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Trial record 70 of 259 for:    "dopa-responsive dystonia" OR "Dystonia"

Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.

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ClinicalTrials.gov Identifier: NCT01753310
Recruitment Status : Completed
First Posted : December 20, 2012
Results First Posted : March 16, 2017
Last Update Posted : March 16, 2017
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Cervical Dystonia
Interventions Drug: Dysport®
Drug: Placebo
Enrollment 134
Recruitment Details First subject enrolled: 7 January 2013; last subject completed: 9 January 2015. 46 investigational sites in the United States of America were planned, 43 sites were initiated and 38 sites enrolled adult subjects with cervical dystonia (CD).
Pre-assignment Details 150 subjects were screened; 16 subjects failed screening. 134 subjects were enrolled (signed informed consent) and were randomised with a 2:1 ratio of Dysport®:placebo. Randomisation was also stratified for subjects who were Botulinum toxin type A (BoNT-A) treatment naive or non-naive at baseline.
Arm/Group Title Dysport® Placebo
Hide Arm/Group Description Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA). Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
Period Title: Overall Study
Started 89 45
Completed 57 21
Not Completed 32 24
Reason Not Completed
Entered into open label extension study             25             22
Adverse Event             1             0
Lost to Follow-up             2             0
Subject decision             2             2
Sponsor decision             1             0
Withdrawal by Subject             1             0
Arm/Group Title Dysport® Placebo Total Title
Hide Arm/Group Description Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA). Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®. [Not Specified]
Overall Number of Baseline Participants 89 45 134
Hide Baseline Analysis Population Description
The baseline characteristics are presented for the Intent to Treat (ITT) Population which consisted of all randomised subjects.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 89 participants 45 participants 134 participants
18-24 years 0 0 0
25-34 years 2 2 4
35-44 years 9 4 13
45-54 years 26 14 40
55-64 years 26 12 38
65-74 years 22 11 33
>75 years 4 2 6
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 45 participants 134 participants
Female
59
  66.3%
28
  62.2%
87
  64.9%
Male
30
  33.7%
17
  37.8%
47
  35.1%
1.Primary Outcome
Title Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4.
Hide Description The change from baseline in the TWSTRS total score at Week 4 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. 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 and at all post-treatment visits.
Time Frame 4 weeks post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The modified ITT population consisted of all randomised subjects with both a baseline and a Week 4 post-treatment TWSTRS total score assessment.
Arm/Group Title Dysport® Placebo
Hide Arm/Group Description:
Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
Overall Number of Participants Analyzed 84 45
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (Day 1) Pre-treatment 42.5  (10.40) 42.4  (10.63)
Week 4 Post-treatment 31.7  (15.29) 39.9  (12.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport®, Placebo
Comments The superiority of Dysport® to placebo was tested at a two-tailed 5% level by using a stratified analysis of covariance (ANCOVA) with baseline TWSTRS total score as covariate and stratified by the randomisation stratification factor (BoNT-A naïve versus BoNT-A non-naïve).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments The 2 sided t-test was on weighted overall treatment difference.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -8.3
Confidence Interval (2-Sided) 95%
-12.17 to -4.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.95
Estimation Comments Based on the sample size weighted overall treatment difference.
2.Secondary Outcome
Title Change From Baseline in TWSTRS Total Score at Week 2.
Hide Description The change from baseline in the TWSTRS total score at Week 2 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. 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 and at all post-treatment visits.
Time Frame 2 weeks post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomised subjects.
Arm/Group Title Dysport® Placebo
Hide Arm/Group Description:
Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
Overall Number of Participants Analyzed 89 45
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (Day 1) pre-treatment 42.1  (10.77) 42.4  (10.63)
Week 2 post-treatment 34.5  (14.54) 39.8  (12.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport®, Placebo
Comments The superiority of Dysport® to placebo was tested at a two-tailed 5% level by using a stratified ANCOVA with baseline TWSTRS total score as covariate and stratified by the randomisation stratification factor (BoNT-A naïve versus BoNT-A non-naïve).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments The 2 sided t-test was on weighted overall treatment difference.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -5.4
Confidence Interval (2-Sided) 95%
-8.67 to -2.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.65
Estimation Comments Based on the sample size weighted overall treatment difference.
3.Secondary Outcome
Title Change From Baseline in Clinical Global Impression of Change (CGIC) in CD at Week 2.
Hide Description The CGIC is an investigator-reported assessment of the global clinical change in CD since study treatment administration. The CGIC uses a seven-point Likert scale ranging from +3 (very much improved) to -3 (very much worse), and was assessed by the investigator at the Week 2 and Week 4 visits.
Time Frame 2 weeks post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 4 subjects (3 from the Dysport® arm and 1 from the Placebo arm) had missing values for CGIC.
Arm/Group Title Dysport® Placebo
Hide Arm/Group Description:
Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
Overall Number of Participants Analyzed 86 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.2  (1.32) -0.0  (1.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport®, Placebo
Comments The superiority of Dysport® to placebo on CGIC of CD was tested at a two-tailed 5% level by using an analysis of variance (ANOVA) with treatment and randomisation stratification factor as main effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title TWSTRS Responders at Week 2.
Hide Description Treatment response was determined as the number of responders at Week 2 relative to the baseline TWSTRS total score. A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment. This was calculated as ([Week 2 score - baseline score]/baseline score) * 100.
Time Frame 2 weeks post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomised subjects.
Arm/Group Title Dysport® Placebo
Hide Arm/Group Description:
Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
Overall Number of Participants Analyzed 89 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
27.9
(18.8 to 38.6)
11.4
(3.8 to 24.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport®, Placebo
Comments The superiorty of Dysport® to placebo on treatment response was tested at a two-tailed 5% level by using a Mantel-Haenszel chi-squared test stratified by the randomisation factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.033
Comments [Not Specified]
Method Mantel-Haenszel chi-squared test
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in CGIC in CD at Week 4.
Hide Description The CGIC is an investigator-reported assessment of the global clinical change in CD since study treatment administration. The CGIC uses a seven-point Likert scale ranging from +3 (very much improved) to -3 (very much worse), and was assessed by the investigator at the Week 2 and Week 4 visits.
Time Frame 4 weeks post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 3 subjects (all from the Dysport® arm) had missing values for CGIC.
Arm/Group Title Dysport® Placebo
Hide Arm/Group Description:
Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
Overall Number of Participants Analyzed 86 45
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.2  (1.50) 0.1  (1.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport®, Placebo
Comments The superiority of Dysport® to placebo on CGIC of CD was tested at a two-tailed 5% level by using an ANOVA with treatment and randomisation stratification factor as main effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title TWSTRS Responders at Week 4.
Hide Description Treatment response was determined as the number of responders at Week 4 relative to the baseline TWSTRS total score. A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment. This was calculated as ([Week 4 score - baseline score]/baseline score) * 100.
Time Frame 4 weeks post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomised subjects.
Arm/Group Title Dysport® Placebo
Hide Arm/Group Description:
Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
Overall Number of Participants Analyzed 89 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
41.9
(31.3 to 53.0)
11.1
(3.7 to 24.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport®, Placebo
Comments The superiorty of Dysport® to placebo on treatment response was tested at a two-tailed 5% level by using a Mantel-Haenszel chi-squared test stratified by the randomisation factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mantel-Haenszel chi-squared test
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Cervical Dystonia Impact Profile-58 (CDIP-58) Total Score at Week 4.
Hide Description The CDIP-58 scale is a subject-based rating scale measuring the health impact of CD measured in 8 health dimensions including head and neck symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood and psychosocial functioning. Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Negative changes from the baseline total score indicate improvement in the impact of CD on health whereas postive changes indicate worsening.
Time Frame 4 weeks post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 8 subjects (7 from the Dysport® arm and 1 from the Placebo arm) had missing values for CDIP-58.
Arm/Group Title Dysport® Placebo
Hide Arm/Group Description:
Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
Overall Number of Participants Analyzed 82 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
-8.5  (14.26) -4.7  (16.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport®, Placebo
Comments The superiority of Dysport® to placebo on CDIP-58 was tested at a two-tailed 5% level by using an ANOVA with treatment and randomisation stratification factor as main effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.174
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in CDIP-58 Total Score at Week 2.
Hide Description The CDIP-58 scale is a subject-based rating scale measuring the health impact of CD measured in 8 health dimensions including head and neck symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood and psychosocial functioning. Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Negative changes from the baseline total score indicate improvement in the impact of CD on health whereas postive changes indicate worsening. The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint (change from baseline in CDIP-58 total score at Week 4) reached a statistically significant treatment effect. This secondary efficacy endpoint (change from baseline in CDIP-58 total score at Week 2) was performed to characterise the full clinical effect.
Time Frame 2 weeks post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 8 subjects (6 from the Dysport® arm and 2 from the Placebo arm) had missing values for CDIP-58.
Arm/Group Title Dysport® Placebo
Hide Arm/Group Description:
Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
Overall Number of Participants Analyzed 83 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.8  (13.96) -4.3  (14.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport®, Placebo
Comments The superiority of Dysport® to placebo on CDIP-58 was tested at a two-tailed 5% level by using an ANOVA with treatment and randomisation stratification factor as main effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.583
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Adverse Event Reporting Description Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
 
Arm/Group Title Dysport® Placebo
Hide Arm/Group Description Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA). Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
All-Cause Mortality
Dysport® Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dysport® Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/88 (4.55%)      1/45 (2.22%)    
Gastrointestinal disorders     
Dysphagia  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon neoplasm  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Endometrial cancer  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Nervous system disorders     
Transient Ischaemic Attack  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Psychiatric disorders     
Depression  1  0/88 (0.00%)  0 1/45 (2.22%)  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%
Dysport® Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/88 (39.77%)      10/45 (22.22%)    
Eye disorders     
Vision blurred  1  2/88 (2.27%)  2 0/45 (0.00%)  0
Dry eye  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Visual Impairment  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Gastrointestinal disorders     
Diarrhoea  1  2/88 (2.27%)  2 0/45 (0.00%)  0
Dysphagia  1  7/88 (7.95%)  7 0/45 (0.00%)  0
Flatulence  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Dry mouth  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Epigastric discomfort  1  0/88 (0.00%)  0 1/45 (2.22%)  1
General disorders     
Pain  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Fatigue  1  2/88 (2.27%)  2 0/45 (0.00%)  0
Gait disturbance  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Infections and infestations     
Sinusitis  1  3/88 (3.41%)  3 0/45 (0.00%)  0
Bronchitis  1  2/88 (2.27%)  2 0/45 (0.00%)  0
Upper respiratory tract infection  1  0/88 (0.00%)  0 1/45 (2.22%)  1
Ear infection  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Injury, poisoning and procedural complications     
Tongue injury  1  0/88 (0.00%)  0 1/45 (2.22%)  1
Post injection phenomenon  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Animal bite  1  0/88 (0.00%)  0 1/45 (2.22%)  1
Meniscus injury  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Investigations     
Blood triglycerides increased  1  1/88 (1.14%)  1 1/45 (2.22%)  1
Blood bilirubin increased  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Blood potassium decreased  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Blood cholesterol increased  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Hypertriglyceridaemia  1  0/88 (0.00%)  0 1/45 (2.22%)  1
Hypercholesterolaemia  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscular weakness  1  8/88 (9.09%)  8 0/45 (0.00%)  0
Neck Pain  1  7/88 (7.95%)  7 0/45 (0.00%)  0
Myalgia  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Back pain  1  0/88 (0.00%)  0 2/45 (4.44%)  2
Muscle spasms  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Musculoskeletal pain  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Muscle twitching  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Sensation of heaviness  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Nervous system disorders     
Burning sensation  1  2/88 (2.27%)  2 0/45 (0.00%)  0
Presyncope  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Hypoaesthesia  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Headache  1  5/88 (5.68%)  5 0/45 (0.00%)  0
Dizziness  1  1/88 (1.14%)  2 2/45 (4.44%)  2
Tension headache  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Psychiatric disorders     
Depression  1  2/88 (2.27%)  2 0/45 (0.00%)  0
Insomnia  1  1/88 (1.14%)  1 1/45 (2.22%)  1
Renal and urinary disorders     
Urinary incontinence  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Skin and subcutaneous tissue disorders     
Skin hyperpigmentation  1  0/88 (0.00%)  0 1/45 (2.22%)  1
Pruritus  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Hyperhidrosis  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Alopecia  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Surgical and medical procedures     
Endodontic procedure  1  1/88 (1.14%)  1 0/45 (0.00%)  0
Tooth extraction  1  0/88 (0.00%)  0 1/45 (2.22%)  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: NCT01753310     History of Changes
Other Study ID Numbers: A-TL-52120-169
First Submitted: December 17, 2012
First Posted: December 20, 2012
Results First Submitted: November 8, 2016
Results First Posted: March 16, 2017
Last Update Posted: March 16, 2017