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Dysport® Adult Lower Limb Spasticity Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01249404
First Posted: November 29, 2010
Last Update Posted: December 11, 2017
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.
Information provided by (Responsible Party):
Ipsen
Results First Submitted: July 3, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Leg Spasticity
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
The study was designed as a mutlicentre study and included 62 investigational centres in Australia, Belgium, the Czech Republic, France, Hungary, Italy, Poland, Portugal, Russia, Slovakia and the United States. Subjects were screened at 53 centres and in 52 centres subjects were randomised to receive study treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 456 subjects were screened, 388 were enrolled into the study and randomised to 1 of 3 treatment groups.

Reporting Groups
  Description
Dysport® 1000 U Subjects received intramuscular (i.m.) injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
Dysport® 1500 U Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
Placebo Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.

Participant Flow:   Overall Study
    Dysport® 1000 U   Dysport® 1500 U   Placebo
STARTED   127   129   132 
COMPLETED   120   121   125 
NOT COMPLETED   7   8   7 
Study treatment not received                0                1                2 
No MAS Score at baseline and/or Week 4                2                0                2 
Adverse Event                2                2                2 
Withdrawal by Subject                2                2                0 
Botulinum toxin (BTX) in upper limb                1                2                1 
Non compliance to visit schedule                0                1                0 



  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.
The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a Modified Ashworth Scale (MAS) score in the gastrocnemius-soleus (GSC) assessed at baseline (pre-treatment) and at Week 4.

Reporting Groups
  Description
Dysport® 1000 U Subjects received i.m.injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
Dysport® 1500 U Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
Placebo Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.
Total Title No text entered.

Baseline Measures
   Dysport® 1000 U   Dysport® 1500 U   Placebo   Total Title 
Overall Participants Analyzed 
[Units: Participants]
 125   128   128   381 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.2  (13.2)   53.3  (12.0)   51.4  (12.9)   52.6  (12.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      38  30.4%      49  38.3%      38  29.7%      125  32.8% 
Male      87  69.6%      79  61.7%      90  70.3%      256  67.2% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
Asian      3   2.4%      4   3.1%      3   2.3%      10   2.6% 
Black or African American      5   4.0%      13  10.2%      5   3.9%      23   6.0% 
Caucasian or White      116  92.8%      109  85.2%      119  93.0%      344  90.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      1   0.8%      0   0.0%      1   0.3% 
Multiple      1   0.8%      1   0.8%      1   0.8%      3   0.8% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      14  11.2%      11   8.6%      11   8.6%      36   9.4% 
Not Hispanic or Latino      111  88.8%      117  91.4%      117  91.4%      345  90.6% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Least Squares Mean Change From Baseline to Week 4 in the MAS Score in the Gastrocnemius-soleus Complex (GSC) (Knee Extended)   [ Time Frame: Baseline and Week 4 ]

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

3.  Secondary:   Least Squares Mean Change From Baseline to Week 4 in Comfortable Barefoot Walking Speed   [ Time Frame: Baseline and Week 4 ]

4.  Other Pre-specified:   Least Squares Mean Change From Baseline in MAS Score in the GSC (Knee Extended) at Weeks 1 and 12   [ Time Frame: Baseline and Weeks 1 and 12 ]

5.  Other Pre-specified:   Least Squares Mean Change From Baseline in MAS Score in the Soleus (Knee Flexed) at Weeks 1, 4 and 12   [ Time Frame: Baseline and Weeks 1, 4 and 12 ]

6.  Other Pre-specified:   PGA of Treatment Response at Week 12   [ Time Frame: At Week 12 ]

7.  Other Pre-specified:   Least Squares Mean Change From Baseline in Comfortable Barefoot Walking Speed at Weeks 1 and 12   [ Time Frame: Baseline and Weeks 1 and 12 ]

8.  Other Pre-specified:   Least Squares Mean Change From Baseline in Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12   [ Time Frame: Baseline and Weeks 1, 4 and 12 ]

