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

Primary Purpose

Cervical Dystonia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dysport® (abobotulinumtoxinA)
Botox® (onabotulinumtoxinA)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Dystonia focused on measuring cervical dystonia, botulinum toxin

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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.

Sites / Locations

  • Bundang Seoul Natiuonal University Hospital
  • Dong-A University Hospital
  • Hanyang University Hospital
  • Samsung Medical Center
  • Asan Medical Center
  • Boramae City Hospital
  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dysport® to Botox®

Botox® to Dysport®

Arm Description

Dysport® injection in first intervention period and Botox® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA)

Botox® injection in first intervention period and Dysport® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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'.
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

Full Information

First Posted
July 29, 2009
Last Updated
June 13, 2017
Sponsor
Seoul National University Hospital
Collaborators
Ipsen, Medical Research Collaborating Center, Seoul, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT00950664
Brief Title
A Study to Compare Dysport® and Botox® in the Treatment of Cervical Dystonia
Official Title
A Double Blind, Randomized, Multi-center, Cross-over Study to Demonstrate the Non-inferiority of Dysport® in Comparison With Botox®, Assuming a Bioequivalence Ratio of 2.5:1 Units, in the Cervical Dystonia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Ipsen, Medical Research Collaborating Center, Seoul, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dystonia
Keywords
cervical dystonia, botulinum toxin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dysport® to Botox®
Arm Type
Experimental
Arm Description
Dysport® injection in first intervention period and Botox® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA)
Arm Title
Botox® to Dysport®
Arm Type
Experimental
Arm Description
Botox® injection in first intervention period and Dysport® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA)
Intervention Type
Drug
Intervention Name(s)
Dysport® (abobotulinumtoxinA)
Other Intervention Name(s)
Dysport® (abobotulinumtoxinA)injection
Intervention Description
Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units
Intervention Type
Drug
Intervention Name(s)
Botox® (onabotulinumtoxinA)
Other Intervention Name(s)
Botox® (onabotulinumtoxinA)injection
Intervention Description
Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units
Primary Outcome Measure Information:
Title
Reduction of Total Tsui Score at 4 Weeks From Baseline
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
Secondary Outcome Measure Information:
Title
Reduction of Total TWSTRS Score at 4 Weeks From Baseline
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
Title
CGI-I (Clinical Global Impression of Illness)
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
Title
PGI-I (Patient's Global Impression of Improvement)
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
Other Pre-specified Outcome Measures:
Title
Reduction of Tsui Score at Each Visit From Baseline
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
Title
Reduction of Total TWSTRS at Each Visit From Baseline
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
Title
Reduction of Pain Associated With Cervical Dystonia at Each Visit From Baseline
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beom S Jeon, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bundang Seoul Natiuonal University Hospital
City
Seongnam
State/Province
Gyeong-gi
ZIP/Postal Code
463-070
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Hanyang University Hospital
City
Seoul
ZIP/Postal Code
133-792
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Boramae City Hospital
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25476727
Citation
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.
Results Reference
derived

Learn more about this trial

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

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