatment cycle.

Primary outcomes

Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG)

Time frame: From Baseline (Day 1) to Week 4

MAS scale is used to assess muscle tone using a 6-point scale where: 0=No increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the part is flexed or extended, 1±Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the ROM, 2=Marked increase in muscle tone through most of the ROM but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part(s) rigid in flexion or extension. The MAS has been derived for analyses as follows: 0=0 ; 1=1; 1+=2; 2=3; 3=4 and 4=5.

Secondary outcomes

Physician's Global Assessment (PGA) of Treatment Response

Time frame: At Week 4

PGA is a 9-point scale used to assess global overall treatment response by the investigator (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved and +4: markedly improved).
Change From Baseline in DAS Score for the Principal Target of Treatment (PTT)

Time frame: From Baseline (Day 1) to Week 4

DAS is a 4-point scale used to determine the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain). DAS scale rating: 0=No disability, 1=Mild disability (noticeable but does not interfere significantly with normal activities), 2=Moderate disability (normal activities require increased effort and/or assistance) and 3=Severe disability (normal activities limited).

If subject chose 'Hygiene' as PTT the score collected will be between 0 and 3.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

A Phase III, Multicentre, Prospective, Double Blind, Randomised, Placebo Controlled Study, Assessing the Efficacy and Safety of Dysport® Intramuscular Injections Used for the Treatment of Upper Limb Spasticity in Adult Subjects With Spastic Hemiparesis Due to Stroke or Traumatic Brain Injury

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Mar 11, 2011
Registry last updated: Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed