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Dysport® Pediatric Lower Limb Spasticity Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01249417
First received: November 25, 2010
Last updated: December 8, 2016
Last verified: December 2016
History of Changes
Results First Received: August 30, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Cerebral Palsy
Muscle Spasticity
Children
Interventions: Drug: Botulinum type A toxin (Dysport®)
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Each centre that participated in the study was expected to randomise between five and 25 subjects. It was planned to have at least two participating centres per country.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Screening details:

A total of 241 subjects were randomised to the study. The safety population included 239 subjects who were treated. Out of the 239 treated subjects, 4 subjects were excluded from the Intent-to-Treat (ITT) population because no MAS score was obtained at the baseline visit and/or at Week 4.

Reporting Groups
  Description
Dysport 10 U/Kg

10 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.

Botulinum type A toxin (Dysport®): I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Dysport 15 U/Kg

15 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.

Botulinum type A toxin (Dysport®): I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Placebo

Total volume to be injected per lower limb - 2ml. Either one or both lower limbs can be treated.

Placebo: I.M. injection on day 1 of a single treatment cycle.

Participant Flow for 2 periods

 Period 1:   Randomised Population
    Dysport 10 U/Kg   Dysport 15 U/Kg   Placebo
STARTED   80   80   81 
Treated [1]   80   80   79 
COMPLETED   79   79   77 
NOT COMPLETED   1   1   4 
Study treatment not received                0                0                2 
No MAS score at baseline and/or Week 4                1                1                2 
[1] Constitutes the safety population.

Period 2:   Treatment Phase - ITT Population
    Dysport 10 U/Kg   Dysport 15 U/Kg   Placebo
STARTED   79   79   77 
COMPLETED   78   75   73 
NOT COMPLETED   1   4   4 
Not specified                0                0                1 
Adverse Event                0                0                1 
Withdrawal by Subject                1                3                1 
Lost to Follow-up                0                1                1 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Baseline characteristic values were based on the ITT population, defined as all randomised subjects who received at least one injection of study treatment and who had a MAS score in the GSC assessed both at baseline and at Week 4.

Reporting Groups
  Description
Dysport 10 U/Kg Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
Dysport 15 U/Kg Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
Placebo Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
Total Total of all reporting groups

Baseline Measures
   Dysport 10 U/Kg   Dysport 15 U/Kg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 79   79   77   235 
Age 
[Units: Years]
Mean (Standard Deviation) 		 6  (3.3)   5.7  (3.2)   5.9  (3.5)   5.9  (3.3) 
Age, Customized 
[Units: Participants]
 		       
Children (2-9 years)   67   67   65   199 
Children (10-17 years)   12   12   12   36 
Gender 
[Units: Participants]
Count of Participants 		       
Female      45  57.0%      48  60.8%      48  62.3%      141  60.0% 
Male      34  43.0%      31  39.2%      29  37.7%      94  40.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants 		       
Hispanic or Latino      21  26.6%      21  26.6%      20  26.0%      62  26.4% 
Not Hispanic or Latino      58  73.4%      58  73.4%      57  74.0%      173  73.6% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
 		       
Black/African American   2   0   5   7 
Caucasian/White   57   60   55   172 
American Indian/Alaskan Native   1   0   0   1 
Multiple   19   19   17   55 
Botulinum toxin Status 
[Units: Participants]
 		       
Naive   40   41   41   122 
Non-naive   39   38   36   113 
Number of legs being treated 
[Units: Participants]
 		       
1 Leg injected   42   50   47   139 
2 Legs injected   37   29   30   96 
Gross Motor Function Classification System (GMFCS) [1] 
[Units: Participants]
 		       
GMFCS level 1   46   45   40   131 
GMFCS level 2   24   24   30   78 
GMFCS level 3   9   10   7   26 
[1] Participants were staged according to the following GMFCS criteria: level 1 (walks without limitations (best outcome)), level 2 (walks with limitations) and level 3 (walks using a hand held mobility device (worst outcome)). Only participants classified as GMFCS levels 1 to 3 were eligible for entry into the study.
Height 
[Units: Cm]
Mean (Standard Deviation) 		 117.1  (20.7)   111.6  (18.5)   114.6  (19.7)   114.4  (19.7) 
Weight 
[Units: Kg]
Mean (Standard Deviation) 		 23.1  (13.4)   21.1  (10.7)   22.6  (11.9)   22.3  (12.0) 
Body Mass Index (BMI) 
[Units: Kg/m2]
Mean (Standard Deviation) 		 15.8  (2.9)   16.1  (2.7)   16.2  (2.7)   16.0  (2.8) 
Modified Ashworth Scale (MAS) score [1] 
[Units: Units on a scale]
Mean (Standard Deviation) 		 3.1  (0.3)   3.1  (0.3)   3.2  (0.4)   3.1  (0.4) 
[1] The MAS is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. The Investigator graded muscle tone in the gastrocnemius-soleus complex (GSC) from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension).


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in MAS Score in the Gastrocnemius-soleus Complex (GSC) at the Ankle Joint of the (Most) Affected Lower Limb   [ Time Frame: Change from baseline to Week 4 ]
  Show Outcome Measure 1

2.  Secondary:   Physician’s Global Assessment (PGA) of the Treatment Response.   [ Time Frame: Week 4 ]
  Show Outcome Measure 2

3.  Secondary:   Goal Attainment Scale (GAS) Score   [ Time Frame: Week 4 ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
  Show 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



Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01249417     History of Changes
Other Study ID Numbers: Y-55-52120-141
2009-017709-12 ( EudraCT Number )
Study First Received: November 25, 2010
Results First Received: August 30, 2016
Last Updated: December 8, 2016