Trial Outcomes & Findings for A Study to Compare Dysport® and Botox® in the Treatment of Cervical Dystonia (NCT NCT00950664)

NCT ID: NCT00950664

Last Updated: 2017-07-05

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 103 participants
• Primary outcome timeframe: 4 weeks after injection from baseline
• Results posted on: 2017-07-05

Participant Flow

Participants recruited from movement disorder clinics at 7 hospitals in Korea, between August 2009 and March 2010.

103 participants recruited; 103 screened, 1 excluded (1 refused participation).

Participant milestones

Measure	Dysport® First, Then Botox® Dysport® injection in first intervention period and Botox® in second intervention period (after washout period)	Botox® First, Then Dysport® Botox® injection in first intervention period and Dysport® in second intervention period (after washout period)
First Intervention STARTED	49	53
First Intervention COMPLETED	46	48
First Intervention NOT COMPLETED	3	5
Washout Period of 4 Weeks STARTED	46	48
Washout Period of 4 Weeks COMPLETED	46	48
Washout Period of 4 Weeks NOT COMPLETED	0	0
Second Intervention STARTED	46	48
Second Intervention COMPLETED	0	0
Second Intervention NOT COMPLETED	46	48

Reasons for withdrawal

Measure	Dysport® First, Then Botox® Dysport® injection in first intervention period and Botox® in second intervention period (after washout period)	Botox® First, Then Dysport® Botox® injection in first intervention period and Dysport® in second intervention period (after washout period)
First Intervention Lost to Follow-up	1	3
First Intervention Withdrawal by Subject	2	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Dysport® First, Then Botox® n=46 Participants Dysport® injection in first intervention period and Botox® in second intervention period (after washout period)	Botox® First, Then Dysport® n=48 Participants Botox® injection in first intervention period and Dysport® in second intervention period (after washout period)	Total n=94 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=93 Participants	42 Participants n=4 Participants	80 Participants n=27 Participants
Age, Categorical >=65 years	8 Participants n=93 Participants	6 Participants n=4 Participants	14 Participants n=27 Participants
Age, Continuous	53.24 years STANDARD_DEVIATION 11.44 • n=93 Participants	53.35 years STANDARD_DEVIATION 10.18 • n=4 Participants	53.29 years STANDARD_DEVIATION 10.76 • n=27 Participants
Sex: Female, Male Female	26 Participants n=93 Participants	31 Participants n=4 Participants	57 Participants n=27 Participants
Sex: Female, Male Male	20 Participants n=93 Participants	17 Participants n=4 Participants	37 Participants n=27 Participants
Region of Enrollment Korea, Republic of	46 participants n=93 Participants	48 participants n=4 Participants	94 participants n=27 Participants

PRIMARY outcome

Timeframe: 4 weeks after injection from baseline

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.

Outcome measures

Measure	Dysport® (abobotulinumtoxinA) n=94 Participants Dysport® administered in either first intervention period or second intervention period	Botox® (onabotulinumtoxinA) n=94 Participants Botox® administered in either first intervention period or second intervention period
Reduction of Total Tsui Score at 4 Weeks From Baseline	-3.98 units on a scale Standard Deviation 3.89	-4.77 units on a scale Standard Deviation 4.10

SECONDARY outcome

Timeframe: 4 weeks after injection from baseline

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.

Outcome measures

Measure	Dysport® (abobotulinumtoxinA) n=94 Participants Dysport® administered in either first intervention period or second intervention period	Botox® (onabotulinumtoxinA) n=94 Participants Botox® administered in either first intervention period or second intervention period
Reduction of Total TWSTRS Score at 4 Weeks From Baseline	-9.76 units on a scale Standard Deviation 10.25	-8.78 units on a scale Standard Deviation 10.11

SECONDARY outcome

Timeframe: 4, 8, 12 and 16 weeks after injection

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'.

Outcome measures

Measure	Dysport® (abobotulinumtoxinA) n=94 Participants Dysport® administered in either first intervention period or second intervention period	Botox® (onabotulinumtoxinA) n=94 Participants Botox® administered in either first intervention period or second intervention period
CGI-I (Clinical Global Impression of Illness) 4 weeks after injection	16.0 percentage of participants scoring 1or2	13.8 percentage of participants scoring 1or2
CGI-I (Clinical Global Impression of Illness) 8 weeks after injection	16.0 percentage of participants scoring 1or2	14.9 percentage of participants scoring 1or2
CGI-I (Clinical Global Impression of Illness) 12 weeks after injection	11.7 percentage of participants scoring 1or2	14.9 percentage of participants scoring 1or2
CGI-I (Clinical Global Impression of Illness) 16 weeks after injection	8.5 percentage of participants scoring 1or2	11.7 percentage of participants scoring 1or2

