Efficacy and Safety of MEDITOXIN® in Cervical Dystonia

Cervical Dystonia Clinical Trial

— CD Phase III  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03905304
• Other study ID #: MT_PRT_CD01
• Status: Completed
• Phase: Phase 3
• Start date: January 9, 2013
• Est. completion date: August 5, 2014

Study information

• Verified date: April 2019
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: August 5, 2014
• Est. primary completion date: July 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Dystonia
• Dystonia
• Dystonic Disorders
• Torticollis

Intervention

Biological:
• Medytoxin
Intramuscular injection up to 300U.
• Botox
Intramuscular injection up to 300U.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in TWSTRS score	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	Safety Analysis of Investigational Product: Number of adverse events occuring during the clinical trial	Number of adverse events occuring during the clinical trial.	1, 2, 3 months
Secondary	Change in TWSTRS score	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