The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients

Study Overview
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Brief Summary
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The purpose of this study is to investigate the impact of botulinum toxin treatment in quality of life(QoL) in cervical dystonia patients

Official Title
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The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients

Conditions
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Botulinum Toxin, Quality of Life, Cervical Dystonia

Intervention / Treatment
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* Drug: Nuronox


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged ≥ 18 years to 75 years 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 pure anterocollis 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuronox<br>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. | Drug: Nuronox<br>* 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.<br>* Other names: Clostridium Botulinum Toxin A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the change of quality of life of cervical dystonia patients after botulinum toxin treatment measured by CDQ-24. | To investigate the change of quality of life of cervical dystonia patients from baseline at 6 weeks after botulinum toxin treatment measured by CDQ-24. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the change of QoL of cervical dystonia patientsafter botulinum toxin treatment measured by SF-36 (Thai version) | To investigate the change of QoL of cervical dystonia patients at 6weeks after botulinum toxin treatment from baseline measured by SF-36 (Thai version). | 6 weeks | 
| To Investigate the change of symptom after botulinum toxin treatment measured by TWSTRS score | To Investigate the change of symptom at 6weeks after botulinum toxin treatment from baseline measured by TWSTRS score | 6 weeks |