Efficacy and Safety of MEDITOXIN® in Cervical Dystonia

Phase 3

Completed

• Conditions: Cervical Dystonia
• Interventions: Biological: Botox; Biological: Medytoxin

• Registration Number: NCT03905304
• Lead Sponsor: Medy-Tox

Brief Summary

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

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 Timeline

• Study Start: 2013-01-09
• Primary Completion: 2014-07-30
• Study Completion: 2014-08-05
• Study First Submitted: 2019-03-27
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-04
• Study First Posted: 2019-04-05
• Last Update Submitted: 2019-04-05
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botox	Botox	Botox administered 200-300U, single-dose administration.
Meditoxin	Medytoxin	Meditoxin administered 200U\~300U, single-dose administration.

Primary Outcome Measures

Name	Time	Method
Change in TWSTRS score	1 month	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.

Secondary Outcome Measures

Name	Time	Method
Change in TWSTRS score	1, 2, 3 months	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.
Safety Analysis of Investigational Product: Number of adverse events occuring during the clinical trial	1, 2, 3 months	Number of adverse events occuring during the clinical trial.