Efficacy and Safety of MEDITOXIN® in Cervical Dystonia

Last updated: April 5, 2019
Sponsor: Medy-Tox
Overall Status: Completed

Phase

3

Condition

Neck Pain

Dystonias

Dyskinesias

Treatment

N/A

Clinical Study ID

NCT03905304
MT_PRT_CD01
  • Ages 20-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 inTWSTRS.

  • 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

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 acceptablecontraception method

  • Investigator's decision.

Study Design

Total Participants: 152
Study Start date:
January 09, 2013
Estimated Completion Date:
August 05, 2014

Study 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.