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Dysport® Adult Lower Limb Spasticity Follow-on Study

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ClinicalTrials.gov Identifier: NCT01251367
Recruitment Status : Completed
First Posted : December 1, 2010
Results First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Ipsen

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®
Enrollment 352

Recruitment Details 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 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.
Arm/Group Title Total Dysport®
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 345
Cycle 1 345
Cycle 2 297
Cycle 3 224
Cycle 4 139
Completed 269
Not Completed 76
Reason Not Completed
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
Arm/Group Title Total Dysport®
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 345
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 345 participants
<=18 years
0
   0.0%
Between 18 and 65 years
280
  81.2%
>=65 years
65
  18.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 345 participants
53.1  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 345 participants
Female
110
  31.9%
Male
235
  68.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 345 participants
Hispanic or Latino
34
   9.9%
Not Hispanic or Latino
311
  90.1%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 345 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%
1.Primary Outcome
Title Assessment of the Long-Term Safety of Dysport® Through the Collection of Treatment Emergent Adverse Events (TEAEs)
Hide Description Adverse events (AEs) were monitored from the time that the subject gave informed consent to the end of the study/early withdrawal (EOS/EW). An AE was reported as a TEAE if it was not present prior to study treatment administration in Study 140, or if it was present prior to study treatment in Study 140 but the intensity increased during the treatment phase of this study. Adverse events of special interest (AESIs) were identified as those assessed as being due to remote spread of effect of Dysport®, or any AE that was assessed as a hypersensitivity reaction. TEAEs, treatment related TEAEs, severe TEAEs, TEAEs leading to death, TEAEs leading to withdrawal, treatment emergent AESIs, and serious adverse events (SAEs) are summarised by treatment cycle.
Time Frame Up to EOS (maximum duration of 52 weeks).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Measure Type: Number
Unit of Measure: participants
TEAE - Cycle 1 Number Analyzed 345 participants
140
TEAE - Cycle 2 Number Analyzed 297 participants
97
TEAE - Cycle 3 Number Analyzed 224 participants
47
TEAE - Cycle 4 Number Analyzed 139 participants
21
Treatment Related TEAE - Cycle 1 Number Analyzed 345 participants
43
Treatment Related TEAE - Cycle 2 Number Analyzed 297 participants
23
Treatment Related TEAE - Cycle 3 Number Analyzed 224 participants
7
Treatment Related TEAE - Cycle 4 Number Analyzed 139 participants
5
Severe TEAE - Cycle 1 Number Analyzed 345 participants
13
Severe TEAE - Cycle 2 Number Analyzed 297 participants
9
Severe TEAE - Cycle 3 Number Analyzed 224 participants
4
Severe TEAE - Cycle 4 Number Analyzed 139 participants
2
TEAE leading to death - Cycle 1 Number Analyzed 345 participants
0
TEAE leading to death - Cycle 2 Number Analyzed 297 participants
1
TEAE leading to death - Cycle 3 Number Analyzed 224 participants
1
TEAE leading to death - Cycle 4 Number Analyzed 139 participants
0
TEAE leading to withdrawal - Cycle 1 Number Analyzed 345 participants
8
TEAE leading to withdrawal - Cycle 2 Number Analyzed 297 participants
10
TEAE leading to withdrawal - Cycle 3 Number Analyzed 224 participants
1
TEAE leading to withdrawal - Cycle 4 Number Analyzed 139 participants
0
AESI - Cycle 1 Number Analyzed 345 participants
31
AESI - Cycle 2 Number Analyzed 297 participants
24
AESI - Cycle 3 Number Analyzed 224 participants
10
AESI - Cycle 4 Number Analyzed 139 participants
5
SAE - Cycle 1 Number Analyzed 345 participants
23
SAE - Cycle 2 Number Analyzed 297 participants
14
SAE - Cycle 3 Number Analyzed 224 participants
7
SAE - Cycle 4 Number Analyzed 139 participants
2
2.Primary Outcome
Title Mean Change From Baseline to Week 4 in Systolic and Diastolic Blood Pressure (BP)
Hide Description Systolic and diastolic BP were recorded at baseline and at each subsequent study visit. BP was measured with the subject in a sitting position after resting for 3 minutes. Mean change in BP from baseline at Week 4 is reported per cycle.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Full Range)
Unit of Measure: Millimetres Mercury (mmHg)
Systolic BP - Cycle 1 Number Analyzed 331 participants
-0.7
(-67 to 37)
Systolic BP - Cycle 2 Number Analyzed 281 participants
-1.9
(-69 to 37)
Systolic BP - Cycle 3 Number Analyzed 200 participants
-2.4
(-58 to 79)
Systolic BP - Cycle 4 Number Analyzed 92 participants
-5.1
(-73 to 25)
Diastolic BP - Cycle 1 Number Analyzed 331 participants
0.3
(-34 to 37)
Diastolic BP - Cycle 2 Number Analyzed 281 participants
-0.2
(-38 to 30)
Diastolic BP - Cycle 3 Number Analyzed 200 participants
-0.3
(-32 to 28)
Diastolic BP - Cycle 4 Number Analyzed 92 participants
-1.1
(-35 to 32)
3.Primary Outcome
Title Mean Change From Baseline to Week 4 in Heart Rate (HR)
Hide Description HR was recorded at baseline and at each subsequent study visit. HR was measured with the subject in a sitting position after resting for 3 minutes. Mean change in HR from baseline at Week 4 is reported per cycle.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Full Range)
Unit of Measure: Beats per minute (bpm)
Cycle 1 Number Analyzed 331 participants
3.7
(-28 to 39)
Cycle 2 Number Analyzed 281 participants
4.9
(-27 to 41)
Cycle 3 Number Analyzed 200 participants
3.9
(-25 to 52)
Cycle 4 Number Analyzed 92 participants
4.5
(-16 to 33)
4.Primary Outcome
Title Mean Change From Baseline to Week 4 in Red Blood Cell (RBC) Count
Hide Description Blood samples for RBC count were taken at baseline, at Week 4, and at EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Full Range)
Unit of Measure: Tera cells/Litre (L)
Cycle 1 Number Analyzed 305 participants
0.049
(-0.51 to 0.66)
Cycle 2 Number Analyzed 260 participants
0.074
(-0.59 to 0.68)
Cycle 3 Number Analyzed 180 participants
0.046
(-0.59 to 0.66)
Cycle 4 Number Analyzed 78 participants
0.028
(-1.24 to 0.61)
5.Primary Outcome
Title Mean Change From Baseline to Week 4 in Haemoglobin and Mean Corpuscular Haemoglobin Concentration (MCHC)
Hide Description Blood samples for haemoglobin and MCHC were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Full Range)
Unit of Measure: grams (g)/L
Haemoglobin - Cycle 1 Number Analyzed 305 participants
1.2
(-17 to 32)
Haemoglobin - Cycle 2 Number Analyzed 260 participants
1.5
(-46 to 25)
Haemoglobin - Cycle 3 Number Analyzed 180 participants
1.5
(-22 to 26)
Haemoglobin - Cycle 4 Number Analyzed 78 participants
1.2
(-39 to 17)
MCHC - Cycle 1 Number Analyzed 305 participants
1.9
(-29 to 34)
MCHC - Cycle 2 Number Analyzed 260 participants
1.3
(-33 to 41)
MCHC - Cycle 3 Number Analyzed 180 participants
3.4
(-23 to 33)
MCHC - Cycle 4 Number Analyzed 78 participants
8.9
(-14 to 37)
6.Primary Outcome
Title Mean Change From Baseline to Week 4 in Haematocrit
Hide Description Blood samples for haematocrit were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Full Range)
Unit of Measure: percentage of RBC in blood
Cycle 1 Number Analyzed 305 participants
0.001
(-0.057 to 0.081)
Cycle 2 Number Analyzed 260 participants
0.003
(-0.107 to 0.098)
Cycle 3 Number Analyzed 180 participants
-0.001
(-0.066 to 0.086)
Cycle 4 Number Analyzed 78 participants
-0.009
(-0.12 to 0.047)
7.Primary Outcome
Title Mean Change From Baseline to Week 4 in Mean Corpuscular Haemoglobin (MCH)
Hide Description Blood samples for MCH were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Full Range)
Unit of Measure: picograms (pg)
Cycle 1 Number Analyzed 305 participants
-0.06
(-4.7 to 6.3)
Cycle 2 Number Analyzed 260 participants
-0.17
(-9.3 to 4.6)
Cycle 3 Number Analyzed 180 participants
0.00
(-2.8 to 5.3)
Cycle 4 Number Analyzed 78 participants
0.05
(-1.8 to 2)
8.Primary Outcome
Title Mean Change From Baseline to Week 4 in Mean Corpuscular Volume (MCV)
Hide Description Blood samples for MCV were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Full Range)
Unit of Measure: Femtolitres (fL)
Cycle 1 Number Analyzed 305 participants
-0.74
(-10.3 to 14.8)
Cycle 2 Number Analyzed 260 participants
-0.9
(-21.2 to 12.5)
Cycle 3 Number Analyzed 180 participants
-1.02
(-8.5 to 13.7)
Cycle 4 Number Analyzed 78 participants
-2.44
(-9.1 to 3.7)
9.Primary Outcome
Title Mean Change From Baseline to Week 4 in White Blood Cell (WBC) Count, Neutrophils, Lymphocytes and Platelets
Hide Description Blood samples for WBC count with differentials (neutrophils, lymphocytes) and platelet count were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Full Range)
Unit of Measure: Giga cells/L
WBC count - Cycle 1 Number Analyzed 305 participants
-0.21
(-8.7 to 5.3)
WBC count - Cycle 2 Number Analyzed 260 participants
-0.32
(-5.7 to 4.9)
WBC count - Cycle 3 Number Analyzed 180 participants
-0.26
(-5.2 to 5.1)
WBC count - Cycle 4 Number Analyzed 78 participants
-0.02
(-4.3 to 5.2)
Neutrophils - Cycle 1 Number Analyzed 304 participants
-0.17
(-7.5 to 4.5)
