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Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia

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ClinicalTrials.gov Identifier: NCT00447772
Recruitment Status : Completed
First Posted : March 15, 2007
Results First Posted : July 30, 2018
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date  ICMJE March 13, 2007
First Posted Date  ICMJE March 15, 2007
Results First Submitted Date  ICMJE May 9, 2017
Results First Posted Date  ICMJE July 30, 2018
Last Update Posted Date January 14, 2019
Study Start Date  ICMJE October 2004
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2017)
Change From Baseline in the Total Score of the Tsui Rating Scale (Patient in Sitting Position) at the First On-treatment Visit (Week 4 or Week 12) [ Time Frame: Baseline to Week 4 or Week 12 (up to 12 weeks) ]
The Tsui rating scale measures severity and duration of head deviation, shoulder elevation and head tremor. This instrument is based on 4 subscores:
  • Subscore A: amplitude of rotation, deflection (tilt) and ante- / retrocollis (range: 0-9 points)
  • Subscore B: duration of movement (values 1 or 2)
  • Subscore C: severity and duration of shoulder elevation (range: 0-3 points)
  • Subscore D: severity and duration of tremor (range: 0-4 points).
The total score was calculated as follows: total score = subscores (A x B) + C + D. The total score ranges between 0 and 25 points. A high total score represents severe CD. The mean change in the total score of the Tsui rating scale (patient in the sitting position) between baseline (Week 0 visit) and the first on-treatment visit (Week 4 or Week 12 visit) is presented.
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2007)
Change in Tsui score in week 4 versus baseline in week 0
Change History Complete list of historical versions of study NCT00447772 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2017)
  • Change in the Total Score of the Tsui Rating Scale (Patient in Sitting Position) Between Visit 1 (Week 0) and Visit 3 (Week 12) [ Time Frame: Baseline to Week 12 ]
    The Tsui rating scale measures severity and duration of head deviation, shoulder elevation and head tremor. This instrument is based on 4 subscores:
    • Subscore A: amplitude of rotation, deflection (tilt) and ante- / retrocollis (range: 0-9 points)
    • Subscore B: duration of movement (values 1 or 2)
    • Subscore C: severity and duration of shoulder elevation (range: 0-3 points)
    • Subscore D: severity and duration of tremor (range: 0-4 points).
    The total score was calculated as follows: total score = subscores (A x B) + C + D. The total score ranges between 0 and 25 points. A high total score represents severe CD. The mean change in the total score of the Tsui rating scale (patient in the sitting position) between baseline (Week 0 visit) and the Week 12 visit is presented.
  • Change in the Total Score of the Tsui Rating Scale (Patient Walking) Between Baseline (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12) [ Time Frame: Baseline to Week 4 and Week 12 ]
    The Tsui rating scale measures severity and duration of head deviation, shoulder elevation and head tremor. This instrument is based on 4 subscores:
    • Subscore A: amplitude of rotation, deflection (tilt) and ante- / retrocollis (range: 0-9 points)
    • Subscore B: duration of movement (values 1 or 2)
    • Subscore C: severity and duration of shoulder elevation (range: 0-3 points)
    • Subscore D: severity and duration of tremor (range: 0-4 points).
    The total score was calculated as follows: total score = subscores (A x B) + C + D. The total score ranges between 0 and 25 points. A high total score represents severe CD. The mean changes in the total score of the Tsui rating scale (patient walking) between baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented.
  • Change in the 4 Subscores of the Tsui Rating Scale (Patient in the Sitting Position) Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12) [ Time Frame: Baseline to Week 4 and Week 12 ]
    The Tsui rating scale measures severity and duration of head deviation, shoulder elevation and head tremor. This instrument is based on 4 subscores:
    • Subscore A: amplitude of rotation, deflection (tilt) and ante- / retrocollis (range: 0-9 points)
    • Subscore B: duration of movement (values 1 or 2)
    • Subscore C: severity and duration of shoulder elevation (range: 0-3 points)
    • Subscore D: severity and duration of tremor (range: 0-4 points).
    A higher score for each subscale represents severe CD symptoms. The total score was calculated as follows: total score = subscores (A x B) + C + D. The total score ranges between 0 and 25 points. A high total score represents severe CD. The mean changes in the subscores A to D of the Tsui rating scale (patient in the sitting position) between baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented.
  • Change in the Craniocervical Dystonia Questionnaire (CDQ-24) Total Score and Subscores Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12) [ Time Frame: Baseline to Week 4 and Week 12 ]
