Efficacy and Safety of MEDITOXIN® in Cervical Dystonia

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03905304

Acronym

CD Phase III

Enrollment

152

Registered

2019-04-05

Start date

2013-01-09

Completion date

2014-08-05

Last updated

2019-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Dystonia

Keywords

CD phase III

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.

Interventions

BIOLOGICALMedytoxin

Intramuscular injection up to 300U.

BIOLOGICALBotox

Intramuscular injection up to 300U.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026