Efficacy and Safety of MEDITOXIN® in Cervical Dystonia

Study Overview
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Brief Summary
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The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of Cervical Dystonia.

Detailed Description
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The allocated subject is injected Investigational Product(Meditoxin® or Botox®) 200 300U in cervical muscles. The efficacy and safety are evaluated for 12weeks through 4 follow up visits.

Official Title
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A Prospective, Randomized, Multi-center, Phase III, Double-Blind, Activi Controlled, Parallel-group Study to Evaliate the Efficacy and Safety of MEDITOXIN® Comparison With BOTOX® in Treatment of Cervical Dystonia

Conditions
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Cervical Dystonia

Intervention / Treatment
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* Biological: Medytoxin
* Biological: Botox


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged between 20 and 75. Patient who is diagnosed with primary cervical dystonia over 1 year. Patients whose total score is over 20 in TWSTRS and the severity score is over 10 in TWSTRS. For patients with prior treatments of Botox®, over 12 weeks have passed. Patients who voluntarily sign the informed consent Patients who can comply with the study procedures and visit schedule Exclusion Criteria: Patient who has been diagnosed with pure anterocollis. Patient who has been diagnosed with neuromuscular disorder(myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.)\ Severe respiratory function disorder or dysphasia Allergy in Investigational Product. Pregnant women, breast feeding women and patients disagreeing to use an acceptable contraception method Investigator's decision.

Ages Eligible for Study
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Minimum Age: 20 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meditoxin<br>Meditoxin administered 200U 300U, single-dose administration. | Biological: Medytoxin<br>* Intramuscular injection up to 300U.<br>* Other names: botulinum type A toxin;|
| Active Comparator: Botox<br>Botox administered 200-300U, single-dose administration. | Biological: Botox<br>* Intramuscular injection up to 300U.<br>* Other names: botulinum type A toxin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TWSTRS score | Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score after 1 month of administration. The scale consists scores from 0 to 35 which corresponds to disorder severity, 35 being the most severe. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Analysis of Investigational Product: Number of adverse events occuring during the clinical trial | Number of adverse events occuring during the clinical trial. | 1, 2, 3 months | 
| Change in TWSTRS score | Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score after 1, 2, and 3 month of administration. The scale consists scores from 0 to 35 which corresponds to disorder severity, 35 being the most severe. | 1, 2, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CD phase III