The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients
NCT ID: NCT01664013
Last Updated: 2013-08-20
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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UNKNOWN
PHASE4
20 participants
INTERVENTIONAL
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Neuronox
Neuronox® is a botulinum toxin type A (BoNT/A) product developed by Medytox Inc. (Medytox) of Korea. Neuronox® was first approved by the Korean Food and Drug Administration in 2006, and by Thai Food and Drug Administration in 2008.
Nuronox
Reconstituted Neuronox® is injected at a dose determined by the physician based upon his/her clinical experience with botulinum toxin.Actual dose and injection site should be adjusted individually considering the muscle mass, degree of spasticity, body weight, and response to any previous botulinum toxin injections.
Interventions
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Nuronox
Reconstituted Neuronox® is injected at a dose determined by the physician based upon his/her clinical experience with botulinum toxin.Actual dose and injection site should be adjusted individually considering the muscle mass, degree of spasticity, body weight, and response to any previous botulinum toxin injections.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects requiring treatment for a clinical diagnosis of cervical dystonia
* Willing to provide written informed consent before any study-related procedures.
Exclusion Criteria
* Patients with an anaphlyactic response history to botulinum toxin type A.
* Patients who have been treated with botulinum toxin type A within 3 month.
* Females who are pregnant, planning pregnancy, unable to use contraception or lactating.
* Any medical condition that may put the subject at increased risk with exposure to botulinum toxin at the discrimination of investigators.
18 Years
75 Years
ALL
No
Sponsors
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Roongroj Bhidayasiri
OTHER
Responsible Party
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Roongroj Bhidayasiri
Associate Professor
Locations
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Roongroj Bhidayasiri
Pathumwan, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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Roongroj Bhidayasiri, MD
Role: primary
Other Identifiers
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MT_IT_010
Identifier Type: -
Identifier Source: org_study_id