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Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01357980
Recruitment Status : Completed
First Posted : May 23, 2011
Results First Posted : September 1, 2014
Last Update Posted : September 27, 2022
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Detrusor Muscle Hyperactivity
Interventions Biological: Botulinum toxin type A
Drug: Placebo
Enrollment 47
Recruitment Details Patients were recruited at 22 centres in six countries (Austria, the Czech Republic, Germany, France, Italy and Poland), including 17 centres in five countries (the Czech Republic, Germany, France, Italy and Poland) which enrolled patients.
Pre-assignment Details

A screening visit was performed four to seven days prior to Baseline (Day -7 to Day -4).

At Baseline, 47 subjects were randomised in a ratio of 5:2:5:2 to one of the four treatment groups.
Arm/Group Title Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
Hide Arm/Group Description Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose) Placebo: Intra detrusor injection on day 1 (single dose) Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose) Placebo: Intra detrusor injection on day 1 (single dose)
Period Title: Overall Study
Started 16 7 17 7
Completed 16 6 16 7
Not Completed 0 1 1 0
Reason Not Completed
Lack of Efficacy             0             1             0             0
Consent withdrawn             0             0             1             0
Arm/Group Title Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites) Total
Hide Arm/Group Description Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose) Placebo: Intra detrusor injection on day 1 (single dose) Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose) Placebo: Intra detrusor injection on day 1 (single dose) Total of all reporting groups
Overall Number of Baseline Participants 14 6 16 6 42
Hide Baseline Analysis Population Description
Demographic characteristics of the Intent to Treat (ITT) population: All randomised subjects who received at least one injection of study treatment and had an assessment for the averaged daily IEF both at Baseline and Day 84.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 6 participants 16 participants 6 participants 42 participants
41.1  (12.1) 46.5  (10.7) 50.5  (11.1) 40.8  (10.6) 47.9  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 6 participants 16 participants 6 participants 42 participants
Female
7
  50.0%
2
  33.3%
12
  75.0%
2
  33.3%
23
  54.8%
Male
7
  50.0%
4
  66.7%
4
  25.0%
4
  66.7%
19
  45.2%
Number of subjects with Spinal Cord Injury (SCI) or Multiple Sclerosis (MS)  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 14 participants 6 participants 16 participants 6 participants 42 participants
SCI 9 4 7 2 22
MS 5 2 9 4 20
Number of Subjects Using Anticholinergics  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 6 participants 16 participants 6 participants 42 participants
9 5 9 5 28
1.Primary Outcome
Title Daily Incontinence Episode Frequency (IEF)
Hide Description [Not Specified]
Time Frame Baseline and Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis based on number of subjects in the Intent to Treat (ITT) population.
Arm/Group Title Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
Hide Arm/Group Description:
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
Placebo: Intra detrusor injection on day 1 (single dose)
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
Placebo: Intra detrusor injection on day 1 (single dose)
Overall Number of Participants Analyzed 14 6 16 6
Mean (Standard Deviation)
Unit of Measure: episodes per day
Baseline 4.21  (2.32) 3.33  (2.87) 3.23  (1.26) 4.40  (1.55)
Change from baseline to Day 84 -3.51  (2.80) -1.05  (2.95) -2.86  (1.43) -3.40  (1.49)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (15 Injection Sites), Placebo (15 Injection Sites)
Comments Comparison of the average Daily IEF change from baseline to DAY 84 using ANCOVA with the baseline average daily IEF value as covariate.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments No multiplicity adjustment applied: each test conducted at a 5% significance level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value -1.54
Confidence Interval (2-Sided) 95%
-3.47 to 0.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (30 Injection Sites), Placebo (30 Injection Sites)
Comments Comparison of the average Daily IEF change from baseline to DAY 84 using ANCOVA with the baseline average daily IEF value as covariate.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments No multiplicity adjustment applied: each test conducted at a 5% significance level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-1.27 to 0.05
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Urodynamics: Maximum Cystometric Capacity
Hide Description Maximum Cystometric Capacity is an urodynamic parameter that indicates the volume at which a patient feels he (she) can no longer delay release of urine from the urinary bladder. Baseline urodynamics exams done at screening visit.
Time Frame Baseline, Days 14, 42 and 84
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis based on number (n) of subjects with a valid value in the Intent-to-Treat (ITT) population for the respective treatment groups.
Arm/Group Title Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
Hide Arm/Group Description:
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
Placebo: Intra detrusor injection on day 1 (single dose)
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
Placebo: Intra detrusor injection on day 1 (single dose)
Overall Number of Participants Analyzed 14 6 16 6
Mean (Standard Deviation)
Unit of Measure: mL
Baseline (n=14,5,16,6) 281  (186) 287  (112) 288  (144) 220  (55)
Change from baseline to D14 (n=14,5,16,6) 186  (160) -36  (140) 169  (92) -33  (88)
Change from baseline to D42 (n=14,6,15,6) 163  (208) 45  (64) 185  (174) 3  (94)
Change from baseline to D84 (n=14,5,16,6) 150  (174) 12.5  (26) 196  (135) 50  (145)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (15 Injection Sites), Placebo (15 Injection Sites)
Comments Comparison of the maximum Cystometric Capacity change from baseline to DAY 14 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value 219.5
Confidence Interval (2-Sided) 95%
69.6 to 369.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (30 Injection Sites), Placebo (30 Injection Sites)
Comments Comparison of the maximum Cystometric Capacity change from baseline to DAY 14 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value 224.1
Confidence Interval (2-Sided) 95%
140.9 to 307.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (15 Injection Sites), Placebo (15 Injection Sites)
Comments Comparison of the maximum Cystometric Capacity change from baseline to DAY 42 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value 117.0
Confidence Interval 95%
-20.0 to 254.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (30 Injection Sites), Placebo (30 Injection Sites)
Comments Comparison of the maximum Cystometric Capacity change from baseline to DAY 42 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value 223.7
Confidence Interval (2-Sided) 95%
94.3 to 353.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (15 Injection Sites), Placebo (15 Injection Sites)
Comments Comparison of the maximum Cystometric Capacity change from baseline to DAY 84 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value 138.5
Confidence Interval (2-Sided) 95%
34.7 to 242.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (30 Injection Sites), Placebo (30 Injection Sites)
Comments Comparison of the maximum Cystometric Capacity change from baseline to DAY 84 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value 186.3
Confidence Interval (2-Sided) 95%
53.2 to 319.4
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Urodynamics:Maximum Detrusor Pressure
Hide Description Maximum Detrusor Pressure is an urodynamic parameter that is the maximum value of the pressure within the bladder which is measured during the filling phase of the urodynamic exam. Baseline urodynamics exams done at screening visit.
Time Frame Baseline, Days 14, 42 and 84
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis based on number (n) of subjects with a valid value in the Intent-to-Treat (ITT) population for the respective treatment groups.
Arm/Group Title Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
Hide Arm/Group Description:
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
Placebo: Intra detrusor injection on day 1 (single dose)
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
Placebo: Intra detrusor injection on day 1 (single dose)
Overall Number of Participants Analyzed 14 6 16 6
Mean (Standard Deviation)
Unit of Measure: cm water (cm H20)
Baseline (n=14,5,15,6) 59  (44) 53  (40) 46  (28) 70  (23)
Change from baseline to D14 (n=14,5,16,6) -24  (53) -4  (18) -27  (22) 27  (48)
Change from baseline to D42 (n=14,6,15,6) -41  (40) -0.0  (14) -24  (24) 10  (42)
Change from baseline to D84 (n=13,5,16,6) -26  (46) 4  (18) -20  (23) 12  (29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (15 Injection Sites), Placebo (15 Injection Sites)
Comments Comparison of the maximum Detrusor Pressure change from baseline to DAY 14 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value -23.8
Confidence Interval (2-Sided) 95%
-66.6 to 18.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (30 Injection Sites), Placebo (30 Injection Sites)
Comments Comparison of the maximum Detrusor Pressure change from baseline to DAY 14 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value -67.1
Confidence Interval (2-Sided) 95%
-112.9 to -21.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (15 Injection Sites), Placebo (15 Injection Sites)
Comments Comparison of the maximum Detrusor Pressure change from baseline to DAY 42 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value -35.1
Confidence Interval (2-Sided) 95%
-65.6 to -4.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (30 Injection Sites), Placebo (30 Injection Sites)
Comments Comparison of the maximum Detrusor Pressure change from baseline to DAY 42 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value -51.0
Confidence Interval (2-Sided) 95%
-89.5 to -12.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (15 Injection Sites), Placebo (15 Injection Sites)
Comments Comparison of the maximum Detrusor Pressure change from baseline to DAY 84 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value -32.3
Confidence Interval (2-Sided) 95%
-53.7 to -11.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (30 Injection Sites), Placebo (30 Injection Sites)
Comments Comparison of the maximum Detrusor Pressure change from baseline to DAY 84 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value -45.3
Confidence Interval (2-Sided) 95%
-76.6 to -14.1
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Physician's Global Assessment Score of Treatment Response
Hide Description The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis based on number of subjects in the Intent to Treat (ITT) population.
