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Long Term Safety And Effectiveness Of Dysport® In Adults With 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: NCT01753336
Recruitment Status : Completed
First Posted : December 20, 2012
Results First Posted : May 4, 2017
Last Update Posted : May 4, 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
Condition Cervical Dystonia
Intervention Drug: Dysport®
Enrollment 112
Recruitment Details This was an open label extension (OLE) study for study A-TL-52120-169 (Study 169). First subject enrolled: 14 March 2013; last subject completed: 13 October 2015. A-TL-52120-170 (Study 170) was conducted in 36 centres in the United States that had participated in Study 169 and enrolled adult subjects with cervical dystonia (CD).
Pre-assignment Details Subjects who completed Study 169 and had no on-going Adverse Events (AEs) or whose Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score between Weeks 4 and 8 was reduced by ≤15% from baseline were invited to participate in this OLE study. 112 of the 134 subjects in Study 169 were enrolled into Study 170 (signed informed consent).
Arm/Group Title Total Dysport®
Hide Arm/Group Description Subjects received up to 3 doses of Dysport® 500 Units (U)/vial, 2 millilitre (mL) dilution on Day 1 of up to 3 treatment cycles. Subjects who were botulinum neurotoxin (BoNT) treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum toxin type A haemagglutinin complex (abobotulinumtoxinA).
Period Title: Overall Study
Started 112
Cycle 1 112
Cycle 2 98
Cycle 3 93
Completed 92
Not Completed 20
Reason Not Completed
Patient decision             12
Lost to Follow-up             3
Physician Decision             2
Sponsor's decision             2
Withdrawal by Subject             1
Arm/Group Title Total Dysport®
Hide Arm/Group Description Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
Overall Number of Baseline Participants 112
Hide Baseline Analysis Population Description
The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 112 participants
18-24 years 0
25-34 years 1
35-44 years 13
45-54 years 34
55-64 years 33
65-74 years 26
+75 years 5
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants
Female
70
  62.5%
Male
42
  37.5%
1.Primary Outcome
Title TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.
Hide Description Mean TWSTRS total scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.
Time Frame Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Mean TWSTRS score at Cycle 1-Day 1 Number Analyzed 112 participants
37.7  (13.58)
Mean TWSTRS score at Cycle 1-Week 4 Number Analyzed 102 participants
30.1  (13.16)
Mean TWSTRS score at Cycle 1-Week 12/Cycle 2-Day 1 Number Analyzed 98 participants
32.6  (11.96)
Mean TWSTRS score at Cycle 2-Week 4 Number Analyzed 96 participants
27.0  (12.07)
Mean TWSTRS score at Cycle 2-Week 12/Cycle 3-Day 1 Number Analyzed 92 participants
31.1  (12.51)
Mean TWSTRS score at Cycle 3-Week 4 Number Analyzed 91 participants
27.4  (13.10)
Mean TWSTRS score at Cycle 3-Week 12 Number Analyzed 92 participants
30.1  (12.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 is presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -8.0
Confidence Interval (2-Sided) 95%
-9.79 to -6.28
Parameter Dispersion
Type: Standard Deviation
Value: 8.94
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 1-Day 1 vs Cycle 1-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 is presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5.0
Confidence Interval (2-Sided) 95%
-7.36 to -2.68
Parameter Dispersion
Type: Standard Deviation
Value: 11.68
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 2-Day 1 vs Cycle 2-Week 4. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 is presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5.9
Confidence Interval (2-Sided) 95%
-7.42 to -4.47
Parameter Dispersion
Type: Standard Deviation
Value: 7.29
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 is presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-3.37 to -0.27
Parameter Dispersion
Type: Standard Deviation
Value: 7.49
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.1
Confidence Interval (2-Sided) 95%
-5.99 to -2.20
Parameter Dispersion
Type: Standard Deviation
Value: 9.03
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 3-Day 1 vs Cycle 3-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-3.11 to 0.81
Parameter Dispersion
Type: Standard Deviation
Value: 9.42
Estimation Comments [Not Specified]
2.Secondary Outcome
Title TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.
