Trial Outcomes & Findings for Open-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia (NCT NCT00288509)
NCT ID: NCT00288509
Last Updated: 2022-09-28
Results Overview
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.
COMPLETED
PHASE3
108 participants
Week 4 follow-up visit
2022-09-28
Participant Flow
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).
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.
Participant milestones
| Measure |
Dysport
250-1000 units
|
|---|---|
|
Treatment Cycle 1
STARTED
|
108
|
|
Treatment Cycle 1
COMPLETED
|
102
|
|
Treatment Cycle 1
NOT COMPLETED
|
6
|
|
Treatment Cycle 2
STARTED
|
100
|
|
Treatment Cycle 2
COMPLETED
|
97
|
|
Treatment Cycle 2
NOT COMPLETED
|
3
|
|
Treatment Cycle 3
STARTED
|
96
|
|
Treatment Cycle 3
COMPLETED
|
91
|
|
Treatment Cycle 3
NOT COMPLETED
|
5
|
|
Treatment Cycle 4
STARTED
|
88
|
|
Treatment Cycle 4
COMPLETED
|
80
|
|
Treatment Cycle 4
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Dysport
250-1000 units
|
|---|---|
|
Treatment Cycle 1
Adverse Event
|
1
|
|
Treatment Cycle 1
Lack of Efficacy
|
1
|
|
Treatment Cycle 1
Withdrawal by Subject
|
1
|
|
Treatment Cycle 1
Lost to Follow-up
|
2
|
|
Treatment Cycle 1
Treatment stopped according to protocol
|
1
|
|
Treatment Cycle 2
Lack of Efficacy
|
1
|
|
Treatment Cycle 2
Withdrawal by Subject
|
2
|
|
Treatment Cycle 3
Lack of Efficacy
|
1
|
|
Treatment Cycle 3
Withdrawal by Subject
|
1
|
|
Treatment Cycle 3
Lost to Follow-up
|
2
|
|
Treatment Cycle 3
Treatment stopped according to protocol
|
1
|
|
Treatment Cycle 4
Withdrawal by Subject
|
3
|
|
Treatment Cycle 4
Physician Decision
|
4
|
|
Treatment Cycle 4
Treatment stopped according to protocol
|
1
|
Baseline Characteristics
Open-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
Baseline characteristics by cohort
| Measure |
Dysport
n=108 Participants
250-1000 units
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
89 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=99 Participants
|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 13.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
81 participants
n=99 Participants
|
|
Region of Enrollment
Russian Federation
|
27 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Week 4 follow-up visitPopulation: 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.
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.
Outcome measures
| Measure |
Dysport
n=108 Participants
250-1000 units
|
|---|---|
|
Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
Week 4 TWSTRS total score for Treatment Cycle 1
|
25.81 points on a scale
Standard Deviation 12.83
|
|
Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
Change in TWSTRS total score for Treatment Cycle 2
|
-11.40 points on a scale
Standard Deviation 10.83
|
|
Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
Baseline TWSTRS total score for Treatment Cycle 2
|
34.72 points on a scale
Standard Deviation 11.12
|
|
Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
Week 4 TWSTRS total score for Treatment Cycle 2
|
23.40 points on a scale
Standard Deviation 12.55
|
|
Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
Change in TWSTRS total score for Treatment Cycle 3
|
-10.84 points on a scale
Standard Deviation 13.00
|
|
Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
Baseline TWSTRS total score for Treatment Cycle 3
|
32.66 points on a scale
Standard Deviation 11.68
|
|
Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
Week 4 TWSTRS total score for Treatment Cycle 3
|
21.84 points on a scale
Standard Deviation 12.45
|
|
Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
Change in TWSTRS total score for Treatment Cycle 4
|
-11.27 points on a scale
Standard Deviation 11.46
|
|
Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
Baseline TWSTRS total score for Treatment Cycle 4
|
34.35 points on a scale
Standard Deviation 12.81
|
|
Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
Week 4 TWSTRS total score for Treatment Cycle 4
|
23.07 points on a scale
Standard Deviation 12.62
|
|
Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
Change in TWSTRS total score for Treatment Cycle 1
|
-16.21 points on a scale
Standard Deviation 11.54
|
|
Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
Baseline TWSTRS total score for Treatment Cycle 1
|
42.48 points on a scale
Standard Deviation 10.23
|
SECONDARY outcome
Timeframe: Week 4 follow-up visitPopulation: 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.
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.