Neutrophils - Cycle 2 Number Analyzed 259 participants
-0.27
(-5.3 to 4.2)
Neutrophils - Cycle 3 Number Analyzed 179 participants
-0.28
(-5.6 to 4.8)
Neutrophils - Cycle 4 Number Analyzed 78 participants
-0.06
(-4.4 to 5.5)
Lymphocytes - Cycle 1 Number Analyzed 303 participants
-0.05
(-1.3 to 1.4)
Lymphocytes - Cycle 2 Number Analyzed 258 participants
-0.05
(-1.3 to 1.4)
Lymphocytes - Cycle 3 Number Analyzed 179 participants
0.03
(-1.2 to 2.5)
Lymphocytes - Cycle 4 Number Analyzed 78 participants
-0.01
(-0.9 to 2)
Platelets - Cycle 1 Number Analyzed 300 participants
-0.1
(-193 to 192)
Platelets - Cycle 2 Number Analyzed 257 participants
0.0
(-133 to 276)
Platelets - Cycle 3 Number Analyzed 178 participants
0.1
(-139 to 152)
Platelets - Cycle 4 Number Analyzed 77 participants
4.6
(-67 to 167)
10.Primary Outcome
Title 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)
Hide Description Blood samples were taken at baseline, at Week 4, and at the EOS/EW for analysis of the following clinical chemistry parameters: ALP, GGT, SGOT and SGPT. Outcome measure is reported per cycle as change from baseline at Week 4.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Full Range)
Unit of Measure: IU/L
ALP - Cycle 1 Number Analyzed 319 participants
-1.2
(-60 to 110)
ALP - Cycle 2 Number Analyzed 268 participants
-2.9
(-141 to 57)
ALP - Cycle 3 Number Analyzed 188 participants
-5.2
(-238 to 33)
ALP - Cycle 4 Number Analyzed 85 participants
-3.2
(-45 to 39)
SGOT - Cycle 1 Number Analyzed 319 participants
2.7
(-47 to 35)
SGOT - Cycle 2 Number Analyzed 268 participants
3
(-27 to 144)
SGOT - Cycle 3 Number Analyzed 188 participants
1.3
(-109 to 34)
SGOT - Cycle 4 Number Analyzed 85 participants
1.8
(-12 to 19)
SGPT - Cycle 1 Number Analyzed 319 participants
1.2
(-60 to 45)
SGPT - Cycle 2 Number Analyzed 268 participants
2.4
(-53 to 302)
SGPT - Cycle 3 Number Analyzed 188 participants
1.7
(-444 to 69)
SGPT - Cycle 4 Number Analyzed 85 participants
0.8
(-28 to 25)
GGT - Cycle 1 Number Analyzed 320 participants
1
(-122 to 614)
GGT - Cycle 2 Number Analyzed 268 participants
-1.9
(-145 to 121)
GGT - Cycle 3 Number Analyzed 188 participants
-3
(-254 to 107)
GGT - Cycle 4 Number Analyzed 85 participants
-0.4
(-61 to 70)
11.Primary Outcome
Title Mean Change From Baseline to Week 4 in Total Bilirubin and Creatinine
Hide Description Blood samples for clinical chemistry analysis of total bilirubin and creatinine were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Full Range)
Unit of Measure: Micromole/L (μmol/L)
Total bilirubin - Cycle 1 Number Analyzed 319 participants
0.13
(-13.7 to 12.8)
Total bilirubin - Cycle 2 Number Analyzed 268 participants
0.14
(-10.6 to 15.2)
Total bilirubin - Cycle 3 Number Analyzed 188 participants
0.03
(-10.4 to 7)
Total bilirubin - Cycle 4 Number Analyzed 85 participants
-0.05
(-9.1 to 16.1)
Creatinine - Cycle 1 Number Analyzed 320 participants
-2
(-36 to 27)
Creatinine - Cycle 2 Number Analyzed 268 participants
-5.3
(-36 to 35)
Creatinine - Cycle 3 Number Analyzed 188 participants
-7.9
(-53 to 35)
Creatinine - Cycle 4 Number Analyzed 85 participants
-14.2
(-62 to 9)
12.Primary Outcome
Title Mean Change From Baseline to Week 4 in Blood Urea Nitrogen (BUN) and Fasting Blood Glucose
Hide Description Blood samples for analysis of BUN and fasting blood glucose levels were taken at baseline, at Week 4 and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Full Range)
Unit of Measure: millimole/L (mmol/L)
BUN - Cycle 1 Number Analyzed 320 participants
0.14
(-3.93 to 5)
BUN - Cycle 2 Number Analyzed 268 participants
-0.05
(-3.57 to 5.72)
BUN - Cycle 3 Number Analyzed 188 participants
-0.19
(-11.06 to 4.29)
BUN - Cycle 4 Number Analyzed 85 participants
-0.37
(-4.64 to 3.57)
Fasting blood glucose - Cycle 1 Number Analyzed 169 participants
-0.046
(-6.16 to 6.38)
Fasting blood glucose - Cycle 2 Number Analyzed 143 participants
0.009
(-4.17 to 9.44)
Fasting blood glucose - Cycle 3 Number Analyzed 101 participants
0.015
(-5.66 to 7)
Fasting blood glucose - Cycle 4 Number Analyzed 55 participants
0.231
(-3.44 to 8.61)
13.Primary Outcome
Title Presence of Botulinum Toxin Type A (BTX-A) Neutralising Putative Antibodies (NAbs) Following Injection of Dysport®
Hide Description Blood samples were collected at baseline, Week 4 and at EOS/EW to test for the presence of BTX-A antibodies. The number of subjects who were either NAb positive at baseline or negative at baseline but then positive following injection of Dysport® were reported.
Time Frame At Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. In addition, the antibody analysis included subjects who had an antibody assessment at baseline and at a post baseline visit (n=343).
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Measure Type: Count of Participants
Unit of Measure: Participants
Positive at baseline Number Analyzed 343 participants
3
Negative at baseline & positive post baseline Number Analyzed 343 participants
0
14.Primary Outcome
Title Mean Change From Baseline to Week 4 in 12-Lead Electrocardiogram (ECG)
Hide Description 12-lead ECG tracing was performed at baseline, at Week 4 of each cycle and at EOS/EW. The 12-lead ECG recordings were performed at a paper speed of 25 millimetres/second (mm/s), recorded with the subject in a supine position after 5 minutes rest. The ECG parameters; QT Duration, QT interval corrected with Fridericia’s method (QTcF), QT interval corrected with Bazett’s method (QTcB), QRS duration and PR duration were recorded and outcome measure is reported per cycle as change from baseline at Week 4.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 324
Mean (Standard Deviation)
Unit of Measure: Milliseconds (ms)
QT Duration – Cycle 1 Number Analyzed 301 participants
-10.1  (24.9)
QT Duration – Cycle 2 Number Analyzed 260 participants
-12.2  (22.9)
QT Duration – Cycle 3 Number Analyzed 181 participants
-13.6  (26.5)
QT Duration – Cycle 4 Number Analyzed 83 participants
-16.5  (23.5)
QTcF – Cycle 1 Number Analyzed 301 participants
-0.6  (16.9)
QTcF – Cycle 2 Number Analyzed 260 participants
-1.9  (14.8)
QTcF – Cycle 3 Number Analyzed 181 participants
-3.8  (16.2)
QTcF – Cycle 4 Number Analyzed 83 participants
-1.8  (16.1)
QTcB – Cycle 1 Number Analyzed 301 participants
4.5  (20.2)
QTcB – Cycle 2 Number Analyzed 260 participants
3.5  (18.4)
QTcB – Cycle 3 Number Analyzed 181 participants
1.5  (19.5)
QTcB – Cycle 4 Number Analyzed 83 participants
6.1  (21.3)
QRS Duration – Cycle 1 Number Analyzed 301 participants
-0.6  (6.3)
QRS Duration – Cycle 2 Number Analyzed 260 participants
-0.7  (5.8)
QRS Duration – Cycle 3 Number Analyzed 181 participants
-0.8  (6.2)
QRS Duration – Cycle 4 Number Analyzed 83 participants
-0.9  (6.7)
PR Duration – Cycle 1 Number Analyzed 300 participants
-2.2  (14.5)
PR Duration – Cycle 2 Number Analyzed 259 participants
-1.7  (15.2)
PR Duration – Cycle 3 Number Analyzed 181 participants
-0.5  (14.4)
PR Duration – Cycle 4 Number Analyzed 83 participants
-0.6  (13.4)
15.Secondary Outcome
Title Mean Change From Baseline to Week 4 in the Modified Ashworth Scale (MAS) Score Measured in the Gastrocnemius-soleus Complex (GSC) (Knee Extended)
Hide Description Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. The MAS consists of 6 grades: 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)), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. Outcome measure is reported per cycle as mean change from baseline at Week 4.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Standard Deviation)
Unit of Measure: units on a scale
Cycle 1 Number Analyzed 341 participants
-0.8  (0.9)
Cycle 2 Number Analyzed 290 participants
-0.9  (1)
Cycle 3 Number Analyzed 218 participants
-1  (1)
Cycle 4 Number Analyzed 135 participants
-1  (0.9)
16.Secondary Outcome
Title Mean Change From Baseline to Week 4 in the MAS Measured in the Soleus Muscle (Knee Flexed)
Hide Description Muscle tone in the treated limb was assessed by MAS in the soleus muscle (with the knee flexed) at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. The MAS consists of 6 grades: 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 ROM), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. Outcome measure is reported per cycle as mean change from baseline at Week 4.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Standard Deviation)
Unit of Measure: units on a scale
Cycle 1 Number Analyzed 340 participants
-1  (1.2)
Cycle 2 Number Analyzed 290 participants
-1.1  (1)
Cycle 3 Number Analyzed 218 participants
-1.2  (1)
Cycle 4 Number Analyzed 135 participants
-1.1  (1.1)
17.Secondary Outcome
Title Percentage of Subjects With At Least a 1 or 2 Grade Reduction in the MAS Measured in the GSC (Knee Extended) at Week 4
Hide Description Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. The MAS consists of 6 grades: 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 ROM), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. Outcome measure is reported per cycle as the percentage of subjects with at least a 1 grade reduction or 2 grades reduction in MAS score at Week 4.
Time Frame Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Measure Type: Number
Unit of Measure: percentage of participants
At least 1 grade reduction - Cycle 1 Number Analyzed 345 participants
56.2
At least 1 grade reduction - Cycle 2 Number Analyzed 297 participants
57.6
At least 1 grade reduction - Cycle 3 Number Analyzed 224 participants
60.7
At least 1 grade reduction - Cycle 4 Number Analyzed 139 participants
66.9
At least 2 grades reduction - Cycle 1 Number Analyzed 345 participants
18.3
At least 2 grades reduction - Cycle 2 Number Analyzed 297 participants
23.2
At least 2 grades reduction - Cycle 3 Number Analyzed 224 participants
23.2
At least 2 grades reduction - Cycle 4 Number Analyzed 139 participants
22.3
18.Secondary Outcome
Title 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
Hide Description Muscle tone in the treated limb was assessed by MAS in the soleus muscle (with the knee flexed) at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. The MAS consists of 6 grades: 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 ROM), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. Outcome measure is reported per cycle as the percentage of subjects with at least a 1 grade reduction or 2 grades reduction in MAS score at Week 4.
Time Frame Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Measure Type: Number
Unit of Measure: percentage of participants
At least 1 grade reduction - Cycle 1 Number Analyzed 345 participants
61.4
At least 1 grade reduction - Cycle 2 Number Analyzed 297 participants
68.4
At least 1 grade reduction - Cycle 3 Number Analyzed 224 participants
72.3
At least 1 grade reduction - Cycle 4 Number Analyzed 139 participants
71.9
At least 2 grades reduction - Cycle 1 Number Analyzed 345 participants
28.4
At least 2 grades reduction - Cycle 2 Number Analyzed 297 participants
30.6
At least 2 grades reduction - Cycle 3 Number Analyzed 224 participants
30.4
At least 2 grades reduction - Cycle 4 Number Analyzed 139 participants
28.8
19.Secondary Outcome
Title Physician's Global Assessment (PGA) of Treatment Response at Week 4
Hide Description An assessment of overall treatment response was conducted by the investigator at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. The investigator rated the response to treatment in the subject’s lower limb after injection of Dysport® relative to the status at the baseline. Answers were made on a nine-point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. The mean PGA scores per cycle at Week 4 were reported.
