Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 46 of 116 for:    cervical | "dopa-responsive dystonia" OR "Dystonia"

IncobotulinumtoxinA (Xeomin) Versus Placebo in 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: NCT00407030
Recruitment Status : Completed
First Posted : December 4, 2006
Results First Posted : December 31, 2010
Last Update Posted : July 19, 2013
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Cervical Dystonia
Interventions Drug: incobotulinumtoxinA (Xeomin) (240 Units)
Drug: incobotulinumtoxinA (Xeomin) (120 Units)
Drug: Placebo
Enrollment 233
Recruitment Details  
Pre-assignment Details  
Arm/Group Title incobotulinumtoxinA (Xeomin) (240 Units) incobotulinumtoxinA (Xeomin) (120 Units) Placebo
Hide Arm/Group Description incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Period Title: Main Period - 8 to 20 Weeks
Started 81 78 74
Completed 76 75 68
Not Completed 5 3 6
Reason Not Completed
Adverse Event             2             1             0
Lack of Efficacy             0             0             3
Lost to Follow-up             1             1             1
Consent Withdrawn             1             1             1
Withdrawal Criteria Occurred             0             0             1
Patient Decision             1             0             0
Period Title: Extension Period - up to 68 Weeks
Started 111 [1] 103 [1] 0 [2]
Completed 84 74 0
Not Completed 27 29 0
Reason Not Completed
Withdrawal Criteria Occurred             4             5             0
Lack of Efficacy             11             11             0
Adverse Event             1             0             0
Consent Withdrawn             4             4             0
Lost to Follow-up             5             5             0
Patient Decision             1             2             0
Physician Decision             1             2             0
[1]
2 subjects did not enter the Ext. Period, 3 subjects never expressed any need for a new injection
[2]
After the Main Period all patients were randomly assigned to the 2 active treatment arms.
Arm/Group Title incobotulinumtoxinA (Xeomin) (240 Units) incobotulinumtoxinA (Xeomin) (120 Units) Placebo Total
Hide Arm/Group Description incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection Total of all reporting groups
Overall Number of Baseline Participants 81 78 74 233
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants 78 participants 74 participants 233 participants
53.2  (12.2) 52.8  (11.5) 52.4  (10.8) 52.8  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 78 participants 74 participants 233 participants
Female
54
  66.7%
51
  65.4%
49
  66.2%
154
  66.1%
Male
27
  33.3%
27
  34.6%
25
  33.8%
79
  33.9%
1.Primary Outcome
Title Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo
Hide Description

The TWSTRS-Total score is the sum of scores of the three components of the scale:

  • TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)
  • TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)
  • TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).

The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.

Time Frame Baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value
Arm/Group Title incobotulinumtoxinA (Xeomin) (240 Units) Placebo
Hide Arm/Group Description:
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Overall Number of Participants Analyzed 81 74
Least Squares Mean (Standard Error)
Unit of Measure: points on a scale
-7.3  (2.18) 1.6  (2.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection incobotulinumtoxinA (Xeomin) (240 Units), Placebo
Comments Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Due to the hierarchical testing no adjustment of type I error was necessary.
Method ANCOVA
Comments Independent variables in the model were treatment, baseline TWSTRS-Total score, gender, age, pre-treatment of cervical dystonia, and pooled center.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.0
Confidence Interval (2-Sided) 95%
-12.0 to -5.9
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (120 Units) Versus Placebo
Hide Description

The TWSTRS-Total score is the sum of scores of the three components of the scale:

  • TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)
  • TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)
  • TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).

The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.

Time Frame Baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value
Arm/Group Title incobotulinumtoxinA (Xeomin) (120 Units) Placebo
Hide Arm/Group Description:
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Overall Number of Participants Analyzed 78 74
Least Squares Mean (Standard Error)
Unit of Measure: points on a scale
-10.8  (2.11) -3.3  (2.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection incobotulinumtoxinA (Xeomin) (120 Units), Placebo
Comments Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Due to the hierarchical testing no adjustment of type I error was necessary.
Method ANCOVA
Comments Independent variables in the model were treatment, baseline TWSTRS-Total score, gender, age, pre-treatment of cervical dystonia, and pooled center.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.5
Confidence Interval (2-Sided) 95%
-10.4 to -4.6
Estimation Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Xeomin (120 Units)
Hide Description

The TWSTRS-Total score is the sum of scores of the three components of the scale:

  • TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)
  • TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)
  • TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).