Hide Description The pretreatment baseline scores were defined as the TWSTRS measurement before Dysport® treatment in Study 169 for subjects who had received Dysport® in Study 169 and Day 1 of Study 170 for those subjects who had received placebo. Mean TWSTRS total scores for pretreatment baseline and for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from pretreatment baseline scores at Week 4 and Week 12 of each treatment cycle are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline for Studies 169 and 170 and at all post-treatment visits of each treatment cycle.
Time Frame Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Mean TWSTRS score at baseline for Study 169 Number Analyzed 112 participants
42.2  (10.30)
Mean TWSTRS score at Cycle 1-Week 4 Number Analyzed 102 participants
30.1  (13.16)
Mean TWSTRS score at Cycle 1-Week 12 Number Analyzed 98 participants
32.6  (11.96)
Mean TWSTRS score at Cycle 2-Week 4 Number Analyzed 96 participants
27.0  (12.07)
Mean TWSTRS score at Cycle 2-Week 12 Number Analyzed 92 participants
31.1  (12.51)
Mean TWSTRS score at Cycle 3-Week 4 Number Analyzed 91 participants
27.4  (13.10)
Mean TWSTRS score at Cycle 3-Week 12 Number Analyzed 92 participants
30.1  (12.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Pretreatment baseline vs Cycle 1-Week 4. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 4 visit for Treatment Cycle 1 is presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -11.5
Confidence Interval (2-Sided) 95%
-13.38 to -9.56
Parameter Dispersion
Type: Standard Deviation
Value: 9.74
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Pretreatment baseline vs Cycle 1-Week 12. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 12 visit for treatment Cycle 1 is presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -8.9
Confidence Interval (2-Sided) 95%
-11.08 to -6.71
Parameter Dispersion
Type: Standard Deviation
Value: 10.89
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Pretreatment baseline vs Cycle 2-Week 4. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 4 visit for Treatment Cycle 2 is presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -14.4
Confidence Interval (2-Sided) 95%
-16.74 to -12.11
Parameter Dispersion
Type: Standard Deviation
Value: 11.43
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Pretreatment baseline vs Cycle 2-Week 12. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 12 visit for Treatment Cycle 2 is presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -10.6
Confidence Interval (2-Sided) 95%
-12.92 to -8.22
Parameter Dispersion
Type: Standard Deviation
Value: 11.33
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Pretreatment baseline vs Cycle 3-Week 4. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 4 visit for Treatment Cycle 3 is presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -14.6
Confidence Interval (2-Sided) 95%
-17.18 to -12.10
Parameter Dispersion
Type: Standard Deviation
Value: 12.19
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Pretreatment baseline vs Cycle 3-Week 12. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 12 visit for Treatment Cycle 3 is presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -11.7
Confidence Interval (2-Sided) 95%
-14.02 to -9.39
Parameter Dispersion
Type: Standard Deviation
Value: 11.17
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Treatment Response in Treatment Cycle 3 Week 4.
Hide Description Treatment response was defined as a reduction in the TWSTRS total score of at least 30% from pretreatment baseline to the Week 4 visit in Treatment Cycle 3. The pretreatment baseline scores were defined as the TWSTRS measurement before Dysport® treatment in Study 169 for subjects who had previously received Dysport® in Study 169 and Day 1 of Study 170 for those subjects who had previously received placebo. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline for Studies 169 and 170 and at all post-treatment visits of each treatment cycle. The proportion (percentage) of subjects who were treatment responders at Week 4 of Treatment Cycle 3 are presented.
Time Frame Week 4 Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit. For Treatment Cycle 3 there were 91 evaluable subjects.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
Overall Number of Participants Analyzed 91
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
51.6
(40.93 to 62.26)
4.Secondary Outcome
Title TWSTRS Severity Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.