    The CDQ-24 is a disease-specific quality of life (QoL) instrument and was assessed at Visits 1 to 3. It consists of 24 items investigating problems in daily living skills related to CD. This instrument is based on 5 subscales: Stigma, Emotional well-being, Pain, Activities of daily living (ADL), Social/family life to which a number of the 24 items are assigned. There are five possible answers to each item representing increasing severity of impairment (scores 0 to 4). The total scores ranged from 0 to 96 (best to worst QoL). In order to obtain scores of the individual subscales, the total score of each subscale (sum of the individual item scores) was transformed linearly to a 0 to 100 scale (best to worst QoL). The mean changes in the CDQ-24 total score between baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented.
  • Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12) [ Time Frame: Baseline to Week 4 and Week 12 ]
    The weekly recorded patient diary consists of the three items: Day-to-Day Capacities and Activities, Pain and Duration of Pain. Each item was rated by the patient on an 11-point scale ranging from 0 = no problems at all to 10 = most severe problems (the actual wording is adapted to each item in question). The mean changes between the baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented.
  • Categorical Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12) [ Time Frame: Baseline to Week 4 and Week 12 ]
    The weekly recorded patient diary consists of the three items: Day-to-Day Capacities and Activities, Pain and Duration of Pain. Each item was rated by the patient on an 11-point scale ranging from 0 = no problems at all to 10 = most severe problems (the actual wording is adapted to each item in question). The following categorical changes between the baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented: Improvement, No change and Deterioration.
  • Number of Patients Without Pain and/or With a Reduction in Pain Based on a Global Assessment of Pain by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12) [ Time Frame: Week 4 visit and Week 12 visit ]
    Global pain was assessed at Visit 2 (Week 4) and Visit 3 (Week 12); investigators and patients assessed change in global pain according to the following response categories:
    1. = no pain (anymore)
    2. = less pain
    3. = no change
    4. = more pain
    The numbers of patients falling under each of these categories as assessed by the investigator and patient at Weeks 4 and 12 are presented.
  • Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12) [ Time Frame: Week 4 and Week 12 ]
    At Visit 2 (Week 4) and Visit 3 (Week 12) investigators and patients assessed global efficacy of injection of 500 U Dysport® according to the following response categories:
    1. = very good
    2. = good
    3. = moderate
    4. = insufficient
    The numbers of patients falling under each of these categories as assessed by the investigator and patient at Weeks 4 and 12 are presented.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2007)
  • Recording of quality of life in week 0, 4, 12 (disease specific quality of life questionnaire)
  • Evaluation of efficacy and safety/tolerability by investigator and patient
  • Documentation of the dose and of the injection protocol for any subsequent injections
  • Descriptive analysis of subgroups
  • Tsui score profile over weeks 0, 4 and 12 (while patient is sitting)
  • Optional: additional determination of Tsui score (while patient is walking)
  • Comparison of Tsui scores with patient sitting and patient walking
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia
Official Title  ICMJE Open Multicentre Study to Demonstrate the Efficacy and Safety of Botulinum Toxin A (500 Units Dysport®) in the Treatment of Heterogeneous Forms of Cervical Dystonia
Brief Summary The aim is to demonstrate equivalent efficacy and safety in the treatment of the two most frequent forms of cervical dystonia (predominantly rotational torticollis and predominantly laterocollis) with the standard initial dose of 500 units Dysport®. The patients will be assigned to one of the two basic types of cervical dystonia, either predominantly rotational torticollis or predominantly laterocollis on the basis of clinical examination. This will determine which therapy is to be administered, using the clearly defined, structured injection protocols.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Dystonia
Intervention  ICMJE Drug: Botulinum type A toxin (Dysport®)
Active Drug: Botulinum type A toxin (Dysport®) 500 Units / 2.5 ml injected in muscles involved in cervical dystonia
Other Name: AbobotulinumtoxinA (non-proprietary name)
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Botulinum type A toxin (Dysport®)
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: July 23, 2009)
516
Original Enrollment  ICMJE
 (submitted: March 13, 2007)
600
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • De novo patients with cervical dystonia
  • Outpatient
  • Patients to be of age 18 years or older
  • Written informed consent to participate in the study

Exclusion Criteria:

  • Pre-treatment of cervical dystonia with botulinum toxin
  • Pre-treatment with botulinum toxin for any indication other than cervical dystonia within the past 12 months
  • Pure retro- or antecollis
  • Neurological or other diseases which may affect head and neck motor function or neuromuscular transmission, e.g. polyneuropathy with pareses, myasthenia, myopathy, motor neurone diseases, Bekhterev's disease
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 Austria,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00447772
Other Study ID Numbers  ICMJE A-94-52120-098
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 January 2019

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