Efficacy and Safety of MEDITOXIN® in Cervical Dystonia (CD Phase III)

April 5, 2019 updated by: Medy-Tox

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Meditoxin
Meditoxin administered 200U~300U, single-dose administration.
Biological: Medytoxin
Intramuscular injection up to 300U.
Other Names:
  • botulinum type A toxin
Active Comparator: Botox
Botox administered 200-300U, single-dose administration.
Biological: Botox
Intramuscular injection up to 300U.
Other Names:
  • botulinum type A toxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: 1, 2, 3 months
Number of adverse events occuring during the clinical trial.
1, 2, 3 months
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.
1, 2, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medy-Tox

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2013

Primary Completion (Actual)

July 30, 2014

Study Completion (Actual)

August 5, 2014

Study Registration Dates

First Submitted

March 27, 2019

First Submitted That Met QC Criteria

April 4, 2019

First Posted (Actual)

April 5, 2019

Study Record Updates

Last Update Posted (Actual)

April 8, 2019

Last Update Submitted That Met QC Criteria

April 5, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT_PRT_CD01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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