Outcome measures
| Measure |
Dysport
n=108 Participants
250-1000 units
|
|---|---|
|
Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline
Change in TWSTRS severity score for cycle 1
|
-7.68 points on a scale
Standard Deviation 5.72
|
|
Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline
Baseline TWSTRS severity score for cycle 1
|
19.79 points on a scale
Standard Deviation 4.29
|
|
Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline
Week 4 TWSTRS severity score for cycle 1
|
11.90 points on a scale
Standard Deviation 5.54
|
|
Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline
Week 4 TWSTRS severity score for cycle 2
|
10.54 points on a scale
Standard Deviation 5.43
|
|
Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline
Change in TWSTRS severity score for cycle 3
|
-5.68 points on a scale
Standard Deviation 6.21
|
|
Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline
Change in TWSTRS severity score for cycle 2
|
-5.52 points on a scale
Standard Deviation 5.54
|
|
Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline
Baseline TWSTRS severity score for cycle 2
|
16.05 points on a scale
Standard Deviation 5.10
|
|
Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline
Baseline TWSTRS severity score for cycle 3
|
15.79 points on a scale
Standard Deviation 5.32
|
|
Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline
Week 4 TWSTRS severity score for cycle 3
|
10.23 points on a scale
Standard Deviation 5.95
|
|
Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline
Change in TWSTRS severity score for cycle 4
|
-5.78 points on a scale
Standard Deviation 5.57
|
|
Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline
Baseline TWSTRS severity score for cycle 4
|
16.53 points on a scale
Standard Deviation 5.64
|
|
Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline
Week 4 TWSTRS severity score for cycle 4
|
10.96 points on a scale
Standard Deviation 5.95
|
SECONDARY outcome
Timeframe: Week 4 follow-up visitPopulation: 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.
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.
Outcome measures
| Measure |
Dysport
n=108 Participants
250-1000 units
|
|---|---|
|
Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline
Week 4 TWSTRS disability score for cycle 2
|
7.63 points on a scale
Standard Deviation 4.83
|
|
Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline
Change in TWSTRS disability score for cycle 3
|
-2.74 points on a scale
Standard Deviation 4.44
|
|
Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline
Baseline TWSTRS disability score for cycle 3
|
9.73 points on a scale
Standard Deviation 4.27
|
|
Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline
Week 4 TWSTRS disability score for cycle 3
|
6.97 points on a scale
Standard Deviation 4.67
|
|
Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline
Change in TWSTRS disability score for cycle 1
|
-4.25 points on a scale
Standard Deviation 4.39
|
|
Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline
Baseline TWSTRS disability score for cycle 1
|
12.70 points on a scale
Standard Deviation 4.31
|
|
Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline
Week 4 TWSTRS disability score for cycle 1
|
8.51 points on a scale
Standard Deviation 5.22
|
|
Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline
Change in TWSTRS disability score for cycle 4
|
-2.54 points on a scale
Standard Deviation 3.16
|
|
Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline
Baseline TWSTRS disability score for cycle 4
|
10.09 points on a scale
Standard Deviation 4.91
|
|
Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline
Week 4 TWSTRS disability score for cycle 4
|
7.46 points on a scale
Standard Deviation 5.07
|
|
Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline
Change in TWSTRS disability score for cycle 2
|
-2.88 points on a scale
Standard Deviation 3.86
|
|
Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline
Baseline TWSTRS disability score for cycle 2
|
10.45 points on a scale
Standard Deviation 4.56
|
SECONDARY outcome
Timeframe: Week 4 follow-up visitPopulation: 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.
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.
Outcome measures
| Measure |
Dysport
n=108 Participants
250-1000 units
|
|---|---|
|
Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline
Change in TWSTRS pain score for cycle 1
|
-4.53 points on a scale
Standard Deviation 4.57
|
|
Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline
Baseline TWSTRS pain score for cycle 1
|
10.08 points on a scale
Standard Deviation 4.64
|
|
Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline
Week 4 TWSTRS pain score for cycle 1
|
5.37 points on a scale
Standard Deviation 4.97
|
|
Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline
Change in TWSTRS pain score for cycle 3
|
-2.41 points on a scale
Standard Deviation 5.04
|
|
Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline
Week 4 TWSTRS pain score for cycle 3
|
4.65 points on a scale
Standard Deviation 5.01
|
|
Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline
Change in TWSTRS pain score for cycle 4
|
-2.81 points on a scale
Standard Deviation 4.85
|
|
Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline
Change in TWSTRS pain score for cycle 2
|
-2.99 points on a scale
Standard Deviation 4.27
|
|
Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline
Baseline TWSTRS pain score for cycle 2
|
8.12 points on a scale
Standard Deviation 5.35
|
|
Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline
Week 4 TWSTRS pain score for cycle 2
|
5.22 points on a scale
Standard Deviation 5.34
|
|
Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline
Baseline TWSTRS pain score for cycle 3
|
7.16 points on a scale
Standard Deviation 5.19
|
|
Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline
Baseline TWSTRS pain score for cycle 4
|
7.72 points on a scale
Standard Deviation 5.57
|
|
Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline
Week 4 TWSTRS pain score for cycle 4
|
4.97 points on a scale
Standard Deviation 5.14
|
Adverse Events
Dysport
Serious adverse events
| Measure |
Dysport
n=108 participants at risk
250-1000 units
|
|---|---|
|
Infections and infestations
Appendicitis
|
0.93%
1/108 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.93%
1/108 • Number of events 1
|
Other adverse events
| Measure |
Dysport
n=108 participants at risk
250-1000 units
|
|---|---|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
27/108 • Number of events 45
|
|
Nervous system disorders
Headache
|
6.5%
7/108 • Number of events 8
|
|
Infections and infestations
Influenza
|
9.3%
10/108 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
14.8%
16/108 • Number of events 29
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.3%
10/108 • Number of events 13
|
|
Infections and infestations
Urinary tract infection
|
8.3%
9/108 • Number of events 12
|
|
Infections and infestations
Upper respiratory tract infection
|
4.6%
5/108 • Number of events 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER