Efficacy and Safety of MEDITOXIN® in Cervical Dystonia

Medy-Tox152 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

152

Conditions

Cervical Dystonia

Interventions

MedytoxinBIOLOGICAL

Intramuscular injection up to 300U.

BotoxBIOLOGICAL

Intramuscular injection up to 300U.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 1 month

Secondary Outcomes

Safety Analysis of Investigational Product: Number of adverse events occuring during the clinical trial

Number of adverse events occuring during the clinical trial.

Time frame: 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.

Time frame: 1, 2, 3 months

Data from ClinicalTrials.gov

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