CompletedNCT00950664Updated Jul 5, 2017Results posted

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

A Phase 4 interventional study of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA) in Cervical Dystonia, sponsored by Seoul National University Hospital. Completed at 7 sites in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-07-05.

Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 103
Allocation: Randomized
Ages: 20 Years to 80 Years
Sex: All

Study summary

to examine the non-inferiority of Dysport in the clinical efficacy and safety in comparison with Botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment of Cervical dystonia.
double blind, randomised, multi center, crossover study

Read the detailed description

Prospective, randomized, head-to-head, double-blind, cross-over study.
Total patients: A group 51, B group 51
Study duration: 16 + 4 + 16 weeks. Eligible patients will be randomised at baseline to receive either Dysport® or Botox® and monitored at weeks 2, 4, 8, 12, 16 weeks. After 4 weeks of wash out period, then the patients get the other treatment (i.e, Patients who have got Dysport will be then administered with Botox)
Compare the TSUI change score from baseline to 4 weeks after injection.

Conditions studied

Cervical Dystonia

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Keywords

cervical dystonia
botulinum toxin

In context

Dystonia

319 studies on the registry are indexed under Dystonia; 56 are open to participants now.

This study's enrollment of 103 is above the median of 32 across 181 interventional studies indexed under Dystonia.

Browse Dystonia studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients ≥ 18 years of age of both genders,
Cervical dystonia
symptoms with a minimum duration of 18 months,
Negative pregnancy test in sexually active women,
Able to participate in the study (understand goals of botulinum toxin A treatment and sign Informed Consent Form).

Exclusion criteria

Exclusion Criteria:

Patient with cervical contractures
Known significant underlying dysphasia
Patients who have received botulinum toxin treatment within the past 4 months.
Contraindication to botulinum toxin treatment
Any disease that might affect neuromuscular function (Myasthenia Gravis, Eaton-Lambert syndrome, ALS ...)
Patients who have received oral anti-spasticity medication, phenol therapy, myotomy or denervation surgery, deep brain stimulation for cervical dystonia,
Patients who required more than 500 units of Dysport or 200 units of Botox.
Any concomitant treatment that could interfere with the action of botulinum toxin,
Subjects having participated within the last 3 months or currently participating in an investigational drug study,
Pregnancy,
Lactation.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 103 participants (actual)

Study arms

Experimental
Dysport® to Botox®
Dysport® injection in first intervention period and Botox® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA)
Drug: Dysport® (abobotulinumtoxinA) · Drug: Botox® (onabotulinumtoxinA)
Experimental
Botox® to Dysport®
Botox® injection in first intervention period and Dysport® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA)
Drug: Dysport® (abobotulinumtoxinA) · Drug: Botox® (onabotulinumtoxinA)

Interventions

DrugDysport® (abobotulinumtoxinA)
Cross over injection of Dysport® (\<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units
Also known as: Dysport® (abobotulinumtoxinA)injection
DrugBotox® (onabotulinumtoxinA)
Cross over injection of Dysport® (\<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units
Also known as: Botox® (onabotulinumtoxinA)injection

What researchers measure

Primary outcomes

Reduction of Total Tsui Score at 4 Weeks 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.
Time frame: 4 weeks after injection from baseline

Secondary outcomes

Reduction of Total TWSTRS Score at 4 Weeks 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.
Time frame: 4 weeks after injection from baseline
CGI-I (Clinical Global Impression of Illness)
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
PGI-I (Patient's Global Impression of Improvement)
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

Other outcomes

Reduction of Tsui Score at Each Visit From Baseline
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
Reduction of Total TWSTRS at Each Visit From Baseline
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
Reduction of Pain Associated With Cervical Dystonia at Each Visit From Baseline
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

Results

Posted Oct 11, 2013

Participant flow

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

First Intervention

Participant flow — First Intervention
Milestone	Dysport® First, Then Botox®	Botox® First, Then Dysport®
Started	49	53
Completed	46	48
Not completed	3	5
Withdrew: Lost to follow-up	1	3
Withdrew: Withdrawal by subject	2	2

Washout Period of 4 Weeks

Participant flow — Washout Period of 4 Weeks
Milestone	Dysport® First, Then Botox®	Botox® First, Then Dysport®
Started	46	48
Completed	46	48
Not completed	0	0

Second Intervention

Participant flow — Second Intervention
Milestone	Dysport® First, Then Botox®	Botox® First, Then Dysport®
Started	46	48
Completed	0	0
Not completed	46	48

Outcome measures

PrimaryReduction of Total Tsui Score at 4 Weeks 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.

Time frame:: 4 weeks after injection from baseline
Reported as:: Mean · units on a scale

Reduction of Total Tsui Score at 4 Weeks From Baseline
units on a scale	Dysport® (abobotulinumtoxinA)	Botox® (onabotulinumtoxinA)
Reduction of Total Tsui Score at 4 Weeks From Baseline	-3.98 ± 3.89	-4.77 ± 4.10

Statistical analysis

Dysport® (abobotulinumtoxinA) vs Botox® (onabotulinumtoxinA) · Paired-t test · p = 0.05

SecondaryReduction of Total TWSTRS Score at 4 Weeks 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.

