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Dysport® Adult Upper Limb Spasticity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01313299
First received: March 10, 2011
Last updated: September 23, 2015
Last verified: September 2015
Results First Received: August 11, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Nervous System Disorders
Interventions: Drug: Botulinum type A toxin (Dysport®)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This multicenter study was conducted in 34 investigational sites. Subjects screened were 281 and randomised and treated were 243.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo intramuscular injection single treatment cycle on day 1
Dysport 500 U Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
Dysport 1000 U Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1

Participant Flow:   Overall Study
    Placebo   Dysport 500 U   Dysport 1000 U
STARTED   81   81   81 
COMPLETED   74   78   77 
NOT COMPLETED   7   3   4 
Adverse Event                3                1                1 
Lost to Follow-up                1                0                0 
Protocol Violation                2                0                0 
Withdrawal by Subject                1                0                2 
Family reason and moved out of state                0                2                0 
Lack of subject compliance                0                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Placebo intramuscular injection single treatment cycle on day 1
Dysport 500 U Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
Dysport 1000 U Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
Total Total of all reporting groups

Baseline Measures
   Placebo   Dysport 500 U   Dysport 1000 U   Total 
Overall Participants Analyzed 
[Units: Participants]
 81   81   81   243 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.9  (13.8)   52.8  (12.8)   53.2  (13.8)   52.9  (13.4) 
Gender 
[Units: Participants]
       
Female   31   28   28   87 
Male   50   53   53   156 
Race/Ethnicity, Customized 
[Units: Participants]
       
Asian   1   3   2   6 
Black/African American   9   7   11   27 
Caucasian/White   71   70   67   208 
Multiple   0   1   1   2 
Ethnicity 
[Units: Participants]
       
Hispanic/Latino   5   3   10   18 
Not Hispanic/Latino   76   78   71   225 
Body Mass Index (BMI) [1] 
[Units: Kg/m2]
Mean (Standard Deviation)
 26.78  (5.38)   27.63  (4.61)   27.58  (5.51)   27.33  (5.17) 
[1] Placebo: N=78, Dysport 500 U: N=80, and Dysport 1000 U: N=80.
Modified Ashworth Scale (MAS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 3.9  (0.4)   3.9  (0.5)   3.9  (0.4)   3.9  (0.4) 
[1]

MAS scale is used to assess muscle tone (MT) using a 6-point scale where:0=No increase in MT, 1=Slight increase in MT,1±=Slight increase in MT manifested by a catch followed by minimal resistance throughout remainder of ROM,2=Marked increase in MT through most of ROM but affected part easily moved,3=Considerable increase in MT 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.

Placebo:N=79, Dysport 500U:N=80 & Dysport 1000U:N=79.

Disability Assessment Scale (DAS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.6  (0.5)   2.6  (0.5)   2.5  (0.5)   2.6  (0.5) 
[1]

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

Placebo: N=79, Dysport 500 U: N=80 and Dysport 1000 U: N=79.



  Outcome Measures
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1.  Primary:   Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG)   [ Time Frame: From Baseline (Day 1) to Week 4 ]

2.  Secondary:   Physician's Global Assessment (PGA) of Treatment Response   [ Time Frame: At Week 4 ]

3.  Secondary:   Change From Baseline in DAS Score for the Principal Target of Treatment (PTT)   [ Time Frame: From Baseline (Day 1) to Week 4 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Medical Director, Neurology
Organization: Ipsen
phone: clinical.trials@ipsen.com
e-mail: clinical.trials@ipsen.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01313299     History of Changes
Other Study ID Numbers: Y-52-52120-145
2010-019069-28 ( EudraCT Number )
Study First Received: March 10, 2011
Results First Received: August 11, 2015
Last Updated: September 23, 2015
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Russia: Ministry of Health of the Russian Federation
Belgium: Federal Agency for Medicinal Products and Health Products
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Italy: The Italian Medicines Agency
Czech Republic: State Institute for Drug Control
Slovakia: State Institute for Drug Control