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

June 13, 2017 updated by: BS Jeon, Seoul National University Hospital

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

  1. 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.
  2. double blind, randomised, multi center, crossover study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Prospective, randomized, head-to-head, double-blind, cross-over study.
  2. Total patients: A group 51, B group 51
  3. 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)
  4. Compare the TSUI change score from baseline to 4 weeks after injection.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units
Other Names:
  • Dysport® (abobotulinumtoxinA)injection
Drug: Botox® (onabotulinumtoxinA)
Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units
Other Names:
  • Botox® (onabotulinumtoxinA)injection
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)
Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units
Other Names:
  • Dysport® (abobotulinumtoxinA)injection
Drug: Botox® (onabotulinumtoxinA)
Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units
Other Names:
  • Botox® (onabotulinumtoxinA)injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of Total Tsui Score at 4 Weeks From Baseline
Time Frame: 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.
4 weeks after injection from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of Total TWSTRS Score at 4 Weeks From Baseline
Time Frame: 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.
4 weeks after injection from baseline
CGI-I (Clinical Global Impression of Illness)
Time Frame: 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'.
4, 8, 12 and 16 weeks after injection
PGI-I (Patient's Global Impression of Improvement)
Time Frame: 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
4, 8, 12 and 16 weeks after injection

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of Tsui Score at Each Visit From Baseline
Time Frame: 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.
8, 12 and 16 weeks after injection
Reduction of Total TWSTRS at Each Visit From Baseline
Time Frame: 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.
8, 12 and 16 weeks after injection
Reduction of Pain Associated With Cervical Dystonia at Each Visit From Baseline
Time Frame: 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.
4, 8, 12 and 16 weeks after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Ipsen
Medical Research Collaborating Center, Seoul, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

July 29, 2009

First Submitted That Met QC Criteria

July 30, 2009

First Posted (Estimate)

August 3, 2009

Study Record Updates

Last Update Posted (Actual)

July 5, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-0902-049-272

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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