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A Study to Compare Dysport® and Botox® in the Treatment of Cervical Dystonia

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ClinicalTrials.gov Identifier: NCT00950664
Recruitment Status : Completed
First Posted : August 3, 2009
Results First Posted : October 11, 2013
Last Update Posted : July 5, 2017
Sponsor:
Collaborators:
Ipsen
Medical Research Collaborating Center, Seoul, Korea
Information provided by (Responsible Party):
BS Jeon, Seoul National University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cervical Dystonia
Interventions Drug: Dysport® (abobotulinumtoxinA)
Drug: Botox® (onabotulinumtoxinA)
Enrollment 103
Recruitment Details Participants recruited from movement disorder clinics at 7 hospitals in Korea, between August 2009 and March 2010.
Pre-assignment Details 103 participants recruited; 103 screened, 1 excluded (1 refused participation).
Arm/Group Title Dysport® First, Then Botox® Botox® First, Then Dysport®
Hide Arm/Group Description Dysport® injection in first intervention period and Botox® in second intervention period (after washout period) Botox® injection in first intervention period and Dysport® in second intervention period (after washout period)
Period Title: First Intervention
Started 49 53
Completed 46 48
Not Completed 3 5
Reason Not Completed
Lost to Follow-up             1             3
Withdrawal by Subject             2             2
Period Title: Washout Period of 4 Weeks
Started 46 48
Completed 46 48
Not Completed 0 0
Period Title: Second Intervention
Started 46 48
Completed 0 0
Not Completed 46 48
Arm/Group Title Dysport® First, Then Botox® Botox® First, Then Dysport® Total
Hide Arm/Group Description Dysport® injection in first intervention period and Botox® in second intervention period (after washout period) Botox® injection in first intervention period and Dysport® in second intervention period (after washout period) Total of all reporting groups
Overall Number of Baseline Participants 46 48 94
Hide Baseline Analysis Population Description
All analyses were performed on the modified intention-to-treat (mITT) basis, with all subjects included in the two treatment challenges.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 48 participants 94 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
38
  82.6%
42
  87.5%
80
  85.1%
>=65 years
8
  17.4%
6
  12.5%
14
  14.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 48 participants 94 participants
53.24  (11.44) 53.35  (10.18) 53.29  (10.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 48 participants 94 participants
Female
26
  56.5%
31
  64.6%
57
  60.6%
Male
20
  43.5%
17
  35.4%
37
  39.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 46 participants 48 participants 94 participants
46 48 94
1.Primary Outcome
Title Reduction of Total Tsui Score at 4 Weeks From Baseline
Hide Description

Tsui scale is an impairment scale which evaluates the amplitude and duration of sustained posture and intermittent movements of the head, as well as the presence of shoulder elevation and tremor.

Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale.

Time Frame 4 weeks after injection from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dysport® (abobotulinumtoxinA) Botox® (onabotulinumtoxinA)
Hide Arm/Group Description:
Dysport® administered in either first intervention period or second intervention period
Botox® administered in either first intervention period or second intervention period
Overall Number of Participants Analyzed 94 94
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.98  (3.89) -4.77  (4.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dysport® (abobotulinumtoxinA), Botox® (onabotulinumtoxinA)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments 81 participants required to detect 5 difference in Tsui score, with 80% power. 20% drop out rate assumed, 102 participants needed. Alpha level of 0.05.
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Paired-t test
Comments [Not Specified]
2.Secondary Outcome
Title Reduction of Total TWSTRS Score at 4 Weeks From Baseline
Hide Description

TWSTRS (Toronto western spasmodic torticollis rating scale) The TWSTRS is a composite scale which covers different features of cervical dystonia(CD).

The first part is based on the physical findings (severity subscale), the second part rates disability, and the third part pain.

(range: 0-80, higher values represent worse cervical dystonia.) Details of the TWSTRS are displayed on the Web site http://www.wemove.org. Negative numbers to represent decreases of TWSTRS.

Time Frame 4 weeks after injection from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dysport® (abobotulinumtoxinA) Botox® (onabotulinumtoxinA)
Hide Arm/Group Description:
Dysport® administered in either first intervention period or second intervention period
Botox® administered in either first intervention period or second intervention period
Overall Number of Participants Analyzed 94 94
Mean (Standard Deviation)
Unit of Measure: units on a scale
-9.76  (10.25) -8.78  (10.11)
3.Secondary Outcome
Title CGI-I (Clinical Global Impression of Illness)
Hide Description

The proportion of patients with ‘normal/ not at all ill’ or ‘borderline mildly ill’ on the CGI (Clinical global impression of illness, CGI-I)

1 = normal / not at all ill’; 2 = ‘borderline mildly ill’; 3 = ‘mildly ill’; 4 = ‘moderlately ill’; 5 = ‘markedly ill’; 6 = ‘severely ill’; 7 = ‘the most extremely ill’.

Time Frame 4, 8, 12 and 16 weeks after injection
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dysport® (abobotulinumtoxinA) Botox® (onabotulinumtoxinA)
Hide Arm/Group Description:
Dysport® administered in either first intervention period or second intervention period
Botox® administered in either first intervention period or second intervention period
Overall Number of Participants Analyzed 94 94
Measure Type: Number
Unit of Measure: percentage of participants scoring 1or2
4 weeks after injection 16.0 13.8
8 weeks after injection 16.0 14.9
12 weeks after injection 11.7 14.9
16 weeks after injection 8.5 11.7
4.Secondary Outcome
Title PGI-I (Patient's Global Impression of Improvement)
Hide Description

The proportion of patients with 'very much improved' or 'much improved' on the PGI (Patient's global impression of impairment, PGI-I)

1 = very much improved, 2= much improved, 3 = slightly improved, 4 = no change, 5 = slightly aggravated, 6 = much aggravated, and 7 = very much aggravated

Time Frame 4, 8, 12 and 16 weeks after injection
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dysport® (abobotulinumtoxinA) Botox® (onabotulinumtoxinA)
Hide Arm/Group Description:
Dysport® administered in either first intervention period or second intervention period
Botox® administered in either first intervention period or second intervention period
Overall Number of Participants Analyzed 94 94
Measure Type: Number
Unit of Measure: percentage of patients scoring 1 or 2
4 weeks after injection 35.1 36.2
8 weeks after injection 33.0 36.2
12 weeks after injection 20.2 27.7
16 weeks after injection 7.4 9.6
5.Other Pre-specified Outcome
Title Reduction of Tsui Score at Each Visit From Baseline
Hide Description Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale.
Time Frame 8, 12 and 16 weeks after injection
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dysport® (abobotulinumtoxinA) Botox® (onabotulinumtoxinA)
Hide Arm/Group Description:
Dysport® administered in either first intervention period or second intervention period
Botox® administered in either first intervention period or second intervention period
Overall Number of Participants Analyzed 94 94
Mean (Standard Deviation)
Unit of Measure: units on a scale
Reduction in Tsui Score at 8 Weeks from Baseline -4.33  (3.69) -4.23  (4.08)
Reduction in Tsui Score at 12 Weeks from Baseline -3.20  (4.48) -3.31  (4.18)
Reduction in Tsui Score at 16 Weeks from Baseline -1.69  (3.99) -1.85  (4.16)
6.Other Pre-specified Outcome
Title Reduction of Total TWSTRS at Each Visit From Baseline
Hide Description TWSTRS scale (Toronto western spasmodic torticollis rating scale, range: 0-80, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of TWSTRS scale.
Time Frame 8, 12 and 16 weeks after injection
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dysport® (abobotulinumtoxinA) Botox® (onabotulinumtoxinA)
Hide Arm/Group Description:
Dysport® administered in either first intervention period or second intervention period
Botox® administered in either first intervention period or second intervention period
Overall Number of Participants Analyzed 94 94
Mean (Standard Deviation)
Unit of Measure: units on a scale
Reduction of TWSTRS from Baseline at 8 Weeks -11.16  (10.85) -9.98  (9.90)
Reduction of TWSTRS from Baseline at 12 Weeks -8.95  (11.64) -8.66  (10.45)
Reduction of TWSTRS from Baseline at 16 Weeks -5.15  (8.73) -5.34  (9.76)
7.Other Pre-specified Outcome
Title Reduction of Pain Associated With Cervical Dystonia at Each Visit From Baseline
Hide Description Pain subscale of TWSTRS scale.(Range: 0-20) Negative numbers to represent decreases of TWSTRS pain subscale.
Time Frame 4, 8, 12 and 16 weeks after injection
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dysport® (abobotulinumtoxinA) Botox® (onabotulinumtoxinA)
Hide Arm/Group Description:
Dysport® administered in either first intervention period or second intervention period
Botox® administered in either first intervention period or second intervention period
Overall Number of Participants Analyzed 94 94
Mean (Standard Deviation)
Unit of Measure: units on a scale
4 weeks after injections -1.45  (4.05) -1.19  (4.16)
8 weeks after injections -1.96  (3.97) -2.28  (3.50)
12 weeks after injections -1.40  (4.08) -2.07  (3.97)
16 weeks after injections -0.97  (3.85) -1.76  (3.75)
Time Frame 4 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dysport® (abobotulinumtoxinA) Botox® (onabotulinumtoxinA)
Hide Arm/Group Description Dysport® administered in either first intervention period or second intervention period Botox® administered in either first intervention period or second intervention period
All-Cause Mortality
Dysport® (abobotulinumtoxinA) Botox® (onabotulinumtoxinA)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/94 (0.00%)      0/94 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Dysport® (abobotulinumtoxinA) Botox® (onabotulinumtoxinA)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/94 (0.00%)      0/94 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dysport® (abobotulinumtoxinA) Botox® (onabotulinumtoxinA)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/94 (14.89%)      19/94 (20.21%)    
Musculoskeletal and connective tissue disorders     
Muscle weakness *  9/94 (9.57%)  9 13/94 (13.83%)  13
Dysphagia *  6/94 (6.38%)  6 12/94 (12.77%)  12
Pain on neck and shoulder *  2/94 (2.13%)  2 7/94 (7.45%)  7
*
Indicates events were collected by non-systematic assessment
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: BS Jeon
Organization: Seoul National University Hospital
Phone: +82220722876
Responsible Party: BS Jeon, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00950664     History of Changes
Other Study ID Numbers: H-0902-049-272
First Submitted: July 29, 2009
First Posted: August 3, 2009
Results First Submitted: February 8, 2013
Results First Posted: October 11, 2013
Last Update Posted: July 5, 2017