Meditoxin® Treatment in Patients With Cervical Dystonia

Dystonia Clinical Trial

Official title:

A Prospective, Randomized, Multi-center, Phase III, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of MEDITOXIN in Treatment of Cervical Dystonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03232320
• Other study ID #: MT01-KR16CVD309
• Status: Completed
• Phase: Phase 3
• Start date: July 6, 2017
• Est. completion date: November 5, 2018

Study information

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

Clinical Trial Summary

To determine the efficacy and safety of Meditoxin in subjects with cervical dystonia compared with placebo (normal saline)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 5, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female aged 20 to less than 75 years

• Subjects requiring treatment for a clinical diagnosis of cervical dystonia with Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS)-Total Score >=20 and TWSTRS-Severity score >=10

Exclusion Criteria:

• Subjects with pure anterocollis

• Subjects with neuromuscular junctional disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome)

• A history of an anaphylactic response to Botulinum toxin type A and other involved ingredients of Investigational product

• Subjects of reproductive age who do not agree to use suitable contraceptive methods for the duration of the study

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorder
• Dystonic Disorders
• Torticollis

Intervention

Drug:
• Meditoxin
Meditoxin (Botulinum toxin type A)
• Placebo
Placebo (Normal saline)

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline		week 4 follow-up visit
Secondary	Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a change From Baseline		week 4 follow-up visit
Secondary	Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale as a change From Baseline		week 4 follow-up visit
Secondary	Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale as a change From Baseline		week 4 follow-up visit