Time frame:: 4 weeks after injection from baseline
Reported as:: Mean · units on a scale

Reduction of Total TWSTRS Score at 4 Weeks From Baseline
units on a scale	Dysport® (abobotulinumtoxinA)	Botox® (onabotulinumtoxinA)
Reduction of Total TWSTRS Score at 4 Weeks From Baseline	-9.76 ± 10.25	-8.78 ± 10.11

Other pre-specifiedReduction of Tsui Score at Each Visit From Baseline

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
Reported as:: Mean · units on a scale

Reduction of Tsui Score at Each Visit From Baseline
units on a scale	Dysport® (abobotulinumtoxinA)	Botox® (onabotulinumtoxinA)
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

SecondaryCGI-I (Clinical Global Impression of Illness)

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
Reported as:: Number · percentage of participants scoring 1or2

CGI-I (Clinical Global Impression of Illness)
percentage of participants scoring 1or2	Dysport® (abobotulinumtoxinA)	Botox® (onabotulinumtoxinA)
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

SecondaryPGI-I (Patient's Global Impression of Improvement)

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
Reported as:: Number · percentage of patients scoring 1 or 2

PGI-I (Patient's Global Impression of Improvement)
percentage of patients scoring 1 or 2	Dysport® (abobotulinumtoxinA)	Botox® (onabotulinumtoxinA)
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

Other pre-specifiedReduction of Total TWSTRS at Each Visit From Baseline

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
Reported as:: Mean · units on a scale

Reduction of Total TWSTRS at Each Visit From Baseline
units on a scale	Dysport® (abobotulinumtoxinA)	Botox® (onabotulinumtoxinA)
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

Other pre-specifiedReduction of Pain Associated With Cervical Dystonia at Each Visit From Baseline

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
Reported as:: Mean · units on a scale

Reduction of Pain Associated With Cervical Dystonia at Each Visit From Baseline
units on a scale	Dysport® (abobotulinumtoxinA)	Botox® (onabotulinumtoxinA)
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

Adverse events

Collected over 4 Months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Dysport® (abobotulinumtoxinA)	0/94 (0%)	0/94 (0%)	14/94 (14.9%)
Botox® (onabotulinumtoxinA)	0/94 (0%)	0/94 (0%)	19/94 (20.2%)

Most frequent other events

Most frequent other events
Event	Dysport® (abobotulinumtoxinA)	Botox® (onabotulinumtoxinA)
Muscle weaknessMusculoskeletal and connective tissue disorders	9/94	13/94
DysphagiaMusculoskeletal and connective tissue disorders	6/94	12/94
Pain on neck and shoulderMusculoskeletal and connective tissue disorders	2/94	7/94

Baseline characteristics

All analyses were performed on the modified intention-to-treat (mITT) basis, with all subjects included in the two treatment challenges.

Age, Categorical
Age, Categorical(Participants)	Dysport® First, Then Botox®	Botox® First, Then Dysport®	Total
<=18 years	0	0	0
Between 18 and 65 years	38	42	80
>=65 years	8	6	14

Age, Continuous
Age, Continuous(years)	Dysport® First, Then Botox®	Botox® First, Then Dysport®	Total
Mean	53.24 ± 11.44	53.35 ± 10.18	53.29 ± 10.76

Sex: Female, Male
Sex: Female, Male(Participants)	Dysport® First, Then Botox®	Botox® First, Then Dysport®	Total
Female	26	31	57
Male	20	17	37

Region of Enrollment
Region of Enrollment(participants)	Dysport® First, Then Botox®	Botox® First, Then Dysport®	Total
Korea, Republic of	46	48	94

Study locations

7 sites

Bundang Seoul Natiuonal University Hospital
Seongnam, Gyeong-gi 463-070, Korea, Republic of
Dong-A University Hospital
Busan, 602-715, Korea, Republic of
Hanyang University Hospital
Seoul, 133-792, Korea, Republic of
Samsung Medical Center
Seoul, 135-710, Korea, Republic of
Asan Medical Center
Seoul, 138-736, Korea, Republic of
Boramae City Hospital
Seoul, 156-707, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of

References and documents

Publications

Yun JY, Kim JW, Kim HT, Chung SJ, Kim JM, Cho JW, Lee JY, Lee HN, You S, Oh E, Jeong H, Kim YE, Kim HJ, Lee WY, Jeon BS. Dysport and Botox at a ratio of 2.5:1 units in cervical dystonia: a double-blind, randomized study. Mov Disord. 2015 Feb;30(2):206-13. doi: 10.1002/mds.26085. Epub 2014 Dec 5. PubMed 25476727 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00950664
Lead sponsor: Seoul National University Hospital
Collaborators: Ipsen, Medical Research Collaborating Center, Seoul, Korea
Responsible party: BS Jeon (Professor, Seoul National University Hospital) — Principal investigator
First posted: Aug 3, 2009
Start date: Aug 2009
Primary completion: Jan 2011
Completion: Jul 2011
Results posted: Oct 11, 2013
Last update: Jul 5, 2017

Study contacts

Beom S Jeon, MD, PhD

principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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