Dysport® Adult Upper Limb Spasticity

Nervous System Disorders Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01313299
• Other study ID #: Y-52-52120-145
• Secondary ID: 2010-019069-28
• Status: Completed
• Phase: Phase 3
• Start date: August 2011
• Est. completion date: September 2013

Study information

• Verified date: September 2022
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Nervous System Diseases
• Nervous System Disorders

Intervention

Biological:
• Botulinum toxin type A
500 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle.
• Botulinum toxin type A
1000 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle.

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

Locations

Country	Name	City	State
Belgium	Université catholique de Louvain av Hippocrate 10	Bruxelles
Belgium	Clinique Universitaire	Yvoir
Czechia	Neurologicka klinika, Olomouc	Olomouc
Czechia	Charles University in Prague	Praha 2
France	CHU Jean MINJOZ	Besançon
France	CHU Brest	Brest
France	Centre de Réadaptation de Coubert	Coubert
France	Centre Hospitalier Albert Chenevier-Hopital Henri Mondor	Créteil
France	Hopital Raymond Poincarré	Garches
France	Hôpital Sébastopol	Reims
France	CHU Strasbourg	Strasbourg
France	Hopital Rangueil	Toulouse
Hungary	National Institut for Medical Rehabilitation	Budapest
Hungary	Petz Aladar County Hospital	Gyor
Hungary	University of Szeged	Szeged
Italy	Azienda Hospedaliero	Catania
Italy	Policlinico Universitario Agostino Gemelli	Roma
Poland	Malopolskie Centrum Medyczne	Krakow
Poland	Krakowska Akademia Neurologii	Warszawa
Poland	Samodzielny Publiczny Centralny Szpital Kliniczny	Warszawa
Russian Federation	Medical Rehabilitation Center	Moscow
Russian Federation	Scientific Center of Neurology of RAMS	Moscow
Russian Federation	State University	St Petersburg
Slovakia	Derer's Hospital	Bratislava
Slovakia	Univerzitna nemocnica Bratislava	Bratislava
United States	Parkinson's Disease & Movement Disorders Center of Boca Raton	Boca Raton	Florida
United States	Univ of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	The Rehabilitation Institute of Chicago	Chicago	Illinois
United States	Southwestern Medical Center at Dallas	Dallas	Texas
United States	University of Texas	Dallas	Texas
United States	Rancho Los Amigos National Rehabilitation Center	Downey	California
United States	Associated Neurologist of Southern CT, PT	Fairfield	Connecticut
United States	University of North Texas HSC	Fort Worth	Texas
United States	University of Texas	Houston	Texas
United States	Vanderbilt University	Nashville	Tennessee
United States	Mount Sinai School of Medicine	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	University of Utah School of Medicine	Salt Lake City	Utah
United States	Design Neuroscience Miami	South Miami	Florida
United States	Wake Forest Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  France,  Hungary,  Italy,  Poland,  Russian Federation,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG)	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.	From Baseline (Day 1) to Week 4
Secondary	Physician's Global Assessment (PGA) of Treatment Response	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).	At Week 4
Secondary	Change From Baseline in DAS Score for the Principal Target of Treatment (PTT)	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.	From Baseline (Day 1) to Week 4