SECONDARY outcome

Timeframe: 4, 8, 12 and 16 weeks after injection

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

Outcome measures

Measure	Dysport® (abobotulinumtoxinA) n=94 Participants Dysport® administered in either first intervention period or second intervention period	Botox® (onabotulinumtoxinA) n=94 Participants Botox® administered in either first intervention period or second intervention period
PGI-I (Patient's Global Impression of Improvement) 4 weeks after injection	35.1 percentage of patients scoring 1 or 2	36.2 percentage of patients scoring 1 or 2
PGI-I (Patient's Global Impression of Improvement) 8 weeks after injection	33.0 percentage of patients scoring 1 or 2	36.2 percentage of patients scoring 1 or 2
PGI-I (Patient's Global Impression of Improvement) 12 weeks after injection	20.2 percentage of patients scoring 1 or 2	27.7 percentage of patients scoring 1 or 2
PGI-I (Patient's Global Impression of Improvement) 16 weeks after injection	7.4 percentage of patients scoring 1 or 2	9.6 percentage of patients scoring 1 or 2

OTHER_PRE_SPECIFIED outcome

Timeframe: 8, 12 and 16 weeks after injection

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

Outcome measures

Measure	Dysport® (abobotulinumtoxinA) n=94 Participants Dysport® administered in either first intervention period or second intervention period	Botox® (onabotulinumtoxinA) n=94 Participants Botox® administered in either first intervention period or second intervention period
Reduction of Tsui Score at Each Visit From Baseline Reduction in Tsui Score at 8 Weeks from Baseline	-4.33 units on a scale Standard Deviation 3.69	-4.23 units on a scale Standard Deviation 4.08
Reduction of Tsui Score at Each Visit From Baseline Reduction in Tsui Score at 12 Weeks from Baseline	-3.20 units on a scale Standard Deviation 4.48	-3.31 units on a scale Standard Deviation 4.18
Reduction of Tsui Score at Each Visit From Baseline Reduction in Tsui Score at 16 Weeks from Baseline	-1.69 units on a scale Standard Deviation 3.99	-1.85 units on a scale Standard Deviation 4.16

OTHER_PRE_SPECIFIED outcome

Timeframe: 8, 12 and 16 weeks after injection

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.

Outcome measures

Measure	Dysport® (abobotulinumtoxinA) n=94 Participants Dysport® administered in either first intervention period or second intervention period	Botox® (onabotulinumtoxinA) n=94 Participants Botox® administered in either first intervention period or second intervention period
Reduction of Total TWSTRS at Each Visit From Baseline Reduction of TWSTRS from Baseline at 8 Weeks	-11.16 units on a scale Standard Deviation 10.85	-9.98 units on a scale Standard Deviation 9.90
Reduction of Total TWSTRS at Each Visit From Baseline Reduction of TWSTRS from Baseline at 12 Weeks	-8.95 units on a scale Standard Deviation 11.64	-8.66 units on a scale Standard Deviation 10.45
Reduction of Total TWSTRS at Each Visit From Baseline Reduction of TWSTRS from Baseline at 16 Weeks	-5.15 units on a scale Standard Deviation 8.73	-5.34 units on a scale Standard Deviation 9.76

OTHER_PRE_SPECIFIED outcome

Timeframe: 4, 8, 12 and 16 weeks after injection

Pain subscale of TWSTRS scale.(Range: 0-20) Negative numbers to represent decreases of TWSTRS pain subscale.

Outcome measures

Measure	Dysport® (abobotulinumtoxinA) n=94 Participants Dysport® administered in either first intervention period or second intervention period	Botox® (onabotulinumtoxinA) n=94 Participants Botox® administered in either first intervention period or second intervention period
Reduction of Pain Associated With Cervical Dystonia at Each Visit From Baseline 4 weeks after injections	-1.45 units on a scale Standard Deviation 4.05	-1.19 units on a scale Standard Deviation 4.16
Reduction of Pain Associated With Cervical Dystonia at Each Visit From Baseline 8 weeks after injections	-1.96 units on a scale Standard Deviation 3.97	-2.28 units on a scale Standard Deviation 3.50
Reduction of Pain Associated With Cervical Dystonia at Each Visit From Baseline 12 weeks after injections	-1.40 units on a scale Standard Deviation 4.08	-2.07 units on a scale Standard Deviation 3.97
Reduction of Pain Associated With Cervical Dystonia at Each Visit From Baseline 16 weeks after injections	-0.97 units on a scale Standard Deviation 3.85	-1.76 units on a scale Standard Deviation 3.75

Adverse Events

Dysport® (abobotulinumtoxinA)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Botox® (onabotulinumtoxinA)

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Dysport® (abobotulinumtoxinA) n=94 participants at risk Dysport® administered in either first intervention period or second intervention period	Botox® (onabotulinumtoxinA) n=94 participants at risk Botox® administered in either first intervention period or second intervention period
Musculoskeletal and connective tissue disorders Muscle weakness	9.6% 9/94 • Number of events 9 • 4 Months	13.8% 13/94 • Number of events 13 • 4 Months
Musculoskeletal and connective tissue disorders Dysphagia	6.4% 6/94 • Number of events 6 • 4 Months	12.8% 12/94 • Number of events 12 • 4 Months
Musculoskeletal and connective tissue disorders Pain on neck and shoulder	2.1% 2/94 • Number of events 2 • 4 Months	7.4% 7/94 • Number of events 7 • 4 Months

Additional Information

BS Jeon

Seoul National University Hospital

Phone: +82220722876

Email: brain@snu.ac.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place