Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia

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: NCT00257660
Recruitment Status : Completed
First Posted : November 23, 2005
Results First Posted : May 10, 2010
Last Update Posted : February 8, 2019
Sponsor:
Information provided by:
Ipsen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Cervical Dystonia
Interventions Drug: Botulinum type A toxin (Dysport®)
Drug: Placebo
Enrollment 116
Recruitment Details Patients were recruited at 16 centres in the USA and 4 centres in Russia from October 2005 until September 2006
Pre-assignment Details  
Arm/Group Title Dysport 500 Units Placebo
Hide Arm/Group Description Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Period Title: Overall Study
Started 55 61
Completed 45 38
Not Completed 10 23
Reason Not Completed
Lack of Efficacy             5             23
Withdrawal by Subject             2             0
Lost to Follow-up             1             0
PI & Subject Schedule Conflicts             1             0
No longer wanted to do blood draws             1             0
Arm/Group Title Dysport 500 Units Placebo Total
Hide Arm/Group Description Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible Total of all reporting groups
Overall Number of Baseline Participants 55 61 116
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 61 participants 116 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
46
  83.6%
50
  82.0%
96
  82.8%
>=65 years
9
  16.4%
11
  18.0%
20
  17.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 61 participants 116 participants
51.9  (13.4) 53.9  (12.5) 53.0  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 61 participants 116 participants
Female
37
  67.3%
38
  62.3%
75
  64.7%
Male
18
  32.7%
23
  37.7%
41
  35.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 55 participants 61 participants 116 participants
United States 41 47 88
Russian Federation 14 14 28
1.Primary Outcome
Title Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Hide Description TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 4 subjects for Dysport and 3 for placebo who were not assessed on TWSTRS score at Week 4. As there was no imputation of missing TWSTRS score values, these 7 subjects were not taken into account.
Arm/Group Title Dysport 500 Units Placebo
Hide Arm/Group Description:
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Overall Number of Participants Analyzed 51 58
Mean (Standard Deviation)
Unit of Measure: points on a scale
Change in TWSTRS total score -13.99  (12.33) -5.23  (9.33)
Baseline TWSTRS total score 43.83  (7.97) 45.81  (8.78)
Week 4 TWSTRS total score 30.04  (12.65) 40.22  (11.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport 500 Units, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.
Method ANCOVA
Comments Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -8.84
Confidence Interval (2-Sided) 95%
-12.94 to -4.74
Estimation Comments

Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the analysis at Week 4 excludes the scores for the 7 subjects who were not assessed.

Mean difference = difference in adjusted least squares mean (Dysport - Placebo).

2.Secondary Outcome
Title Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Hide Description TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 9 subjects for Dysport and 15 for placebo who were not assessed on TWSTRS score at Week 8. As there was no imputation of missing TWSTRS score values, these 24 subjects were not taken into account.
Arm/Group Title Dysport 500 Units Placebo
Hide Arm/Group Description:
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Overall Number of Participants Analyzed 46 46
Mean (Standard Deviation)
Unit of Measure: points on a scale
Change in TWSTRS total score -13.82  (11.53) -5.59  (11.37)
Baseline TWSTRS total score 43.83  (7.97) 45.81  (8.78)
Week 8 TWSTRS total score 29.31  (10.99) 39.64  (13.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport 500 Units, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.
Method ANCOVA
Comments Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -8.81
Confidence Interval 95%
-12.91 to -4.71
Estimation Comments

Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the Week 8 analysis excludes the scores for the 24 subjects who were not assessed.

Mean difference = difference in adjusted least squares mean (Dysport - Placebo).

3.Secondary Outcome
Title Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
Hide Description TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 10 subjects for Dysport and 17 for placebo who were not assessed on TWSTRS score at Week 12. As there was no imputation of missing TWSTRS score values, these 27 subjects were not taken into account.
Arm/Group Title Dysport 500 Units Placebo
Hide Arm/Group Description:
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Overall Number of Participants Analyzed 45 44
Mean (Standard Deviation)
Unit of Measure: points on a scale
Change in TWSTRS total score -6.98  (11.12) -4.53  (7.75)
Baseline TWSTRS total score 43.83  (7.97) 45.81  (8.78)
Week 12 TWSTRS total score 36.04  (11.76) 40.76  (11.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport 500 Units, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.
Method ANCOVA
Comments Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.12
Confidence Interval 95%
-7.55 to -0.68
Estimation Comments

Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the Week 12 analysis excludes the scores for the 27 subjects who were not assessed.

Mean difference = difference in adjusted least squares mean (Dysport - Placebo).

