Meditoxin® Treatment in Patients With Cervical Dystonia
- Registration Number
- NCT03232320
- Lead Sponsor
- Medy-Tox
- Brief Summary
To determine the efficacy and safety of Meditoxin in subjects with cervical dystonia compared with placebo (normal saline)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - MEDITOXIN Meditoxin -
- Primary Outcome Measures
Name Time Method Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline week 4 follow-up visit
- Secondary Outcome Measures
Name Time Method 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 Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a change From Baseline week 4 follow-up visit
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of