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Open-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia

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ClinicalTrials.gov Identifier: NCT00288509
Recruitment Status : Completed
First Posted : February 8, 2006
Results First Posted : April 2, 2010
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Description
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Brief Summary:
The aim of this study is to assess longer term safety and effectiveness of Dysport®.

Condition or disease Intervention/treatment Phase
Cervical Dystonia Biological: Botulinum toxin type A Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Prospective, Multicenter, Open-label Extension Study to Assess the Longer Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injection in the Treatment of Cervical Dystonia
Study Start Date : February 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Dystonia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dysport
250-1000 units
 Biological: Botulinum toxin type A
In this long-term extension study, a dose of 500 units Dysport was administered by intramuscular injection into the clinically indicated neck muscles in a single dosing session in the first treatment cycle. This was the same dose as given in the preceding study NCT00257660 (Y-47-52120-051). Based on individual safety & efficacy, subjects could then receive up to 3 subsequent injections with doses titrated in 250 unit steps, to a minimum of 250 units and a maximum of 1000 units. Retreatment occurred approximately 12-16 weeks after the previous injection, with the exact timing based on clinical need.
Other Name: AbobotulinumtoxinA (Dysport®)


Outcome Measures
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Primary Outcome Measures :
  1. Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline [ Time Frame: Week 4 follow-up visit ]
    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. For each treatment cycle, the change in TWSTRS total score is the score at week 4 minus the score at baseline.


Secondary Outcome Measures :
  1. Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline [ Time Frame: Week 4 follow-up visit ]
    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 severity is from 0 (absence of severity) to 35 (max severity). For each treatment cycle, the change in TWSTRS severity subscale is the score at week 4 minus the score at baseline.

  2. Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline [ Time Frame: Week 4 follow-up visit ]
    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 disability is from 0 (no disability) to 30 (max disability). For each treatment cycle, the change in TWSTRS disability subscale is the score at week 4 minus the score at baseline.

  3. Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline [ Time Frame: Week 4 follow-up visit ]
    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 pain is from 0 (no pain) to 20 (max pain). For each treatment cycle, the change in TWSTRS pain subscale is the score at week 4 minus the score at baseline.


Eligibility Criteria
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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:

  • Subjects enrolled in the Y-47-52120-051 study, who have completed all study visits up to Week 12, or up to Week 4 in the event of an early withdrawal
  • Returned to pre-treatment status as judged by the Investigator

Exclusion Criteria:

  • Pure anterocollis or pure retrocollis
  • Known antibodies to botulinum toxin type A
  • Requirement for botulinum toxin injections to site(s) other than the neck and unable to avoid such treatment for the duration of the study
  • Known significant underlying swallowing or respiratory abnormality which might be exacerbated by botulinum toxin treatment
Contacts and Locations
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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): NCT00288509


Locations
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Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00288509    
Other Study ID Numbers: Y-47-52120-731
2005-002429-29 ( EudraCT Number )
First Posted: February 8, 2006    Key Record Dates
Results First Posted: April 2, 2010
Last Update Posted: November 22, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
 abobotulinumtoxinA
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