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Dysport® Adult Lower Limb Spasticity Follow-on Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01251367
First Posted: December 1, 2010
Last Update Posted: November 9, 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: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Post-stroke Spasticity
Spasticity Post-Traumatic Brain Injury
Intervention: Drug: Dysport®

  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 multicentre study and included 51 sites in Australia, Belgium, the Czech Republic, France, Hungary, Italy, Poland, Portugal, Russia, Slovakia and the United States of America that included at least one subject. The current study (Study 142) was an open label extension to the double blind Study 140 (Y-55-52120-140).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 366 subjects completed Study 140, of which 352 subjects were enrolled in Study 142. Of these, 7 subjects entered an observational phase and never received open label treatment with Dysport® in Study 142 and the remaining 345 subjects started treatment and received at least one open label injection of Dysport® in Study 142.

Reporting Groups
  Description
Total Dysport® Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 Units [U] or 1000 U) by intramuscular (i.m.) injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).

Participant Flow:   Overall Study
    Total Dysport®
STARTED   345 
Cycle 1   345 
Cycle 2   297 
Cycle 3   224 
Cycle 4   139 
COMPLETED   269 
NOT COMPLETED   76 
Protocol Violation                1 
Lack of Efficacy                2 
Adverse Event                19 
Withdrawal by Subject                36 
Lost to Follow-up                5 
Subject Required Alternative Treatment                7 
No Study Drug Available                1 
Subject had Personal or Medical Issues                4 
End of Study Visit Performed in Error                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.
The summary of baseline characteristics presented are from subjects completing Study 140 who were selected by the investigator for entry into Study 142 and received at least one injection of study treatment in this open label extension study.

Reporting Groups
  Description
Total Dysport® Subjects who had completed Study 140 were offered to continue to receive open label treatment with Dysport® in Study 142 for a maximum of 4 additional treatment cycles, with a minimum interval of 12 weeks between treatment cycles. All subjects were administered an appropriate dosage of Dysport® (1500 U or 1000 U) by i.m. injection in the lower limb on Day 1 of treatment Cycle 1. In all cases, the administration of the Dysport® injections was limited to a maximum dose of 1500 U every 12 weeks. Follow up visits were timed to assess the onset and progression of treatment response. From treatment Cycle 3 onwards, subjects with co-existing upper limb spasticity were able to receive concomitant injections of Dysport® into at least one upper limb muscle at a dose not exceeding 500 U. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).

Baseline Measures
   Total Dysport® 
Overall Participants Analyzed 
[Units: Participants]
 345 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      280  81.2% 
>=65 years      65  18.8% 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.1  (12.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      110  31.9% 
Male      235  68.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      34   9.9% 
Not Hispanic or Latino      311  90.1% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      7   2.0% 
Native Hawaiian or Other Pacific Islander      1   0.3% 
Black or African American      21   6.1% 
White      313  90.7% 
More than one race      3   0.9% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Assessment of the Long-Term Safety of Dysport® Through the Collection of Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: Up to EOS (maximum duration of 52 weeks). ]

2.  Primary:   Mean Change From Baseline to Week 4 in Systolic and Diastolic Blood Pressure (BP)   [ Time Frame: Baseline and Week 4 of each cycle ]

3.  Primary:   Mean Change From Baseline to Week 4 in Heart Rate (HR)   [ Time Frame: Baseline and Week 4 of each cycle ]

4.  Primary:   Mean Change From Baseline to Week 4 in Red Blood Cell (RBC) Count   [ Time Frame: Baseline and Week 4 of each cycle ]

5.  Primary:   Mean Change From Baseline to Week 4 in Haemoglobin and Mean Corpuscular Haemoglobin Concentration (MCHC)   [ Time Frame: Baseline and Week 4 of each cycle ]

6.  Primary:   Mean Change From Baseline to Week 4 in Haematocrit   [ Time Frame: Baseline and Week 4 of each cycle ]

7.  Primary:   Mean Change From Baseline to Week 4 in Mean Corpuscular Haemoglobin (MCH)   [ Time Frame: Baseline and Week 4 of each cycle ]

8.  Primary:   Mean Change From Baseline to Week 4 in Mean Corpuscular Volume (MCV)   [ Time Frame: Baseline and Week 4 of each cycle ]

9.  Primary:   Mean Change From Baseline to Week 4 in White Blood Cell (WBC) Count, Neutrophils, Lymphocytes and Platelets   [ Time Frame: Baseline and Week 4 of each cycle ]

