Meditoxin® Treatment in Patients With Cervical Dystonia
NCT ID: NCT03232320
Last Updated: 2019-03-27
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
PHASE3
66 participants
INTERVENTIONAL
2017-07-06
2018-11-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MEDITOXIN
Meditoxin
Meditoxin (Botulinum toxin type A)
Placebo
Placebo
Placebo (Normal saline)
Interventions
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Meditoxin
Meditoxin (Botulinum toxin type A)
Placebo
Placebo (Normal saline)
Eligibility Criteria
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Inclusion Criteria
* Subjects requiring treatment for a clinical diagnosis of cervical dystonia with Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS)-Total Score \>=20 and TWSTRS-Severity score \>=10
Exclusion Criteria
* Subjects with neuromuscular junctional disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome)
* A history of an anaphylactic response to Botulinum toxin type A and other involved ingredients of Investigational product
* Subjects of reproductive age who do not agree to use suitable contraceptive methods for the duration of the study
20 Years
75 Years
ALL
No
Sponsors
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Medy-Tox
INDUSTRY
Responsible Party
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Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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MT01-KR16CVD309
Identifier Type: -
Identifier Source: org_study_id
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