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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 : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Ipsen

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.

Condition or disease Intervention/treatment Phase
Cervical Dystonia Drug: Botulinum type A toxin (Dysport®) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 516 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2004
Actual Primary Completion Date : February 2008
Actual Study Completion Date : April 2008


Arm Intervention/treatment
Experimental: 1 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)




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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.


  6. 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.


  7. 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.


  8. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00447772


  Show 106 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Bert Van Eijk, MD Ipsen

Publications of Results:
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00447772     History of Changes
Other Study ID Numbers: A-94-52120-098
First Posted: March 15, 2007    Key Record Dates
Results First Posted: July 30, 2018
Last Update Posted: July 30, 2018
Last Verified: May 2017

Keywords provided by Ipsen:
Dysport, Cervical Dystonia

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
abobotulinumtoxinA
Botulinum Toxins, Type A
onabotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents