NCT03232320CompletedPhase 3
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
Medy-Tox1 site in 1 country66 target enrollmentStarted: July 6, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
Study Overview
Brief Summary
To determine the efficacy and safety of Meditoxin in subjects with cervical dystonia compared with placebo (normal saline)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
MEDITOXIN
Experimental
Intervention: Meditoxin (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
Time Frame: week 4 follow-up visit
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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