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

Medytox

Status and phase

Completed

Phase 3

Conditions

Cervical Dystonia

Treatments

Biological: Medytoxin

Biological: Botox

Study type

Interventional

Funder types

Industry

Identifiers

NCT03905304

MT_PRT_CD01

Details and patient eligibility

About

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.

Full 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.

Enrollment

152 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No 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.