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Trial record 92 of 258 for:    "dopa-responsive dystonia" OR "Dystonia"

Open-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00288509
Recruitment Status : Completed
First Posted : February 8, 2006
Results First Posted : April 2, 2010
Last Update Posted : February 8, 2019
Sponsor:
Information provided by:
Ipsen

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cervical Dystonia
Intervention Drug: abobotulinumtoxinA (Dysport) 250-1000 units
Enrollment 108
Recruitment Details Patients who completed study NCT00257660 (Y-47-52120-051)were recruited in 15 centres in US and 4 centres in Russia from February 2006 to January 2008 to participate in this study NCT00288509 (Y-47-52120-731).
Pre-assignment Details Of the 116 subjects treated in study NCT00257660, 108 subjects enrolled in this extension study NCT00288509 (Y-47-52120-731). Eight subjects completed study NCT00257660 but elected not to enroll in this extension study.
Arm/Group Title Dysport
Hide Arm/Group Description 250-1000 units
Period Title: Treatment Cycle 1
Started 108
Completed 102
Not Completed 6
Reason Not Completed
Adverse Event             1
Lack of Efficacy             1
Withdrawal by Subject             1
Lost to Follow-up             2
Treatment stopped according to protocol             1
Period Title: Treatment Cycle 2
Started 100 [1]
Completed 97
Not Completed 3
Reason Not Completed
Lack of Efficacy             1
Withdrawal by Subject             2
[1]
2 subjects completed Cycle 1 but withdrew before Cycle 2 due to insufficient clinical response
Period Title: Treatment Cycle 3
Started 96 [1]
Completed 91
Not Completed 5
Reason Not Completed
Lack of Efficacy             1
Withdrawal by Subject             1
Lost to Follow-up             2
Treatment stopped according to protocol             1
[1]
One subject completed Cycle 2 but withdrew before Cycle 3 due to insufficient clinical response
Period Title: Treatment Cycle 4
Started 88 [1]
Completed 80
Not Completed 8
Reason Not Completed
Withdrawal by Subject             3
Physician Decision             4
Treatment stopped according to protocol             1
[1]
3 subjects completed Cycle 3 but withdrew before Cycle 4, treatment stopped according to protocol
Arm/Group Title Dysport
Hide Arm/Group Description 250-1000 units
Overall Number of Baseline Participants 108
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants
<=18 years
0
   0.0%
Between 18 and 65 years
89
  82.4%
>=65 years
19
  17.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants
53.5  (13.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants
Female
67
  62.0%
Male
41
  38.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 108 participants
United States 81
Russian Federation 27
1.Primary Outcome
Title Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
Hide Description TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. For each treatment cycle, the change in TWSTRS total score is the score at week 4 minus the score at baseline.
Time Frame Week 4 follow-up visit
Hide Outcome Measure Data
Hide Analysis Population Description

The intention to treat population consisted of all 108 subjects who received Dysport.

Subjects with incomplete TWSTRS scores were not included in the TWSTRS total score analyses.

Arm/Group Title Dysport
Hide Arm/Group Description:
250-1000 units
Overall Number of Participants Analyzed 108
Mean (Standard Deviation)
Unit of Measure: points on a scale
Change in TWSTRS total score for Treatment Cycle 1 -16.21  (11.54)
Baseline TWSTRS total score for Treatment Cycle 1 42.48  (10.23)
Week 4 TWSTRS total score for Treatment Cycle 1 25.81  (12.83)
Change in TWSTRS total score for Treatment Cycle 2 -11.40  (10.83)
Baseline TWSTRS total score for Treatment Cycle 2 34.72  (11.12)
Week 4 TWSTRS total score for Treatment Cycle 2 23.40  (12.55)
Change in TWSTRS total score for Treatment Cycle 3 -10.84  (13.00)
Baseline TWSTRS total score for Treatment Cycle 3 32.66  (11.68)
Week 4 TWSTRS total score for Treatment Cycle 3 21.84  (12.45)
Change in TWSTRS total score for Treatment Cycle 4 -11.27  (11.46)
Baseline TWSTRS total score for Treatment Cycle 4 34.35  (12.81)
Week 4 TWSTRS total score for Treatment Cycle 4 23.07  (12.62)
2.Secondary Outcome
Title Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline
Hide Description TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for severity is from 0 (absence of severity) to 35 (max severity). For each treatment cycle, the change in TWSTRS severity subscale is the score at week 4 minus the score at baseline.
Time Frame Week 4 follow-up visit
Hide Outcome Measure Data
Hide Analysis Population Description

The intention to treat population consisted of all 108 subjects who received Dysport.

All available TWSTRS severity subscale scores have been included in the severity subscale analyses. Subjects excluded from the TWSTRS total score analyses may have their available data included in the TWSTRS severity subscale score analyses.