9.  Other Pre-specified:   Least Squares Mean Change From Baseline in Maximal Barefoot Walking Speed at Weeks 1, 4 and 12   [ Time Frame: Baseline and Weeks 1, 4 and 12 ]

10.  Other Pre-specified:   Least Squares Mean Change From Baseline in Maximal Walking Speed With Shoes at Weeks 1, 4 and 12   [ Time Frame: Baseline and Weeks 1, 4 and 12 ]

11.  Other Pre-specified:   Least Squares Mean Change From Baseline in Cadence With Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12   [ Time Frame: Baseline and Weeks 1, 4 and 12 ]

12.  Other Pre-specified:   Least Squares Mean Change From Baseline in Average Step Length With Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12   [ Time Frame: Baseline and Weeks 1, 4 and 12 ]

13.  Other Pre-specified:   Least Squares Mean Change From Baseline in Cadence With Comfortable Barefoot Walking Speed at Weeks 1, 4 and 12   [ Time Frame: Baseline and Weeks 1, 4 and 12 ]

14.  Other Pre-specified:   Least Squares Mean Change From Baseline in Average Step Length With Comfortable Barefoot Walking Speed at Weeks 1, 4 and 12   [ Time Frame: Baseline and Weeks 1, 4 and 12 ]

15.  Other Pre-specified:   Least Squares Mean Change From Baseline in Cadence With Maximal Walking Speed With Shoes at Weeks 1, 4 and 12   [ Time Frame: Baseline and Weeks 1, 4 and 12 ]

16.  Other Pre-specified:   Least Squares Mean Change From Baseline in Average Step Length With Maximal Walking Speed With Shoes at Weeks 1, 4 and 12   [ Time Frame: Baseline and Weeks 1, 4 and 12 ]

17.  Other Pre-specified:   Least Squares Mean Change From Baseline in Cadence With Maximal Barefoot Walking Speed at Weeks 1, 4 and 12   [ Time Frame: Baseline and Weeks 1, 4 and 12 ]

18.  Other Pre-specified:   Least Squares Mean Change From Baseline in Average Step Length With Maximal Barefoot Walking Speed at Weeks 1, 4 and 12   [ Time Frame: Baseline and Weeks 1, 4 and 12 ]

19.  Other Pre-specified:   Least Squares Mean Change From Baseline in the Tardieu Scale in the GSC (Knee Extended) at Weeks 1, 4 and 12: Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X)   [ Time Frame: Baseline and Weeks 1, 4 and 12 ]

20.  Other Pre-specified:   Least Squares Mean Change From Baseline in the Tardieu Scale in the GSC (Knee Extended) at Weeks 1, 4 and 12: Spasticity Grade (Y)   [ Time Frame: Baseline and Weeks 1, 4 and 12 ]

21.  Other Pre-specified:   Least Squares Mean Change From Baseline in the Tardieu Scale in the Soleus (Knee Flexed) at Weeks 1, 4 and 12: Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X)   [ Time Frame: Baseline and Weeks 1, 4 and 12 ]

22.  Other Pre-specified:   Least Squares Mean Change From Baseline in the Tardieu Scale in the Soleus (Knee Flexed) at Weeks 1, 4 and 12: Spasticity Grade (Y)   [ Time Frame: Baseline and Weeks 1, 4 and 12 ]

23.  Other Pre-specified:   Least Squares Mean Change From Baseline in the Range of Active Dorsiflexion at Weeks 1, 4 and 12 (Knee Extended and Flexed)   [ Time Frame: Baseline and Weeks 1, 4 and 12 ]

24.  Other Pre-specified:   Least Squares Mean Change From Baseline in Lower Limb Pain at Weeks 1, 4 and 12   [ Time Frame: Baseline and Weeks 1, 4 and 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  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
e-mail: clinical.trials@ipsen.com



Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01249404     History of Changes
Other Study ID Numbers: Y-55-52120-140
2009-015868-34 ( EudraCT Number )
First Submitted: November 25, 2010
First Posted: November 29, 2010
Results First Submitted: July 3, 2017
Results First Posted: October 17, 2017
Last Update Posted: December 11, 2017