Arm/Group Title Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
Hide Arm/Group Description:
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
Placebo: Intra detrusor injection on day 1 (single dose)
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
Placebo: Intra detrusor injection on day 1 (single dose)
Overall Number of Participants Analyzed 14 6 16 6
Measure Type: Number
Unit of Measure: participants
Markedly worse 0 0 0 0
Much worse 0 0 0 0
Worse 0 0 0 0
Slightly worse 1 1 0 1
No change 2 3 1 3
Slightly improved 0 0 0 0
Improved 3 1 4 2
Much improved 4 1 8 0
Markedly improved 4 0 3 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (15 Injection Sites), Placebo (15 Injection Sites)
Comments Comparison of the Physician's Global Assessment score at DAY 14 using a two sided Satterthwaite-Welch's t-test for independent samples.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Satterthwaite-Welch's t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value 1.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (30 Injection Sites), Placebo (30 Injection Sites)
Comments Comparison of the Physician's Global Assessment score at DAY 14 using a two sided Satterthwaite-Welch's t-test for independent samples.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Satterthwaite-Welch's t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value 2.3
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Physician's Global Assessment Score of Treatment Response
Hide Description The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis based on number of subjects in the Intent to Treat (ITT) population.
Arm/Group Title Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
Hide Arm/Group Description:
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
Placebo: Intra detrusor injection on day 1 (single dose)
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
Placebo: Intra detrusor injection on day 1 (single dose)
Overall Number of Participants Analyzed 14 6 16 6
Measure Type: Number
Unit of Measure: participants
Markedly worse 0 0 0 0
Much worse 0 0 0 0
Worse 0 0 0 0
Slightly worse 0 1 1 0
No change 1 3 0 3
Slightly improved 0 0 0 0
Improved 3 1 4 3
Much improved 5 1 7 0
Markedly improved 5 0 4 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (15 Injection Sites), Placebo (15 Injection Sites)
Comments Comparison of the Physician's Global Assessment score at DAY 42 using a two sided Satterthwaite-Welch's t-test for independent samples.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Satterthwaite-Welch's t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value 2.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (30 Injection Sites), Placebo (30 Injection Sites)
Comments Comparison of the Physician's Global Assessment score at DAY 42 using a two sided Satterthwaite-Welch's t-test for independent samples.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Satterthwaite-Welch's t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value 1.8
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Physician's Global Assessment Score of Treatment Response
Hide Description The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis based on number of subjects in the Intent to Treat (ITT) population.
Arm/Group Title Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
Hide Arm/Group Description:
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
Placebo: Intra detrusor injection on day 1 (single dose)
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
Placebo: Intra detrusor injection on day 1 (single dose)
Overall Number of Participants Analyzed 14 6 16 6
Measure Type: Number
Unit of Measure: participants
Markedly worse 0 0 0 0
Much worse 0 0 0 0
Worse 0 1 0 0
Slightly worse 0 0 0 0
No change 1 2 1 4
Slightly improved 2 1 0 0
Improved 2 1 4 2
Much improved 6 1 7 0
Markedly improved 3 0 4 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (15 Injection Sites), Placebo (15 Injection Sites)
Comments Comparison of the Physician's Global Assessment score at DAY 84 using a two sided Satterthwaite-Welch's t-test for independent samples.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Satterthwaite-Welch's t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value 1.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (30 Injection Sites), Placebo (30 Injection Sites)
Comments Comparison of the Physician's Global Assessment score at DAY 84 using a two sided Satterthwaite-Welch's t-test for independent samples.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Satterthwaite-Welch's t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value 2.1
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Quality of Life (QoL) Total Summary Score
Hide Description

Mean Change from Baseline in Short Form (SF)-Qualiveen Questionnaire Calculated Total Score.

The SF-Qualiveen questionnaire is a specific health related QoL questionnaire validated for urinary disorders in subjects with neurological conditions containing 8 items looking at four scales: limitations (2 items); constraints (2 items); fears (2 items) and feelings (2 items). The 8 items each having a 5-point Likert-type scale ranging from 0="Not at all" to 4="Extremely" for the first 6 items, from 0="Never" to 4="Always" for item 7 and from 0="Always" to 4="Never" for item 8. The score per scale has been calculated as the mean of the two items. In case of one missing item among the 2 items for a given scale, the score has not been calculated.

Total score has been calculated as the mean of all the items completed among the 8 items.

Lower scores indicate a better QoL (i.e. no limitations, fears, constraints, or negative feelings) and higher scores indicate poorer QoL.
Time Frame Baseline, 14, 42 and 84
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis based on number of subjects in the Intent to Treat (ITT) population.
Arm/Group Title Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
Hide Arm/Group Description:
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
Placebo: Intra detrusor injection on day 1 (single dose)
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
Placebo: Intra detrusor injection on day 1 (single dose)
Overall Number of Participants Analyzed 14 6 16 6
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 2.4  (0.7) 2.7  (0.6) 2.4  (0.8) 2.3  (1.0)
Change from baseline to D14 -1.1  (0.9) -0.2  (1.0) -0.8  (0.8) -0.5  (1.3)
Change from baseline to D42 -1.0  (0.8) -0.6  (1.2) -1.2  (0.8) -0.6  (1.1)
Change from baseline to D84 -1.3  (1.0) -0.2  (0.7) -1.2  (0.9) -0.7  (1.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (15 Injection Sites), Placebo (15 Injection Sites)
Comments Comparison of the Quality of Life Total Summary score change from baseline to DAY 14 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value -1.13
Confidence Interval (2-Sided) 95%
-1.91 to -0.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (30 Injection Sites), Placebo (30 Injection Sites)
Comments Comparison of the Quality of Life Total Summary score change from baseline to DAY 14 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-1.26 to 0.90
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (15 Injection Sites), Placebo (15 Injection Sites)
Comments Comparison of the Quality of Life Total Summary score change from baseline to DAY 42 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value -0.52
Confidence Interval (2-Sided) 95%
-1.56 to 0.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (30 Injection Sites), Placebo (30 Injection Sites)
Comments Comparison of the Quality of Life Total Summary score change from baseline to DAY 42 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value -0.48
Confidence Interval (2-Sided) 95%
-1.47 to 0.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (15 Injection Sites), Placebo (15 Injection Sites)
Comments Comparison of the Quality of Life Total Summary score change from baseline to DAY 84 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value -1.38
Confidence Interval (2-Sided) 95%
-2.02 to -0.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Dysport 750 U (30 Injection Sites), Placebo (30 Injection Sites)
Comments Comparison of the Quality of Life Total Summary score change from baseline to DAY 84 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Treatment Difference
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-1.35 to 0.55
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection
Hide Description Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis based on number of subjects in the Safety population with a valid value.
Arm/Group Title Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
Hide Arm/Group Description:
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
Placebo: Intra detrusor injection on day 1 (single dose)
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
Placebo: Intra detrusor injection on day 1 (single dose)
Overall Number of Participants Analyzed 14 6 15 6
Mean (Standard Deviation)
Unit of Measure: mm
2.7  (9.0) 12.2  (21.5) 1.3  (2.6) 6.7  (16.3)
9.Secondary Outcome
Title Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure
Hide Description Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis based on number of subjects in the Safety population with a valid value.
Arm/Group Title Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
Hide Arm/Group Description:
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
Placebo: Intra detrusor injection on day 1 (single dose)
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
Placebo: Intra detrusor injection on day 1 (single dose)
Overall Number of Participants Analyzed 14 6 14 6
Mean (Standard Deviation)
Unit of Measure: mm
13.7  (19.3) 11.0  (19.9) 15.8  (19.7) 10.0  (24.5)
Time Frame 98 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
Hide Arm/Group Description Botulinum type A toxin (Dysport®): 750 U using different administration regimen, intra detrusor injection on day 1 (single dose) Placebo: Intra detrusor injection on day 1 (single dose) Botulinum type A toxin (Dysport®): 750 U using different administration regimen, intra detrusor injection on day 1 (single dose) Placebo: Intra detrusor injection on day 1 (single dose)
All-Cause Mortality
Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/16 (31.25%)      0/7 (0.00%)      1/17 (5.88%)      0/7 (0.00%)    
Infections and infestations         
Urinary tract infection † 1  1/16 (6.25%)  1 0/7 (0.00%)  0 0/17 (0.00%)  0 0/7 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Muscular weakness † 1  3/16 (18.75%)  3 0/7 (0.00%)  0 0/17 (0.00%)  0 0/7 (0.00%)  0
Nervous system disorders         
Multiple sclerosis relapse † 1  1/16 (6.25%)  1 0/7 (0.00%)  0 0/17 (0.00%)  0 0/7 (0.00%)  0
Psychiatric disorders         
Depression † 1  0/16 (0.00%)  0 0/7 (0.00%)  0 1/17 (5.88%)  1 0/7 (0.00%)  0
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version: 15.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/16 (43.75%)      3/7 (42.86%)      11/17 (64.71%)      4/7 (57.14%)    
Gastrointestinal disorders         
Diarrhoea † 1  1/16 (6.25%)  1 0/7 (0.00%)  0 0/17 (0.00%)  0 0/7 (0.00%)  0
General disorders         
Asthenia † 1  0/16 (0.00%)  0 0/7 (0.00%)  0 2/17 (11.76%)  2 2/7 (28.57%)  2
Influenza like illness † 1  0/16 (0.00%)  0 0/7 (0.00%)  0 1/17 (5.88%)  1 0/7 (0.00%)  0
Infections and infestations         
Acute tonsillitis † 1  0/16 (0.00%)  0 0/7 (0.00%)  0 1/17 (5.88%)  1 0/7 (0.00%)  0
Bacteriuria † 1  1/16 (6.25%)  1 0/7 (0.00%)  0 0/17 (0.00%)  0 0/7 (0.00%)  0
Escherichia sepsis † 1  1/16 (6.25%)  1 0/7 (0.00%)  0 0/17 (0.00%)  0 0/7 (0.00%)  0
Fungal infection † 1  0/16 (0.00%)  0 0/7 (0.00%)  0 1/17 (5.88%)  1 0/7 (0.00%)  0
Gastroenteritis † 1  1/16 (6.25%)  1 0/7 (0.00%)  0 0/17 (0.00%)  0 0/7 (0.00%)  0
Urinary tract infection † 1  1/16 (6.25%)  1 0/7 (0.00%)  0 3/17 (17.65%)  3 1/7 (14.29%)  1
Injury, poisoning and procedural complications         
Fall † 1  0/16 (0.00%)  0 0/7 (0.00%)  0 1/17 (5.88%)  1 0/7 (0.00%)  0
Investigations         
Blood urine present † 1  0/16 (0.00%)  0 0/7 (0.00%)  0 0/17 (0.00%)  0 1/7 (14.29%)  1
Gamma-glutamyltransferase increased † 1  0/16 (0.00%)  0 0/7 (0.00%)  0 1/17 (5.88%)  1 0/7 (0.00%)  0
Neutrophil count increased † 1  1/16 (6.25%)  1 0/7 (0.00%)  0 0/17 (0.00%)  0 0/7 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain † 1  1/16 (6.25%)  1 0/7 (0.00%)  0 0/17 (0.00%)  0 0/7 (0.00%)  0
Muscular weakness † 1  0/16 (0.00%)  0 0/7 (0.00%)  0 1/17 (5.88%)  1 0/7 (0.00%)  0
Renal and urinary disorders         
Bladder Pain † 1  0/16 (0.00%)  0 1/7 (14.29%)  1 0/17 (0.00%)  0 0/7 (0.00%)  0
Haematuria † 1  0/16 (0.00%)  0 1/7 (14.29%)  1 0/17 (0.00%)  0 0/7 (0.00%)  0
Vascular disorders         
Hypertension † 1  0/16 (0.00%)  0 1/7 (14.29%)  1 0/17 (0.00%)  0 0/7 (0.00%)  0
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version: 15.1
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Medical Director Neurology
Organization: Ipsen
Phone: clinical.trials@ipsen.com
EMail: clinical.trials@ipsen.com
Publications:
Layout table for additonal information
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01357980    
Other Study ID Numbers: Y-52-52120-155
2010-023210-31 ( EudraCT Number )
First Submitted: May 17, 2011
First Posted: May 23, 2011
Results First Submitted: March 27, 2014
Results First Posted: September 1, 2014
Last Update Posted: September 27, 2022