Time Frame Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Standard Deviation)
Unit of Measure: units on a scale
Cycle 1 Number Analyzed 340 participants
1.4  (1.1)
Cycle 2 Number Analyzed 288 participants
1.6  (1)
Cycle 3 Number Analyzed 216 participants
1.8  (1)
Cycle 4 Number Analyzed 134 participants
1.9  (1)
20.Secondary Outcome
Title Percentage of Subjects With a Score of at Least +1 on the PGA Scale at Week 4
Hide Description An assessment of overall treatment response was conducted by the investigator at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. The investigator rated the response to treatment in the subject’s lower limb after injection of Dysport® relative to the status at the baseline. Answers were made on a nine point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. The percentage of responders with a PGA score of +1 or greater are reported at Week 4.
Time Frame Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Measure Type: Number
Unit of Measure: percentage of participants
Cycle 1 Number Analyzed 345 participants
83.8
Cycle 2 Number Analyzed 297 participants
86.2
Cycle 3 Number Analyzed 224 participants
89.3
Cycle 4 Number Analyzed 139 participants
89.9
21.Secondary Outcome
Title Mean Change From Baseline to Week 4 in the Range of Active Ankle Dorsiflexion Both With the Knee Flexed and With the Knee Extended
Hide Description Range of active dorsiflexion of the ankle joint of the treated limb, measured using a goniometre, both with the knee flexed (90°) and extended, was used to assess treatment response. The measurements were obtained at the end of baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. Outcome measure is reported per cycle as mean change from baseline at Week 4.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Standard Deviation)
Unit of Measure: Degrees
Knee Extended - Cycle 1 Number Analyzed 340 participants
4.1  (10.6)
Knee Extended - Cycle 2 Number Analyzed 290 participants
4.4  (10.6)
Knee Extended - Cycle 3 Number Analyzed 218 participants
6  (11.4)
Knee Extended - Cycle 4 Number Analyzed 135 participants
6.5  (10.9)
Knee Flexed - Cycle 1 Number Analyzed 341 participants
4.1  (10.7)
Knee Flexed - Cycle 2 Number Analyzed 290 participants
5  (10.3)
Knee Flexed - Cycle 3 Number Analyzed 218 participants
5.2  (10.9)
Knee Flexed - Cycle 4 Number Analyzed 135 participants
3.8  (9.8)
22.Secondary Outcome
Title Mean Change From Baseline to Week 4 in Lower Limb Pain
Hide Description The intensity of lower limb pain in the treated limb was evaluated by the subject using the Scale of Pain Intensity (SPIN) which provided a pictorial representation of pain in a 6-point graphic scale with the degree of red shading inside a circle representing the intensity of pain. The bottom and top of the scale are anchored by two extremes: ‘no pain’ (circle with no red shading and scored as 0) and ‘pain as bad as it could be’ (circle completely red and scored as 5), marked with either verbal or visual cues. The intervening points are represented by red circles increasing proportionally in size. The subject marks the circle that best indicates their pain intensity. The SPIN assessments were obtained at baseline, Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at the EOS/EW. The mean changes from baseline in subjects with a baseline SPIN Score >0 at Week 4 was reported per cycle.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Standard Deviation)
Unit of Measure: units on a scale
Cycle 1 Number Analyzed 189 participants
-0.7  (1.2)
Cycle 2 Number Analyzed 160 participants
-0.8  (1.2)
Cycle 3 Number Analyzed 118 participants
-0.9  (1.2)
Cycle 4 Number Analyzed 75 participants
-0.9  (1.2)
23.Secondary Outcome
Title Mean Change From Baseline to Week 4 in Short Form (36) Health Survey (SF-36) Quality of Life (QoL)
Hide Description Subjects were asked to complete the SF-36 health surveys prior to the study treatment at baseline, at Week 4 and at the EOS/EW visit. The SF-36 is a generic non preference based health status measure. This instrument assessed subject health across 8 variable dimensions, which are specific health domains such as physical functioning, social functioning and vitality. Each variable item score is coded and turned into a 0–100 scale where 0 indicates the worst and 100 indicates the best possible health state for both the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the questionnaire. The mean change in the PCS and MCS from baseline to Week 4 are reported.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Standard Deviation)
Unit of Measure: units on a scale
PCS - Cycle 1 Number Analyzed 330 participants
1.05  (7.5)
PCS - Cycle 2 Number Analyzed 287 participants
1.43  (7.67)
PCS - Cycle 3 Number Analyzed 213 participants
1.85  (7.01)
PCS - Cycle 4 Number Analyzed 134 participants
2.8  (6.65)
MCS - Cycle 1 Number Analyzed 330 participants
-1.13  (11.27)
MCS - Cycle 2 Number Analyzed 287 participants
-0.82  (12.7)
MCS - Cycle 3 Number Analyzed 213 participants
0.56  (12.24)
MCS - Cycle 4 Number Analyzed 134 participants
0.14  (13.23)
24.Secondary Outcome
Title Mean Change From Baseline in European Quality of Life - 5 Dimensions, 5 Level (EQ-5D-5L) QoL