The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.

Time Frame Baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value
Arm/Group Title incobotulinumtoxinA (Xeomin) (240 Units) incobotulinumtoxinA (Xeomin) (120 Units)
Hide Arm/Group Description:
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection
Overall Number of Participants Analyzed 81 78
Least Squares Mean (Standard Error)
Unit of Measure: points on a scale
-10.5  (2.25) -9.2  (2.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection incobotulinumtoxinA (Xeomin) (240 Units), incobotulinumtoxinA (Xeomin) (120 Units)
Comments Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.447
Comments Due to the hierarchical testing no adjustment of type I error was necessary.
Method ANCOVA
Comments Independent variables in the model were treatment, baseline TWSTRS-Total score, gender, age, pre-treatment of cervical dystonia, and pooled center.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
-2.1 to 4.6
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in the TWSTRS-Total Score
Hide Description

The TWSTRS-Total score is the sum of scores of the three components of the scale:

  • TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)
  • TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)
  • TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).

The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.

Time Frame Baseline, week 8, final visit (up to 20 weeks after injection of the Main Period)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value
Arm/Group Title incobotulinumtoxinA (Xeomin) (240 Units) incobotulinumtoxinA (Xeomin) (120 Units) Placebo
Hide Arm/Group Description:
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Overall Number of Participants Analyzed 81 78 74
Mean (Standard Deviation)
Unit of Measure: points on a scale
Baseline - Week 8 -8.2  (10.54) -6.9  (11.15) 0.4  (7.17)
Baseline - Final Visit -4.6  (7.52) -3.6  (8.07) 1.7  (6.15)
5.Secondary Outcome
Title Change From Baseline in the TWSTRS Disability Subscore
Hide Description TWSTRS-Disability score which ranges from 0 (=no disability)to 30 (=maximum disability). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Time Frame Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value
Arm/Group Title incobotulinumtoxinA (Xeomin) (240 Units) incobotulinumtoxinA (Xeomin) (120 Units) Placebo
Hide Arm/Group Description:
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Overall Number of Participants Analyzed 81 78 74
Mean (Standard Deviation)
Unit of Measure: points on a scale
Baseline - Week 4 -3.0  (4.35) -3.3  (4.72) 0.0  (3.41)
Baseline - Week 8 -2.4  (3.98) -2.1  (4.86) 0.8  (3.27)
Baseline - Final Visit -1.3  (3.13) -1.4  (3.82) 1.0  (3.32)
6.Secondary Outcome
Title Change From Baseline in the TWSTRS Severity Subscore
Hide Description TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Time Frame Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value
Arm/Group Title incobotulinumtoxinA (Xeomin) (240 Units) incobotulinumtoxinA (Xeomin) (120 Units) Placebo
Hide Arm/Group Description:
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Overall Number of Participants Analyzed 81 78 74
Mean (Standard Deviation)
Unit of Measure: points on a scale
Baseline - Week 4 -5.5  (5.99) -3.9  (4.34) -1.9  (3.96)
Baseline - Week 8 -3.5  (5.39) -3.1  (4.39) -0.9  (3.57)
Baseline - Final Visit -1.9  (3.83) -1.1  (3.18) -0.2  (3.07)
7.Secondary Outcome
Title Change From Baseline in the TWSTRS Pain Subscore
Hide Description TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Time Frame Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value
Arm/Group Title incobotulinumtoxinA (Xeomin) (240 Units) incobotulinumtoxinA (Xeomin) (120 Units) Placebo
Hide Arm/Group Description:
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Overall Number of Participants Analyzed 81 78 74
Mean (Standard Deviation)
Unit of Measure: points on a scale
Baseline - Week 4 -2.4  (4.36) -2.7  (4.55) -0.3  (2.97)
Baseline - Week 8 -2.3  (4.32) -1.8  (4.15) 0.6  (2.82)
Baseline - Final Visit -1.3  (3.40) -1.1  (3.96) 0.9  (2.56)
8.Secondary Outcome
Title Patient Evaluation of Global Response (PEGR) at Final Visit
Hide Description The PEGR is a descriptive subjective 9-point response scale ranging from "complete abolishment of signs and symptoms" (value=+4) down to "very marked worsening" (value=-4).
Time Frame Final visit (up to 20 weeks after injection of the Main Period)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population with missing values imputed by "no effect"
Arm/Group Title incobotulinumtoxinA (Xeomin) (240 Units) incobotulinumtoxinA (Xeomin) (120 Units) Placebo
Hide Arm/Group Description:
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
Overall Number of Participants Analyzed 81 78 74
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.3  (1.84) 1.3  (1.77) -0.2  (1.34)
Time Frame All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
Adverse Event Reporting Description The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
 
