Dystonia, Dystonic Disorder
Conditions
Brief summary
To determine the efficacy and safety of Meditoxin in subjects with cervical dystonia compared with placebo (normal saline)
Interventions
DRUGMeditoxin
Meditoxin (Botulinum toxin type A)
DRUGPlacebo
Placebo (Normal saline)
Sponsors
Medy-Tox
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline | week 4 follow-up visit |
Secondary
| Measure | Time frame |
|---|---|
| Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a change From Baseline | week 4 follow-up visit |
| Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale as a change From Baseline | week 4 follow-up visit |
| Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale as a change From Baseline | week 4 follow-up visit |
Countries
South Korea
Outcome results
None listed