Hide Description Subjects were asked to complete the EQ-5D-5L QoL questionnaire prior to the study treatment at baseline, at Week 4 and at EOS/EW visit. The EQ-5D-5L index is a generic preference based measure of health related QoL producing utility scores that represent subject preferences for particular health states. This instrument rated subject health state looking at 5 specific dimensions such as mobility, self-care, usual activity, pain/discomfort and anxiety/ depression and scored their general health state. Each dimension has 5 levels of severity: no problems, slight problems, moderate problems, severe problems and extreme problems, rated from 1 to 5 (best to worst). In addition, a visual analogue scale (VAS) ranging from 0 to 100 was also included for the patients to summarize their overall health status, where 0 is the worst and 100 the best possible health state. The mean change in pain and discomfort and VAS scores from baseline to Week 4 are reported.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pain/discomfort - Cycle 1 Number Analyzed 337 participants
-0.1  (1.0)
Pain/discomfort - Cycle 2 Number Analyzed 288 participants
-0.2  (1.0)
Pain/discomfort - Cycle 3 Number Analyzed 215 participants
-0.2  (1.0)
Pain/discomfort - Cycle 4 Number Analyzed 133 participants
-0.4  (1.2)
VAS - Cycle 1 Number Analyzed 336 participants
2.8  (18.3)
VAS - Cycle 2 Number Analyzed 286 participants
3.8  (17.7)
VAS - Cycle 3 Number Analyzed 215 participants
4.4  (19.9)
VAS - Cycle 4 Number Analyzed 133 participants
5.5  (21.0)
25.Secondary Outcome
Title Mean Change From Baseline to Week 4 in Walking Speed (WS)
Hide Description All WS tests were conducted without walking aids over a distance of 10 metres at both a comfortable WS and at maximal WS. Evaluations of WS were made barefoot and with shoes on, at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. Outcome measure is reported per cycle as mean change from baseline at Week 4.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Standard Deviation)
Unit of Measure: metres/second (m/s)
Comfortable WS, barefoot - Cycle 1 Number Analyzed 335 participants
0.07  (0.12)
Comfortable WS, barefoot - Cycle 2 Number Analyzed 285 participants
0.08  (0.13)
Comfortable WS, barefoot - Cycle 3 Number Analyzed 215 participants
0.08  (0.13)
Comfortable WS, barefoot - Cycle 4 Number Analyzed 134 participants
0.09  (0.14)
Comfortable WS, with shoes - Cycle 1 Number Analyzed 336 participants
0.06  (0.13)
Comfortable WS, with shoes - Cycle 2 Number Analyzed 289 participants
0.07  (0.14)
Comfortable WS, with shoes - Cycle 3 Number Analyzed 217 participants
0.08  (0.13)
Comfortable WS, with shoes - Cycle 4 Number Analyzed 134 participants
0.08  (0.14)
Maximal WS, barefoot - Cycle 1 Number Analyzed 336 participants
0.07  (0.16)
Maximal WS, barefoot - Cycle 2 Number Analyzed 286 participants
0.08  (0.18)
Maximal WS, barefoot - Cycle 3 Number Analyzed 215 participants
0.09  (0.18)
Maximal WS, barefoot - Cycle 4 Number Analyzed 134 participants
0.1  (0.18)
Maximal WS, with shoes - Cycle 1 Number Analyzed 335 participants
0.07  (0.17)
Maximal WS, with shoes - Cycle 2 Number Analyzed 286 participants
0.09  (0.19)
Maximal WS, with shoes - Cycle 3 Number Analyzed 217 participants
0.09  (0.19)
Maximal WS, with shoes - Cycle 4 Number Analyzed 134 participants
0.1  (0.21)
26.Secondary Outcome
Title Mean Change From Baseline to Week 4 in Step Length
Hide Description All WS tests were conducted without walking aids over a distance of 10 metres at both a comfortable WS and at maximal WS. Evaluations of step length were made barefoot and with shoes on, at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. Outcome measure is reported per cycle as mean change from baseline at Week 4.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Standard Deviation)
Unit of Measure: m/step
Comfortable WS, barefoot - Cycle 1 Number Analyzed 335 participants
0.03  (0.06)
Comfortable WS, barefoot - Cycle 2 Number Analyzed 285 participants
0.03  (0.09)
Comfortable WS, barefoot - Cycle 3 Number Analyzed 215 participants
0.03  (0.08)
Comfortable WS, barefoot - Cycle 4 Number Analyzed 134 participants
0.05  (0.09)
Comfortable WS, with shoes - Cycle 1 Number Analyzed 336 participants
0.03  (0.07)
Comfortable WS, with shoes - Cycle 2 Number Analyzed 289 participants
0.03  (0.08)
Comfortable WS, with shoes - Cycle 3 Number Analyzed 217 participants
0.03  (0.08)
Comfortable WS, with shoes - Cycle 4 Number Analyzed 134 participants
0.04  (0.09)
Maximal WS, barefoot - Cycle 1 Number Analyzed 336 participants
0.03  (0.08)
Maximal WS, barefoot - Cycle 2 Number Analyzed 286 participants
0.03  (0.09)
Maximal WS, barefoot - Cycle 3 Number Analyzed 215 participants
0.03  (0.09)
Maximal WS, barefoot - Cycle 4 Number Analyzed 134 participants
0.04  (0.09)
Maximal WS, with shoes - Cycle 1 Number Analyzed 335 participants
0.02  (0.08)
Maximal WS, with shoes - Cycle 2 Number Analyzed 286 participants
0.03  (0.09)
Maximal WS, with shoes - Cycle 3 Number Analyzed 217 participants
0.03  (0.09)
Maximal WS, with shoes - Cycle 4 Number Analyzed 134 participants
0.04  (0.1)
27.Secondary Outcome
Title Mean Change From Baseline to Week 4 in Cadence
Hide Description All WS tests were conducted without walking aids over a distance of 10 metres at both a comfortable WS and at maximal WS. Evaluations of cadence were made barefoot and with shoes on, at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. Outcome measure is reported per cycle as mean change from baseline at Week 4.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Standard Deviation)
Unit of Measure: steps/s
Comfortable WS, barefoot - Cycle 1 Number Analyzed 335 participants
0.08  (0.21)
Comfortable WS, barefoot - Cycle 2 Number Analyzed 285 participants
0.08  (0.23)
Comfortable WS, barefoot - Cycle 3 Number Analyzed 215 participants
0.08  (0.21)
Comfortable WS, barefoot - Cycle 4 Number Analyzed 134 participants
0.07  (0.21)
Comfortable WS, with shoes - Cycle 1 Number Analyzed 336 participants
0.07  (0.21)
Comfortable WS, with shoes - Cycle 2 Number Analyzed 289 participants
0.08  (0.22)
Comfortable WS, with shoes - Cycle 3 Number Analyzed 217 participants
0.08  (0.22)
Comfortable WS, with shoes - Cycle 4 Number Analyzed 134 participants
0.07  (0.21)
Maximal WS, barefoot - Cycle 1 Number Analyzed 336 participants
0.07  (0.26)
Maximal WS, barefoot - Cycle 2 Number Analyzed 286 participants
0.08  (0.28)
Maximal WS, barefoot - Cycle 3 Number Analyzed 215 participants
0.09  (0.26)
Maximal WS, barefoot - Cycle 4 Number Analyzed 134 participants
0.11  (0.25)
Maximal WS, with shoes - Cycle 1 Number Analyzed 335 participants
0.07  (0.23)
Maximal WS, with shoes - Cycle 2 Number Analyzed 286 participants
0.09  (0.27)
Maximal WS, with shoes - Cycle 3 Number Analyzed 217 participants
0.09  (0.27)
Maximal WS, with shoes - Cycle 4 Number Analyzed 134 participants
0.09  (0.27)
28.Secondary Outcome
Title 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)
Hide Description Spasticity in the treated limb was assessed using the Tardieu Scale (TS) for the GSC (knee extended). The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded at baseline, at Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported per cycle.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Standard Deviation)
Unit of Measure: Degrees
Angle of arrest (XV1) – Cycle 1 Number Analyzed 341 participants
2.7  (7.9)
Angle of arrest (XV1) – Cycle 2 Number Analyzed 290 participants
2.4  (7.8)
Angle of arrest (XV1) – Cycle 3 Number Analyzed 218 participants
2.6  (8.9)
Angle of arrest (XV1) – Cycle 4 Number Analyzed 135 participants
2.7  (8.4)
Angle of catch (XV3) – Cycle 1 Number Analyzed 341 participants
7.1  (10.6)
Angle of catch (XV3) – Cycle 2 Number Analyzed 289 participants
7.3  (11.1)
Angle of catch (XV3) – Cycle 3 Number Analyzed 218 participants
7.9  (12.2)
Angle of catch (XV3) – Cycle 4 Number Analyzed 135 participants
9.5  (12.4)
Spasticity angle (X) – Cycle 1 Number Analyzed 341 participants
-4.4  (8.6)
Spasticity angle (X) – Cycle 2 Number Analyzed 289 participants
-4.9  (9.2)
Spasticity angle (X) – Cycle 3 Number Analyzed 218 participants
-5.4  (9.3)
Spasticity angle (X) – Cycle 4 Number Analyzed 135 participants
-6.8  (9.2)
29.Secondary Outcome
Title Mean Change From Baseline to Week 4 in Spasticity Grade (Y) in the GSC (Knee Extended)
Hide Description Spasticity in the treated limb was assessed using the TS for the GSC (knee extended). The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Spasticity grade (Y) was recorded at baseline, at Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported per cycle.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Standard Deviation)
Unit of Measure: units on a scale
Cycle 1 Number Analyzed 341 participants
-0.5  (0.8)
Cycle 2 Number Analyzed 290 participants
-0.5  (0.7)
Cycle 3 Number Analyzed 218 participants
-0.5  (0.7)
Cycle 4 Number Analyzed 135 participants
-0.5  (0.8)
30.Secondary Outcome
Title 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)
Hide Description Spasticity in the treated limb was assessed using the TS for the soleus muscle (knee flexed). The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded at baseline, at Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported per cycle.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Standard Deviation)
Unit of Measure: Degrees
Angle of arrest (XV1) – Cycle 1 Number Analyzed 341 participants
1.9  (8.0)
Angle of arrest (XV1) – Cycle 2 Number Analyzed 290 participants
2.8  (8.1)
Angle of arrest (XV1) – Cycle 3 Number Analyzed 218 participants
2.6  (8.5)
Angle of arrest (XV1) – Cycle 4 Number Analyzed 135 participants
2.4  (8.6)
Angle of catch (XV3) – Cycle 1 Number Analyzed 341 participants
6.9  (10.3)
Angle of catch (XV3) – Cycle 2 Number Analyzed 289 participants
7.5  (10.8)
Angle of catch (XV3) – Cycle 3 Number Analyzed 218 participants
7.8  (11.2)
Angle of catch (XV3) – Cycle 4 Number Analyzed 135 participants
8.8  (11.4)
Spasticity angle (X) – Cycle 1 Number Analyzed 341 participants
-5.0  (10.0)
Spasticity angle (X) – Cycle 2 Number Analyzed 289 participants
-4.7  (9.8)
Spasticity angle (X) – Cycle 3 Number Analyzed 218 participants
-5.2  (9.6)
Spasticity angle (X) – Cycle 4 Number Analyzed 135 participants
-6.4  (11.1)
31.Secondary Outcome
Title Mean Change From Baseline to Week 4 in Spasticity Grade (Y) in the Soleus Muscle (Knee Flexed)
Hide Description Spasticity in the treated limb was assessed using the TS for the soleus muscle (knee flexed). The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Spasticity grade (Y) was recorded at baseline, at Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported per cycle.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Mean (Standard Deviation)
Unit of Measure: units on a scale
Cycle 1 Number Analyzed 341 participants
-0.6  (0.8)
Cycle 2 Number Analyzed 290 participants
-0.6  (0.7)
Cycle 3 Number Analyzed 218 participants
-0.7  (0.8)
Cycle 4 Number Analyzed 135 participants
-0.7  (0.7)
32.Secondary Outcome
Title Use of Walking Aids/Orthoses at Baseline and Week 4
Hide Description Subjects were assessed on their use of walking aids and orthoses at baseline, at Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at the EOS/EW visit. Outcome measure is reported per cycle at baseline and Week 4. Number of subjects with no walking aid/orthoses were included in the ‘No Walking Aid’ category and number of subjects with any kind of walking aid/orthosis (including single point cane, tripod cane, ankle foot orthosis or other type of walking aid/orthosis) were combined into the ‘Walking Aid’ category.
Time Frame Baseline and Week 4 of each cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 345
Measure Type: Count of Participants
Unit of Measure: Participants
No Walking Aid at Baseline - Cycle 1 Number Analyzed 345 participants
101
Walking Aid at Baseline - Cycle 1 Number Analyzed 345 participants
244
No Walking Aid at Week 4 - Cycle 1 Number Analyzed 341 participants
99
Walking Aid at Week 4 - Cycle 1 Number Analyzed 341 participants
242
No Walking Aid at Baseline - Cycle 2 Number Analyzed 297 participants
84
Walking Aid at Baseline - Cycle 2 Number Analyzed 297 participants
213
No Walking Aid at Week 4 - Cycle 2 Number Analyzed 292 participants
80
Walking Aid at Week 4 - Cycle 2 Number Analyzed 292 participants
212
No Walking Aid at Baseline - Cycle 3 Number Analyzed 224 participants
56
Walking Aid at Baseline - Cycle 3 Number Analyzed 224 participants
168
No Walking Aid at Week 4 - Cycle 3 Number Analyzed 206 participants
59
Walking Aid at Week 4 - Cycle 3 Number Analyzed 206 participants
147
No Walking Aid at Baseline - Cycle 4 Number Analyzed 139 participants
40
Walking Aid at Baseline - Cycle 4 Number Analyzed 139 participants
99
No Walking Aid at Week 4 - Cycle 4 Number Analyzed 97 participants
33
Walking Aid at Week 4 - Cycle 4 Number Analyzed 97 participants
64
Time Frame From baseline to EOS (maximum duration of 52 weeks).
Adverse Event Reporting Description AE data is reported as TEAEs. An AE was reported as a TEAE if it arose or the intensity increased during the treatment phase of this study.
 
Arm/Group Title Total Dysport®
Hide Arm/Group Description 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).
All-Cause Mortality
Total Dysport®
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Total Dysport®
Affected / at Risk (%) # Events
Total   43/345 (12.46%)    
Cardiac disorders   
Atrial fibrillation  1  1/345 (0.29%)  1
Coronary artery dissection  1  1/345 (0.29%)  1
Acute myocardial infarction  1  1/345 (0.29%)  1
Coronary artery disease  1  1/345 (0.29%)  1
Myocardial infarction  1  1/345 (0.29%)  1
Gastrointestinal disorders   
Dysphagia  1  2/345 (0.58%)  2
Dyspepsia  1  1/345 (0.29%)  1
Diarrhoea  1  1/345 (0.29%)  1
Intestinal polyp  1  1/345 (0.29%)  1
General disorders   
Asthenia  1  1/345 (0.29%)  1
Gait disturbance  1  2/345 (0.58%)  2
Chest pain  1  1/345 (0.29%)  1
Hepatobiliary disorders   
Cholecystitis  1  1/345 (0.29%)  1
Cholecystitis acute  1  1/345 (0.29%)  1
Infections and infestations   
Pneumonia  1  3/345 (0.87%)  3
Bronchitis  1  1/345 (0.29%)  1
Anal abscess  1  1/345 (0.29%)  1
Appendicitis  1  1/345 (0.29%)  1
Urinary tract infection  1  1/345 (0.29%)  1
Injury, poisoning and procedural complications   
Subdural haemorrhage  1  1/345 (0.29%)  1
Wrist fracture  1  1/345 (0.29%)  1
Concussion  1  1/345 (0.29%)  1
Head injury  1  1/345 (0.29%)  1
Fibula fracture  1  1/345 (0.29%)  1
Musculoskeletal and connective tissue disorders   
Intervertebral disc degeneration  1  1/345 (0.29%)  1
Muscular weakness  1  3/345 (0.87%)  3
Nervous system disorders   
Cerebral haemorrhage  1  2/345 (0.58%)  2
Presyncope  1  1/345 (0.29%)  1
Epilepsy  1  5/345 (1.45%)  5
Syncope  1  2/345 (0.58%)  2
Transient ischaemic attack  1  1/345 (0.29%)  1
Seizure  1  1/345 (0.29%)  1
Cerebrovascular accident  1  1/345 (0.29%)  1
Psychiatric disorders   
Completed suicide  1 [1]  1/345 (0.29%)  1
Anxiety  1  1/345 (0.29%)  1
Suicidal ideation  1  1/345 (0.29%)  1
Suicide attempt  1  1/345 (0.29%)  1
Respiratory, thoracic and mediastinal disorders   
Haemothorax  1  1/345 (0.29%)  1
Pulmonary embolism  1  1/345 (0.29%)  2
Pleural effusion  1  1/345 (0.29%)  1
Dyspnoea  1  1/345 (0.29%)  1
Respiratory failure  1 [1]  1/345 (0.29%)  1
Vascular disorders   
Venous thrombosis  1  1/345 (0.29%)  1
Haematoma  1  1/345 (0.29%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
[1]
Death
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Total Dysport®
Affected / at Risk (%) # Events
Total   69/345 (20.00%)    
Injury, poisoning and procedural complications   
Fall  1  42/345 (12.17%)  52
Musculoskeletal and connective tissue disorders   
Muscular weakness  1  36/345 (10.43%)  41
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
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).
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
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01251367     History of Changes
Other Study ID Numbers: Y-55-52120-142
First Submitted: November 25, 2010
First Posted: December 1, 2010
Results First Submitted: July 3, 2017
Results First Posted: November 9, 2017
Last Update Posted: November 9, 2017