Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT01313299
Recruitment Status : Completed
First Posted : March 11, 2011
Results First Posted : October 23, 2015
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Nervous System Disorders Biological: Botulinum toxin type A Drug: Placebo Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : August 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Dysport 500 U Biological: Botulinum toxin type A
500 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Other Name: AbobotulinumtoxinA (Dysport®)
Experimental: Dysport 1000 U Biological: Botulinum toxin type A
1000 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Other Name: AbobotulinumtoxinA (Dysport®)
Placebo Comparator: Placebo Drug: Placebo
I.M. (in the muscle) injection on day 1 of a single treatment cycle.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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).

  2. 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.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01313299


Locations
Show Show 40 study locations
Sponsors and Collaborators
Ipsen
Investigators
Layout table for investigator information
Study Director: Ipsen Study Director Ipsen
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01313299    
Other Study ID Numbers: Y-52-52120-145
2010-019069-28 ( EudraCT Number )
First Posted: March 11, 2011    Key Record Dates
Results First Posted: October 23, 2015
Last Update Posted: August 8, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents