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Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia

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ClinicalTrials.gov Identifier: NCT00257660
Recruitment Status : Completed
First Posted : November 23, 2005
Results First Posted : May 10, 2010
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date  ICMJE November 22, 2005
First Posted Date  ICMJE November 23, 2005
Results First Submitted Date  ICMJE January 6, 2010
Results First Posted Date  ICMJE May 10, 2010
Last Update Posted Date November 22, 2019
Study Start Date  ICMJE October 2005
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2010)
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) [ Time Frame: Baseline and Week 4 ]
TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: November 22, 2005)
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - change from baseline at week 4
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2010)
  • Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) [ Time Frame: Baseline and Week 8 ]
    TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
  • Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score [ Time Frame: Baseline and Week 12 ]
    TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
  • Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment [ Time Frame: Baseline and Week 4 ]
    The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
  • Investigator VAS for CD Symptom Assessment [ Time Frame: Baseline and Week 4 ]
    The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
  • Subject VAS for CD Symptom Assessment [ Time Frame: Baseline and Week 8 ]
    The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100mm (worst possible symptoms).
  • Investigator's VAS for CD Symptom Assessment [ Time Frame: Baseline and week 8 ]
    The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
  • Subject VAS for CD Symptom Assessment [ Time Frame: Baseline and week 12 ]
    The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
  • Investigator's VAS for CD Symptom Assessment [ Time Frame: Baseline and week 12 ]
    The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms) to 100 mm (worst possible symptoms).
  • SF-36 Mental Health Summary Score [ Time Frame: Week 8 ]
    SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Mental Health Summary Score is derived from four individual domains (vitality, social functioning, role limitations due to emotional problems and mental health).
  • SF-36 Physical Health Summary Score [ Time Frame: Week 8 ]
    SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Physical Health Summary Score is derived from four individual domains (physical functioning, role physical, bodily pain and general health).
  • Number of Participants Considered by the Investigator to be Overall Treatment Successes [ Time Frame: Week 12 ]
    The number of participants considered to be overall treatment successes by the investigator at week 12 was assessed.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2005)
Subject Visual Analogue Pain Score and Subject Symptom Assessment - change from baseline at week 4
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
Official Title  ICMJE A Phase III Multicentre, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for the Treatment of Cervical Dystonia
Brief Summary The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cervical Dystonia
Intervention  ICMJE
  • Biological: Botulinum toxin type A
    500 units
    Other Name: AbobotulinumtoxinA (Dysport®)
  • Drug: Placebo
    500 units
Study Arms  ICMJE
  • Experimental: 1
    Drug: abobotulinumtoxinA (Dysport®)
    Intervention: Biological: Botulinum toxin type A
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 17, 2008)
116
Original Enrollment  ICMJE
 (submitted: November 22, 2005)
120
Actual Study Completion Date  ICMJE September 2006
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Cervical dystonia with at least 18 months since onset, and previously untreated with botulinum toxin or previously treated with botulinum toxin type A or B with a minimum interval of 16 weeks since the last injection and having returned at least to their usual pre-treatment status
  • TWSTRS severity, disability and total scores meeting the defined criteria at baseline

Exclusion Criteria:

  • Pure anterocollis or pure retrocollis
  • In apparent remission from cervical dystonia
  • Previous poor response to the last two botulinum toxin type A or type B treatments
  • Being treated with type B toxin due to lack of efficacy to type A toxin or have known neutralizing antibodies to type A toxin
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00257660
Other Study ID Numbers  ICMJE Y-47-52120-051
2005-000709-70 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ipsen
Study Sponsor  ICMJE Ipsen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date November 2019

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