Dysport® Adult Upper Limb Spasticity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01313299
Recruitment Status : Completed
First Posted : March 11, 2011
Results First Posted : October 23, 2015
Last Update Posted : March 7, 2017
Information provided by (Responsible Party):

March 10, 2011
March 11, 2011
August 11, 2015
October 23, 2015
March 7, 2017
August 2011
September 2013   (Final data collection date for primary outcome measure)
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.
Intensity of muscle tone rated by Modified Ashworth Scale [ Time Frame: Week 4 ]
Complete list of historical versions of study NCT01313299 on Archive Site
  • 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.

  • Physician's Global Assessment of treatment response [ Time Frame: Week 4 ]
  • Upper limb passive function, using the Disability Assessment Scale [ Time Frame: Baseline and week 4 ]
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Dysport® Adult Upper Limb Spasticity
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
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.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Nervous System Disorders
  • Drug: Botulinum type A toxin (Dysport®)
    500 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle.
  • Drug: Botulinum type A toxin (Dysport®)
    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.
  • Experimental: Dysport 500 U
    Intervention: Drug: Botulinum type A toxin (Dysport®)
  • Experimental: Dysport 1000 U
    Intervention: Drug: Botulinum type A toxin (Dysport®)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2013
September 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   France,   Hungary,   Italy,   Poland,   Russian Federation,   Slovakia,   United States
2010-019069-28 ( EudraCT Number )
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Study Director: Ipsen Study Director Ipsen
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP