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

This study has been completed.
Sponsor:
Collaborators:
Ipsen
Medical Research Collaborating Center, Seoul, Korea
Information provided by (Responsible Party):
BS Jeon, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00950664
First received: July 29, 2009
Last updated: August 5, 2013
Last verified: August 2013
  Purpose
  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

Condition Intervention Phase
Cervical Dystonia
Drug: Dysport® (abobotulinumtoxinA)
Drug: Botox® (onabotulinumtoxinA)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized, Multi-center, Cross-over Study to Demonstrate the Non-inferiority of Dysport® (abobotulinumtoxinA) in the Clinical Efficacy and Safety in Comparison With Botox®(onabotulinumtoxinA), Assuming a Bioequivalence Ratio of 2.5:1 Units, in the Treatment of Cervical Dystonia

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Reduction of Total Tsui Score at 4 Weeks From Baseline [ Time Frame: 4 weeks after injection from baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 weeks after injection from baseline ] [ Designated as safety issue: No ]
    TWSTRS (Toronto western spasmodic torticollis rating scale) (range: 0-80, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of TWSTRS.

  • CGI-I (Clinical Global Impression of Illness) [ Time Frame: 4, 8, 12 and 16 weeks after injection ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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



Other Outcome Measures:
  • Reduction of Tsui Score at Each Visit From Baseline [ Time Frame: 4, 8, 12 and 16 weeks after injection ] [ Designated as safety issue: No ]
    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: 4, 8, 12 and 16 weeks after injection ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Pain subscale of TWSTRS scale.(Range: 0-20) Negative numbers to represent decreases of TWSTRS pain subscale.


Enrollment: 103
Study Start Date: August 2009
Study Completion Date: July 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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: 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 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

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.
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950664

Locations
Korea, Republic of
Bundang Seoul Natiuonal University Hospital
Seongnam, Gyeong-gi, Korea, Republic of, 463-070
Dong-A University Hospital
Busan, Korea, Republic of, 602-715
Hanyang University Hospital
Seoul, Korea, Republic of, 133-792
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Boramae City Hospital
Seoul, Korea, Republic of, 156-707
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Ipsen
Medical Research Collaborating Center, Seoul, Korea
Investigators
Principal Investigator: Beom S Jeon, MD, PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: BS Jeon, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00950664     History of Changes
Other Study ID Numbers: H-0902-049-272
Study First Received: July 29, 2009
Results First Received: February 8, 2013
Last Updated: August 5, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
cervical dystonia
botulinum toxin

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014