Arm/Group Title incobotulinumtoxinA (Xeomin) (240 Units) incobotulinumtoxinA (Xeomin) (120 Units) Placebo
Hide Arm/Group Description incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
All-Cause Mortality
incobotulinumtoxinA (Xeomin) (240 Units) incobotulinumtoxinA (Xeomin) (120 Units) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
incobotulinumtoxinA (Xeomin) (240 Units) incobotulinumtoxinA (Xeomin) (120 Units) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/81 (4.94%)      0/78 (0.00%)      0/74 (0.00%)    
Infections and infestations       
Appendicitis  1  1/81 (1.23%)  1 0/78 (0.00%)  0 0/74 (0.00%)  0
Staphylococcal infection  1  1/81 (1.23%)  1 0/78 (0.00%)  0 0/74 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Asthma  1  1/81 (1.23%)  1 0/78 (0.00%)  0 0/74 (0.00%)  0
Chronic obstructive pulmonary disease  1  1/81 (1.23%)  1 0/78 (0.00%)  0 0/74 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
incobotulinumtoxinA (Xeomin) (240 Units) incobotulinumtoxinA (Xeomin) (120 Units) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/81 (33.33%)      26/78 (33.33%)      14/74 (18.92%)    
Gastrointestinal disorders       
Dysphagia  1  15/81 (18.52%)  17 9/78 (11.54%)  10 2/74 (2.70%)  2
General disorders       
Injection site pain  1  3/81 (3.70%)  3 7/78 (8.97%)  7 4/74 (5.41%)  5
Infections and infestations       
Nasopharyngitis  1  0/81 (0.00%)  0 3/78 (3.85%)  3 5/74 (6.76%)  5
Musculoskeletal and connective tissue disorders       
Muscular weakness  1  9/81 (11.11%)  12 5/78 (6.41%)  5 1/74 (1.35%)  1
Musculosceletal pain  1  3/81 (3.70%)  4 6/78 (7.69%)  8 1/74 (1.35%)  1
Neck pain  1  12/81 (14.81%)  13 4/78 (5.13%)  7 3/74 (4.05%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
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.
No results to be published without written agreement by sponsor; manuscripts to be sent to sponsor at least 6 weeks before submission. Sponsor to give written opinion within 30 days. Sponsor is entitled to exert influence on the contents of publications, to postpone publications up to 36 months after end of the study, and to name co-authors. In case of justified doubts of sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
Results Point of Contact
Name/Title: Angelika Hanschmann
Organization: Merz Pharmaceuticals GmbH
Phone: ++49-69-1503 ext 538
Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00407030     History of Changes
Other Study ID Numbers: MRZ 60201-0408
First Submitted: November 30, 2006
First Posted: December 4, 2006
Results First Submitted: August 31, 2010
Results First Posted: December 31, 2010
Last Update Posted: July 19, 2013