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OpenTrials
Completed

NCT Number: NCT03905304

Efficacy and Safety of MEDITOXIN® in Cervical Dystonia

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.

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Key information

Conditions

Cervical Dystonia Dyskinesias Dystonia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Torticollis

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medytoxin

Biological

Intramuscular injection up to 300U.

Other names: botulinum type A toxin

BOTOX

Biological

Intramuscular injection up to 300U.

Other names: botulinum type A toxin

Primary outcomes

  1. Change in TWSTRS score

    Time frame: 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 outcomes

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

    Time frame: 1, 2, 3 months

    Number of adverse events occuring during the clinical trial.

  2. Change in TWSTRS score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study title

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

Acronym: CD Phase III

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 5, 2019
Registry last updated
Apr 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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