4.Secondary Outcome
Title Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment
Hide Description The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. There were 5 subjects on Dysport and 8 on placebo who were not assessed on the change in subject VAS score for CD symptoms at Week 4. There was no imputation of missing VAS scores, so these 13 subjects were not taken into account.
Arm/Group Title Dysport 500 Units Placebo
Hide Arm/Group Description:
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Overall Number of Participants Analyzed 50 53
Mean (Standard Deviation)
Unit of Measure: points on a scale
Change in Subject VAS for CD symptoms -24.2  (29.5) -6.7  (20.8)
Baseline Subject VAS for CD symptoms 67.7  (19.7) 63.6  (18.9)
Week 4 Subject VAS for CD symptoms 44.3  (24.4) 55.7  (20.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport 500 Units, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.
Method ANCOVA
Comments Treatment group, baseline Subject VAS symptom score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -15.2
Confidence Interval 95%
-24.0 to -6.4
Estimation Comments Analysis at baseline (and on change at Week 4) excludes 4 subjects (and 13 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)
5.Secondary Outcome
Title Investigator VAS for CD Symptom Assessment
Hide Description The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 3 subjects for Dysport and 5 for placebo who were not assessed on the change in investigator VAS score at Week 4. As there was no imputation of missing VAS scores, these 8 subjects were not taken into account.
Arm/Group Title Dysport 500 Units Placebo
Hide Arm/Group Description:
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Overall Number of Participants Analyzed 52 56
Mean (Standard Deviation)
Unit of Measure: points on a scale
Change in Investigator VAS for CD symptoms -23.1  (22.1) -9.1  (20.2)
Baseline Investigator VAS for CD symptoms 62.3  (15.8) 65.3  (18.0)
Week 4 Investigator VAS for CD symptoms 40.3  (21.7) 56.8  (21.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport 500 Units, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.
Method ANCOVA
Comments Treatment group, baseline Investigator VAS CD symptom score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -14.2
Confidence Interval 95%
-22.3 to -6.1
Estimation Comments Analysis at baseline (and on change at Week 4) excludes 3 subjects (and 8 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)
6.Secondary Outcome
Title Subject VAS for CD Symptom Assessment
Hide Description The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100mm (worst possible symptoms).
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 8 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 4 patients on placebo with missing baseline and Week 4 values.
Arm/Group Title Dysport 500 Units Placebo
Hide Arm/Group Description:
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Overall Number of Participants Analyzed 55 57
Mean (Standard Deviation)
Unit of Measure: points on a scale
Change in subject VAS for CD symptoms -24.6  (30.0) -5.4  (25.4)
Baseline subject VAS for CD symptoms 67.7  (19.7) 63.6  (18.9)
Week 8 subject VAS for CD symptoms 44.7  (24.9) 57.8  (27.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport 500 Units, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.
Method ANCOVA
Comments Treatment group, baseline Subject VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -16.95
Confidence Interval 95%
-25.8 to -8.1
Estimation Comments Analysis at baseline (and on change at Week 8) excludes 4 subjects (and 4 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)
7.Secondary Outcome
Title Investigator's VAS for CD Symptom Assessment
Hide Description The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Time Frame Baseline and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 8 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 3 patients with missing baseline and Week 4 values.
Arm/Group Title Dysport 500 Units Placebo
Hide Arm/Group Description:
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Overall Number of Participants Analyzed 54 59
Mean (Standard Deviation)
Unit of Measure: points on a scale
Change in Investigator VAS for CD symptoms -20.5  (22.7) -5.0  (21.3)
Baseline Investigator VAS for CD symptoms 62.3  (15.8) 65.3  (18.0)
Week 8 Investigator VAS for CD symptoms 40.8  (22.3) 60.8  (24.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport 500 Units, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.
Method ANCOVA
Comments Treatment group, baseline Investigator VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -16.0
Confidence Interval 95%
-24.2 to -7.8
Estimation Comments Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 3 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)
8.Secondary Outcome
Title Subject VAS for CD Symptom Assessment
Hide Description The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 12 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 4 patients on placebo with missing baseline, Week 4 and Week 8 values.
Arm/Group Title Dysport 500 Units Placebo
Hide Arm/Group Description:
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Overall Number of Participants Analyzed 55 57
Mean (Standard Deviation)
Unit of Measure: points on a scale
Change in subject VAS for CD symptoms -14.4  (25.2) -4.6  (23.3)
Baseline subject VAS for CD symptoms 67.7  (19.7) 63.6  (18.9)
Week 12 subject VAS for CD symptoms 55.4  (25.5) 58.2  (25.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport 500 Units, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.
Method ANCOVA
Comments Treatment group, baseline Subject VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -11.05
Confidence Interval 95%
-19.0 to -3.1
Estimation Comments Analysis at baseline (and on change at Week 12) excludes 4 subjects (and 4 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)
9.Secondary Outcome
Title Investigator's VAS for CD Symptom Assessment
Hide Description The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms) to 100 mm (worst possible symptoms).
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 12 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 3 patients with missing baseline, Week 4 and Week 8 values.
Arm/Group Title Dysport 500 Units Placebo
Hide Arm/Group Description:
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Overall Number of Participants Analyzed 54 59
Mean (Standard Deviation)
Unit of Measure: points on a scale
Change in Investigator VAS for CD symptoms -8.5  (18.9) -5.8  (15.8)