Arm/Group Title Dysport
Hide Arm/Group Description:
250-1000 units
Overall Number of Participants Analyzed 108
Mean (Standard Deviation)
Unit of Measure: points on a scale
Change in TWSTRS severity score for cycle 1 -7.68  (5.72)
Baseline TWSTRS severity score for cycle 1 19.79  (4.29)
Week 4 TWSTRS severity score for cycle 1 11.90  (5.54)
Change in TWSTRS severity score for cycle 2 -5.52  (5.54)
Baseline TWSTRS severity score for cycle 2 16.05  (5.10)
Week 4 TWSTRS severity score for cycle 2 10.54  (5.43)
Change in TWSTRS severity score for cycle 3 -5.68  (6.21)
Baseline TWSTRS severity score for cycle 3 15.79  (5.32)
Week 4 TWSTRS severity score for cycle 3 10.23  (5.95)
Change in TWSTRS severity score for cycle 4 -5.78  (5.57)
Baseline TWSTRS severity score for cycle 4 16.53  (5.64)
Week 4 TWSTRS severity score for cycle 4 10.96  (5.95)
3.Secondary Outcome
Title Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline
Hide Description TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for disability is from 0 (no disability) to 30 (max disability). For each treatment cycle, the change in TWSTRS disability subscale is the score at week 4 minus the score at baseline.
Time Frame Week 4 follow-up visit
Hide Outcome Measure Data
Hide Analysis Population Description

The intention to treat population consisted of all 108 subjects who received Dysport.

All available TWSTRS disability subscale scores have been included in the disability subscale analyses. Subjects excluded from the TWSTRS total score analyses may have their available data included in the TWSTRS disability subscale score analyses.

Arm/Group Title Dysport
Hide Arm/Group Description:
250-1000 units
Overall Number of Participants Analyzed 108
Mean (Standard Deviation)
Unit of Measure: points on a scale
Change in TWSTRS disability score for cycle 1 -4.25  (4.39)
Baseline TWSTRS disability score for cycle 1 12.70  (4.31)
Week 4 TWSTRS disability score for cycle 1 8.51  (5.22)
Change in TWSTRS disability score for cycle 2 -2.88  (3.86)
Baseline TWSTRS disability score for cycle 2 10.45  (4.56)
Week 4 TWSTRS disability score for cycle 2 7.63  (4.83)
Change in TWSTRS disability score for cycle 3 -2.74  (4.44)
Baseline TWSTRS disability score for cycle 3 9.73  (4.27)
Week 4 TWSTRS disability score for cycle 3 6.97  (4.67)
Change in TWSTRS disability score for cycle 4 -2.54  (3.16)
Baseline TWSTRS disability score for cycle 4 10.09  (4.91)
Week 4 TWSTRS disability score for cycle 4 7.46  (5.07)
4.Secondary Outcome
Title Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline
Hide Description TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for pain is from 0 (no pain) to 20 (max pain). For each treatment cycle, the change in TWSTRS pain subscale is the score at week 4 minus the score at baseline.
Time Frame Week 4 follow-up visit
Hide Outcome Measure Data
Hide Analysis Population Description

The intention to treat population consisted of all 108 subjects who received Dysport.

All available TWSTRS pain subscale scores have been included in the pain subscale analyses. Subjects excluded from the TWSTRS total score analyses may have their available data included in the TWSTRS pain subscale score analyses.

Arm/Group Title Dysport
Hide Arm/Group Description:
250-1000 units
Overall Number of Participants Analyzed 108
Mean (Standard Deviation)
Unit of Measure: points on a scale
Change in TWSTRS pain score for cycle 1 -4.53  (4.57)
Baseline TWSTRS pain score for cycle 1 10.08  (4.64)
Week 4 TWSTRS pain score for cycle 1 5.37  (4.97)
Change in TWSTRS pain score for cycle 2 -2.99  (4.27)
Baseline TWSTRS pain score for cycle 2 8.12  (5.35)
Week 4 TWSTRS pain score for cycle 2 5.22  (5.34)
Change in TWSTRS pain score for cycle 3 -2.41  (5.04)
Baseline TWSTRS pain score for cycle 3 7.16  (5.19)
Week 4 TWSTRS pain score for cycle 3 4.65  (5.01)
Change in TWSTRS pain score for cycle 4 -2.81  (4.85)
Baseline TWSTRS pain score for cycle 4 7.72  (5.57)
Week 4 TWSTRS pain score for cycle 4 4.97  (5.14)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dysport
Hide Arm/Group Description 250-1000 units
All-Cause Mortality
Dysport
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dysport
Affected / at Risk (%) # Events
Total   2/108 (1.85%)    
Infections and infestations   
Appendicitis * 1  1/108 (0.93%)  1
Renal and urinary disorders   
Nephrolithiasis * 1  1/108 (0.93%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dysport
Affected / at Risk (%) # Events
Total   84/108 (77.78%)    
Gastrointestinal disorders   
Dysphagia * 1  27/108 (25.00%)  45
Infections and infestations   
Influenza * 1  10/108 (9.26%)  12
Urinary tract infection * 1  9/108 (8.33%)  12
Upper respiratory tract infection * 1  5/108 (4.63%)  5
Musculoskeletal and connective tissue disorders   
Muscular weakness * 1  16/108 (14.81%)  29
Neck pain * 1  10/108 (9.26%)  13
Nervous system disorders   
Headache * 1  7/108 (6.48%)  8
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A publication of results from all sites in this multicenter study is expected. If the sponsor no longer plans this or 6 months after study completion at all sites, the PI may publish the results. He will supply any proposed publication to the sponsor for review and comment at least 30 days before submission for publication. If the sponsor believes a patent application should be filed, the publication will be delayed for another 60 days or until patent filing; with a maximum delay of 90 days.
Results Point of Contact
Name/Title: Senior Director, Medical Development, Neurology
Organization: Ipsen
Responsible Party: Jean-Loic Robin, Ipsen
ClinicalTrials.gov Identifier: NCT00288509     History of Changes
Other Study ID Numbers: Y-47-52120-731
First Submitted: February 7, 2006
First Posted: February 8, 2006
Results First Submitted: January 6, 2010
Results First Posted: April 2, 2010
Last Update Posted: February 8, 2019