10.  Primary:   Mean Change From Baseline to Week 4 in Alkaline Phosphatase (ALP), Gamma Glutamyl Transferase (GGT), Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)   [ Time Frame: Baseline and Week 4 of each cycle ]

11.  Primary:   Mean Change From Baseline to Week 4 in Total Bilirubin and Creatinine   [ Time Frame: Baseline and Week 4 of each cycle ]

12.  Primary:   Mean Change From Baseline to Week 4 in Blood Urea Nitrogen (BUN) and Fasting Blood Glucose   [ Time Frame: Baseline and Week 4 of each cycle ]

13.  Primary:   Presence of Botulinum Toxin Type A (BTX-A) Neutralising Putative Antibodies (NAbs) Following Injection of Dysport®   [ Time Frame: At Week 4 ]

14.  Primary:   Mean Change From Baseline to Week 4 in 12-Lead Electrocardiogram (ECG)   [ Time Frame: Baseline and Week 4 of each cycle ]

15.  Secondary:   Mean Change From Baseline to Week 4 in the Modified Ashworth Scale (MAS) Score Measured in the Gastrocnemius-soleus Complex (GSC) (Knee Extended)   [ Time Frame: Baseline and Week 4 of each cycle ]

16.  Secondary:   Mean Change From Baseline to Week 4 in the MAS Measured in the Soleus Muscle (Knee Flexed)   [ Time Frame: Baseline and Week 4 of each cycle ]

17.  Secondary:   Percentage of Subjects With At Least a 1 or 2 Grade Reduction in the MAS Measured in the GSC (Knee Extended) at Week 4   [ Time Frame: Week 4 of each cycle ]

18.  Secondary:   Percentage of Subjects With At Least a 1 or 2 Grade Reduction in the MAS Measured in the Soleus Muscle (Knee Flexed) at Week 4   [ Time Frame: Week 4 of each cycle ]

19.  Secondary:   Physician's Global Assessment (PGA) of Treatment Response at Week 4   [ Time Frame: Week 4 of each cycle ]

20.  Secondary:   Percentage of Subjects With a Score of at Least +1 on the PGA Scale at Week 4   [ Time Frame: Week 4 of each cycle ]

21.  Secondary:   Mean Change From Baseline to Week 4 in the Range of Active Ankle Dorsiflexion Both With the Knee Flexed and With the Knee Extended   [ Time Frame: Baseline and Week 4 of each cycle ]

22.  Secondary:   Mean Change From Baseline to Week 4 in Lower Limb Pain   [ Time Frame: Baseline and Week 4 of each cycle ]

23.  Secondary:   Mean Change From Baseline to Week 4 in Short Form (36) Health Survey (SF-36) Quality of Life (QoL)   [ Time Frame: Baseline and Week 4 of each cycle ]

24.  Secondary:   Mean Change From Baseline in European Quality of Life - 5 Dimensions, 5 Level (EQ-5D-5L) QoL   [ Time Frame: Baseline and Week 4 of each cycle ]

25.  Secondary:   Mean Change From Baseline to Week 4 in Walking Speed (WS)   [ Time Frame: Baseline and Week 4 of each cycle ]

26.  Secondary:   Mean Change From Baseline to Week 4 in Step Length   [ Time Frame: Baseline and Week 4 of each cycle ]

27.  Secondary:   Mean Change From Baseline to Week 4 in Cadence   [ Time Frame: Baseline and Week 4 of each cycle ]

28.  Secondary:   Mean Change From Baseline to Week 4 in Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X) in the GSC (Knee Extended)   [ Time Frame: Baseline and Week 4 of each cycle ]

29.  Secondary:   Mean Change From Baseline to Week 4 in Spasticity Grade (Y) in the GSC (Knee Extended)   [ Time Frame: Baseline and Week 4 of each cycle ]

30.  Secondary:   Mean Change From Baseline to Week 4 in Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X) in the Soleus Muscle (Knee Flexed)   [ Time Frame: Baseline and Week 4 of each cycle ]

31.  Secondary:   Mean Change From Baseline to Week 4 in Spasticity Grade (Y) in the Soleus Muscle (Knee Flexed)   [ Time Frame: Baseline and Week 4 of each cycle ]

32.  Secondary:   Use of Walking Aids/Orthoses at Baseline and Week 4   [ Time Frame: Baseline and Week 4 of each cycle ]


  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
Data is summarised according to total dose received at each corresponding cycle (i.e. including 1000 U and 1500 U Dysport® in lower limb during all cycles, as well as 1000 U in lower limb + 500 U Dysport® in upper limb during Cycles 3 and 4).


  More Information