Longitudinal Study for Treatment With Botulinum Toxin A Injections in naïve and Pre-treated Patients Suffering From Cervical Dystonia [CD-NIS-Longterm]
NCT ID: NCT01840462
Last Updated: 2019-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
372 participants
OBSERVATIONAL
2012-07-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Subjects naïve to botulinum toxin A (BoNT-A) treatment
Patients naïve to botulinum toxin A treatment
No interventions assigned to this group
Subjects pre-treated with botulinum toxin A (BoNT-A) injection
Patients pre-treated with botulinum toxin A for at least 2 years.
4 injection cycles, each at 3 to 4 months intervals. Investigators follow their individual injection protocol for the treatment with BoNT-A (modalities of administration in accordance with local Summary of Product Characteristics).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Naïve to botulinum toxin A or pre-treated with botulinum toxin A on a regular basis for at least 2 years prior to inclusion and last injection with Dysport® and last injection between 3 and 6 months prior to inclusion
* With the intention to be treated with Dysport®
Exclusion Criteria
* Participation in an interventional trial
* Suffering from anterocollis or retrocollis as primary component
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Graz, , Austria
Wiesbaden, , Germany
Countries
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Other Identifiers
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A-94-52120-165
Identifier Type: -
Identifier Source: org_study_id
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