Baseline Investigator VAS for CD symptoms 62.3  (15.8) 65.3  (18.0)
Week 12 Investigator VAS for CD symptoms 54.8  (20.8) 60.0  (21.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport 500 Units, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.
Method ANCOVA
Comments Treatment group, baseline Investigator VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -7.05
Confidence Interval 95%
-13.3 to -0.8
Estimation Comments Analysis at baseline (and on change at Week 12) excludes 3 subjects (and 3 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)
10.Secondary Outcome
Title SF-36 Mental Health Summary Score
Hide Description SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Mental Health Summary Score is derived from four individual domains (vitality, social functioning, role limitations due to emotional problems and mental health).
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. There were 13 subjects on Dysport and 24 on placebo who were not assessed on the change in mental health summary at Week 8. There was no imputation of missing scores, so these 37 subjects were not taken into account.
Arm/Group Title Dysport 500 Units Placebo
Hide Arm/Group Description:
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Overall Number of Participants Analyzed 42 37
Mean (Standard Deviation)
Unit of Measure: points on a scale
Change in SF-36 Mental health summary Score 4.11  (9.18) 2.48  (8.12)
Baseline SF-36 Mental health summary Score 44.52  (10.41) 43.31  (11.14)
Week 8 SF-36 Mental health summary Score 49.00  (8.69) 43.41  (12.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport 500 Units, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.061
Comments A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.
Method ANCOVA
Comments Treatment group, baseline SF-36 mental health summary score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.65
Confidence Interval 95%
-0.17 to 7.47
Estimation Comments Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 37 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)
11.Secondary Outcome
Title SF-36 Physical Health Summary Score
Hide Description SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Physical Health Summary Score is derived from four individual domains (physical functioning, role physical, bodily pain and general health).
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. There were 13 subjects on Dysport and 24 on placebo who were not assessed on the change in physical health summary at Week 8. There was no imputation of missing scores, so these 37 subjects were not taken into account.
Arm/Group Title Dysport 500 Units Placebo
Hide Arm/Group Description:
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Overall Number of Participants Analyzed 42 37
Mean (Standard Deviation)
Unit of Measure: points on a scale
Change in SF-36 Physical health summary score 4.37  (5.46) -0.64  (6.41)
Baseline SF-36 Physical health summary score 39.42  (8.84) 43.18  (7.89)
Week 8 SF-36 Physical health summary score 43.70  (8.76) 42.49  (8.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport 500 Units, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.
Method ANCOVA
Comments Treatment group, baseline SF-36 physical health summary score, center and previous treatment by botulinum toxin or not were fitted in ANCOVA model.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.66
Confidence Interval 95%
1.73 to 7.58
Estimation Comments Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 37 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)
12.Secondary Outcome
Title Number of Participants Considered by the Investigator to be Overall Treatment Successes
Hide Description The number of participants considered to be overall treatment successes by the investigator at week 12 was assessed.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on intention to treat population which consisted of 55 participants on Dysport and 61 on Placebo.
Arm/Group Title Dysport 500 Units Placebo
Hide Arm/Group Description:
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
Overall Number of Participants Analyzed 55 61
Measure Type: Number
Unit of Measure: participants
32 10
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport 500 Units, Placebo
Comments The number of participants considered treatment successes was analysed using a logistic model with treatment, strata (naive or non-naive) and center as factors in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.
Method odds ratio
Comments The odds ratio represents the odds of success on Dysport versus Placebo stratified for strata and country
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.206
Confidence Interval 95%
3.01 to 17.26
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dysport 500 Units Placebo
Hide Arm/Group Description Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
All-Cause Mortality
Dysport 500 Units Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dysport 500 Units Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/55 (0.00%)      1/61 (1.64%)    
Psychiatric disorders     
Suicide attempt * 1  0/55 (0.00%)  0 1/61 (1.64%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dysport 500 Units Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/55 (20.00%)      5/61 (8.20%)    
Gastrointestinal disorders     
Dysphagia * 1  5/55 (9.09%)  5 0/61 (0.00%)  0
General disorders     
Injection site pain * 1  3/55 (5.45%)  3 2/61 (3.28%)  2
Musculoskeletal and connective tissue disorders     
Neck pain * 1  3/55 (5.45%)  4 3/61 (4.92%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
A publication of results from all sites in this multicenter study is expected. If the sponsor no longer plans this or 6 months after study completion at all sites, the PI may publish the results. He will supply any proposed publication to the sponsor for review and comment at least 30 days before submission for publication. If the sponsor believes a patent application should be filed, the publication will be delayed for another 60 days or until patent filing; with a maximum delay of 90 days.
Results Point of Contact
Name/Title: Senior Director, Medical Development, Neurology
Organization: Ipsen
Responsible Party: Jean-Loic Robin, Ipsen
ClinicalTrials.gov Identifier: NCT00257660     History of Changes
Other Study ID Numbers: Y-47-52120-051
First Submitted: November 22, 2005
First Posted: November 23, 2005
Results First Submitted: January 6, 2010
Results First Posted: May 10, 2010
Last Update Posted: February 8, 2019