Hide Description Mean TWSTRS severity subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS severity subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for treatment cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The severity subscale gives a score from 0 to 35, with higher values indicating a worse outcome of physical findings of CD. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.
Time Frame Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Mean severity score at Cycle 1-Day 1 Number Analyzed 112 participants
17.3  (4.69)
Mean severity score at Cycle 1-Week 4 Number Analyzed 102 participants
13.9  (5.21)
Mean severity score Cycle 1-Week 12/Cycle 2-Day 1 Number Analyzed 98 participants
15.7  (4.97)
Mean severity score at Cycle 2-Week 4 Number Analyzed 96 participants
12.8  (4.97)
Mean severity score Cycle 2-Week12/Cycle 3-Day 1 Number Analyzed 92 participants
15.3  (4.87)
Mean severity score at Cycle 3-Week 4 Number Analyzed 91 participants
12.7  (5.78)
Mean severity score at Cycle 3-Week 12 Number Analyzed 92 participants
14.3  (5.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 was determined.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.5
Confidence Interval (2-Sided) 95%
-4.46 to -2.52
Parameter Dispersion
Type: Standard Deviation
Value: 4.95
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 1-Day 1 vs Cycle 1-Week 12. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 was determined.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-2.81 to -0.70
Parameter Dispersion
Type: Standard Deviation
Value: 5.24
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 2-Day 1 vs Cycle 2-Week 4. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 was determined.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.0
Confidence Interval (2-Sided) 95%
-3.75 to -2.23
Parameter Dispersion
Type: Standard Deviation
Value: 3.77
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 was determined.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-1.33 to 0.27
Parameter Dispersion
Type: Standard Deviation
Value: 3.86
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.7
Confidence Interval (2-Sided) 95%
-3.64 to -1.83
Parameter Dispersion
Type: Standard Deviation
Value: 4.32
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 3-Day 1 vs Cycle 3-Week 12. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-2.00 to -0.02
Parameter Dispersion
Type: Standard Deviation
Value: 4.77
Estimation Comments [Not Specified]
5.Secondary Outcome
Title TWSTRS Disability Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.
Hide Description Mean TWSTRS disability subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The disability subscale is a 6-item scale and each item is rated on a 6-point scale with higher values indicating the highest degree of disability. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.
Time Frame Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Mean disability score at Cycle 1-Day 1 Number Analyzed 112 participants
11.5  (6.63)
Mean disability score at Cycle1-Week 4 Number Analyzed 102 participants
8.8  (6.41)
Mean disability score Cycle1-Week 12/Cycle 2-Day 1 Number Analyzed 98 participants
9.4  (5.64)
Mean disability score at Cycle 2-Week 4 Number Analyzed 96 participants
7.9  (5.76)
Mean disability score Cycle2-Week 12/Cycle 3-Day 1 Number Analyzed 92 participants
8.7  (5.82)
Mean disability score at Cycle 3-Week 4 Number Analyzed 91 participants
8.1  (6.07)
Mean disability score at Cycle 3-Week 12 Number Analyzed 92 participants
8.6  (6.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 was determined.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.9
Confidence Interval (2-Sided) 95%
-3.64 to -2.12
Parameter Dispersion
Type: Standard Deviation
Value: 3.86
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 1-Day 1 vs Cycle 1-Week 12.The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 was determined.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-2.79 to -0.86
Parameter Dispersion
Type: Standard Deviation
Value: 4.82
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 2-Day 1 vs Cycle 2-Week 4. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 was determined.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-2.44 to -1.04
Parameter Dispersion
Type: Standard Deviation
Value: 3.47
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 was determined.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-1.55 to -0.12
Parameter Dispersion
Type: Standard Deviation
Value: 3.46
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.45 to 0.12
Parameter Dispersion
Type: Standard Deviation
Value: 3.75
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 3-Day 1 vs Cycle 3-Week 12.The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.85 to 0.70
Parameter Dispersion
Type: Standard Deviation
Value: 3.73
Estimation Comments [Not Specified]
6.Secondary Outcome
Title TWSTRS Pain Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.
Hide Description Mean TWSTRS pain subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The pain subscale gives a score from 0 to 20, with higher values indicating greater pain experienced. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.
Time Frame Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.
Arm/Group Title Total Dysport®
Hide Arm/Group Description:
Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Mean pain score at Cycle 1-Day 1 Number Analyzed 112 participants
9.0  (5.32)
Mean pain score at Cycle 1-Week 4 Number Analyzed 102 participants
7.4  (5.10)
Mean pain score at Cycle 1-Week 12/Cycle 2-Day 1 Number Analyzed 98 participants
7.5  (5.03)
Mean pain score at Cycle 2- Week 4 Number Analyzed 96 participants
6.3  (5.11)
Mean pain score at Cycle 2-Week 12/Cycle 3-Day 1 Number Analyzed 92 participants
7.2  (4.98)
Mean pain score at Cycle 3-Week 4 Number Analyzed 91 participants
6.5  (5.01)
Mean pain score at Cycle 3-Week 12 Number Analyzed 92 participants
7.1  (4.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 was determined.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-2.39 to -0.92
Parameter Dispersion
Type: Standard Deviation
Value: 3.74
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 1-Day 1 vs Cycle 1-Week 12. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 was determined.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-2.22 to -0.66
Parameter Dispersion
Type: Standard Deviation
Value: 3.88
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 2-Day 1 vs Cycle 2-Week 4.The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 was determined.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-1.84 to -0.58
Parameter Dispersion
Type: Standard Deviation
Value: 3.12
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 was determined.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-1.08 to 0.18
Parameter Dispersion
Type: Standard Deviation
Value: 3.04
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.57 to 0.19
Parameter Dispersion
Type: Standard Deviation
Value: 4.20
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Total Dysport®
Comments Cycle 3-Day 1 vs Cycle 3-Week 12. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.85 to 0.73
Parameter Dispersion
Type: Standard Deviation
Value: 3.78
Estimation Comments [Not Specified]
Time Frame In Study 170 AEs were collected from Day 1 of Treatment Cycle 1 up to the end of study (Week 12 of Treatment Cycle 3)/early withdrawal. For subjects who received Dysport® in Study 169, AEs were collected over 4 Dysport® dosing cycles; 1 Dysport® dosing cycle from Study 169 and 3 Dysport® dosing cycles from Study 170 (period of up to 49 weeks). For subjects who received placebo in Study 169, AEs were collected in 3 Dysport® dosing cycles from Study 170 (period of up to 36 weeks).
Adverse Event Reporting Description Serious and non-serious treatment emergent AEs are presented for all Dysport® dosing cycles in Study 169 and Study 170. The safety population consisted of all randomised subjects who received at least 1 dose of study treatment regardless of the amount of study treatment administered and who had at least 1 safety record post-treatment or attended a post-treatment visit.
 
Arm/Group Title Total Dysport®
Hide Arm/Group Description Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. 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   7/112 (6.25%)    
Gastrointestinal disorders   
Colitis ischaemic  1  1/112 (0.89%)  1
Dysphagia  1  1/112 (0.89%)  1
Hepatobiliary disorders   
Cholecystitis  1  1/112 (0.89%)  1
Infections and infestations   
Appendicitis  1  1/112 (0.89%)  1
Injury, poisoning and procedural complications   
Thoracic vertebral fracture  1  1/112 (0.89%)  1
Musculoskeletal and connective tissue disorders   
Osteoarthritis  1  2/112 (1.79%)  2
Nervous system disorders   
Transient ischaemic attack  1  1/112 (0.89%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Total Dysport®
Affected / at Risk (%) # Events
Total   70/112 (62.50%)    
Blood and lymphatic system disorders   
Anaemia  1  1/112 (0.89%)  1
Cardiac disorders   
Tachycardia  1  2/112 (1.79%)  2
Ear and labyrinth disorders   
Ear Pain  1  1/112 (0.89%)  2
Motion Sickness  1  1/112 (0.89%)  1
Eye disorders   
Vision Blurred  1  4/112 (3.57%)  4
Dry Eye  1  1/112 (0.89%)  1
Eye Pain  1  1/112 (0.89%)  1
Ocular Hyperaemia  1  1/112 (0.89%)  1
Visual Acuity Reduced  1  1/112 (0.89%)  1
Gastrointestinal disorders   
Dysphagia  1  12/112 (10.71%)  15
Abdominal Pain  1  2/112 (1.79%)  3
Dry Mouth  1  2/112 (1.79%)  2
Nausea  1  2/112 (1.79%)  2
Constipation  1  1/112 (0.89%)  1
Diarrhoea  1  1/112 (0.89%)  1
Diverticulum Intestinal  1  1/112 (0.89%)  1
Flatulence  1  1/112 (0.89%)  1
Impaired Gastric Emptying  1  1/112 (0.89%)  1
Vomiting  1  1/112 (0.89%)  1
General disorders   
Chest Discomfort  1  1/112 (0.89%)  1
Fatigue  1  1/112 (0.89%)  1
Injection Site Pain  1  1/112 (0.89%)  1
Injection Site Reaction  1  1/112 (0.89%)  1
Pain  1  1/112 (0.89%)  1
Pyrexia  1  1/112 (0.89%)  1
Immune system disorders   
Drug Hypersensitivity  1  1/112 (0.89%)  1
Infections and infestations   
Nasopharyngitis  1  4/112 (3.57%)  4
Influenza  1  3/112 (2.68%)  3
Upper Respiratory Tract Infection  1  3/112 (2.68%)  3
Urinary Tract Infection  1  3/112 (2.68%)  3
Bronchitis  1  2/112 (1.79%)  2
Sinusitis  1  2/112 (1.79%)  2
Candidiasis  1  1/112 (0.89%)  1
Ear Infection  1  1/112 (0.89%)  1
Gastrointestinal Viral Infection  1  1/112 (0.89%)  1
Herpes Zoster  1  1/112 (0.89%)  1
Injury, poisoning and procedural complications   
Fall  1  5/112 (4.46%)  5
Clavicle Fracture  1  1/112 (0.89%)  1
Concussion  1  1/112 (0.89%)  1
Craniocerebral Injury  1  1/112 (0.89%)  1
Facial Bones Fracture  1  1/112 (0.89%)  1
Laceration  1  1/112 (0.89%)  1
Ligament Injury  1  1/112 (0.89%)  1
Meniscus Lesion  1  1/112 (0.89%)  1
Muscle Strain  1  1/112 (0.89%)  1
Post Procedural Haemorrhage  1  1/112 (0.89%)  1
Road Traffic Accident  1  1/112 (0.89%)  1
Thermal Burn  1  1/112 (0.89%)  1
Tooth Injury  1  1/112 (0.89%)  1
Investigations   
Barium Swallow  1  1/112 (0.89%)  1
Blood Bilirubin Increased  1  1/112 (0.89%)  1
Blood Cholesterol Increased  1  1/112 (0.89%)  1
Blood Testosterone Decreased  1  1/112 (0.89%)  1
Blood Triglycerides Increased  1  1/112 (0.89%)  2
Metabolism and nutrition disorders   
Decreased Appetite  1  1/112 (0.89%)  1
Dehydration  1  1/112 (0.89%)  1
Hypomagnesaemia  1  1/112 (0.89%)  1
Hypophosphataemia  1  1/112 (0.89%)  1
Musculoskeletal and connective tissue disorders   
Muscular Weakness  1  12/112 (10.71%)  16
Neck Pain  1  12/112 (10.71%)  13
Back Pain  1  3/112 (2.68%)  3
Arthralgia  1  2/112 (1.79%)  2
Muscle Spasms  1  2/112 (1.79%)  2
Muscle Tightness  1  2/112 (1.79%)  2
Muscle Weakness  1  2/112 (1.79%)  2
Musculoskeletal Stiffness  1  2/112 (1.79%)  2
Myalgia  1  2/112 (1.79%)  2
Bursitis  1  1/112 (0.89%)  1
Intervertebral Disc Degeneration  1  1/112 (0.89%)  1
Intervertebral Disc Disorder  1  1/112 (0.89%)  1
Muscle Twitching  1  1/112 (0.89%)  1
Musculoskeletal Pain  1  1/112 (0.89%)  1
Myofascial Pain Syndrome  1  1/112 (0.89%)  1
Osteopenia  1  1/112 (0.89%)  1
Pain in Extremity  1  1/112 (0.89%)  1
Sensation of Heaviness  1  1/112 (0.89%)  1
Spinal Deformity  1  1/112 (0.89%)  1
Synovial Cyst  1  1/112 (0.89%)  1
Torticollis  1  1/112 (0.89%)  1
Nervous system disorders   
Headache  1  6/112 (5.36%)  7
Dizziness  1  3/112 (2.68%)  5
Migraine  1  3/112 (2.68%)  3
Aphasia  1  1/112 (0.89%)  1
Balance Disorder  1  1/112 (0.89%)  1
Burning Sensation  1  1/112 (0.89%)  1
Dysarthria  1  1/112 (0.89%)  1
Head Discomfort  1  1/112 (0.89%)  1
Hyporeflexia  1  1/112 (0.89%)  1
Movement Disorder  1  1/112 (0.89%)  1
Presyncope  1  1/112 (0.89%)  1
Sciatica  1  1/112 (0.89%)  1
Tension Headache  1  1/112 (0.89%)  1
Tremor  1  1/112 (0.89%)  1
Psychiatric disorders   
Depression  1  2/112 (1.79%)  2
Anxiety  1  1/112 (0.89%)  1
Insomnia  1  1/112 (0.89%)  1
Sleep Disorder  1  1/112 (0.89%)  1
Tic  1  1/112 (0.89%)  1
Renal and urinary disorders   
Hydronephrosis  1  1/112 (0.89%)  1
Nephrolithiasis  1  1/112 (0.89%)  1
Urinary Incontinence  1  1/112 (0.89%)  1
Reproductive system and breast disorders   
Breast Mass  1  1/112 (0.89%)  1
Ovarian Cyst  1  1/112 (0.89%)  1
Pelvic Fluid Collection  1  1/112 (0.89%)  1
Prostatitis  1  1/112 (0.89%)  1
Respiratory, thoracic and mediastinal disorders   
Choking  1  1/112 (0.89%)  1
Cough  1  1/112 (0.89%)  1
Dyspnoea  1  1/112 (0.89%)  2
Dyspnoea Exertional  1  1/112 (0.89%)  1
Nasal Congestion  1  1/112 (0.89%)  1
Sleep Apnoea Syndrome  1  1/112 (0.89%)  1
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  2/112 (1.79%)  2
Alopecia  1  1/112 (0.89%)  1
Dermatitis Contact  1  1/112 (0.89%)  2
Erythema  1  1/112 (0.89%)  1
Pruritus  1  1/112 (0.89%)  1
Rash  1  1/112 (0.89%)  1
Seborrhoeic Dermatitis  1  1/112 (0.89%)  1
Surgical and medical procedures   
Endodontic Procedure  1  1/112 (0.89%)  1
Rotator Cuff Repair  1  1/112 (0.89%)  1
Vascular disorders   
Hematoma  1  1/112 (0.89%)  1
Hypertension  1  1/112 (0.89%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA15.0
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
Organization: Ipsen Biopharmaceuticals, Inc.
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01753336     History of Changes
Other Study ID Numbers: A-TL-52120-170
First Submitted: December 17, 2012
First Posted: December 20, 2012
Results First Submitted: January 12, 2017
Results First Posted: May 4, 2017
Last Update Posted: May 4, 2017