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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00950664
First Posted: August 3, 2009
Last Update Posted: July 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ipsen
Medical Research Collaborating Center, Seoul, Korea
Information provided by (Responsible Party):
BS Jeon, Seoul National University Hospital
July 29, 2009
August 3, 2009
February 8, 2013
October 11, 2013
July 5, 2017
August 2009
January 2011   (Final data collection date for primary outcome measure)
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.

TSUI score change [ Time Frame: from baseline to 4 weeks after injection. ]
Complete list of historical versions of study NCT00950664 on ClinicalTrials.gov Archive Site
  • 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.

  • 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'.

  • 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

  • pain reduction associated with CD using TWSTRS score, duration of action and the change of signs and symptoms of Cervical dystonia. [ Time Frame: 4 weeks after injection ]
  • safety of Dysport® and Botox® [ Time Frame: 4 months after injection ]
  • 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.
  • 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.
  • 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.
Not Provided
 
A Study to Compare Dysport® and Botox® in the Treatment of Cervical Dystonia
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
  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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cervical Dystonia
  • Drug: Dysport® (abobotulinumtoxinA)
    Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units
    Other Name: Dysport® (abobotulinumtoxinA)injection
  • Drug: Botox® (onabotulinumtoxinA)
    Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units
    Other Name: Botox® (onabotulinumtoxinA)injection
  • 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)
    Interventions:
    • 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)
    Interventions:
    • Drug: Dysport® (abobotulinumtoxinA)
    • Drug: Botox® (onabotulinumtoxinA)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
July 2011
January 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00950664
H-0902-049-272
Yes
Not Provided
Plan to Share IPD: No
BS Jeon, Seoul National University Hospital
Seoul National University Hospital
  • Ipsen
  • Medical Research Collaborating Center, Seoul, Korea
Principal Investigator: Beom S Jeon, MD, PhD Seoul National University Hospital
Seoul National University Hospital
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP