Cervical Dystonia
Conditions
Brief summary
To determine the efficacy and safety of Botulax® in treatment of cervical dystonia
Interventions
Experimental
Active Comparator
Sponsors
Hugel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or female of aged over 19 years 2. Subjects diagnosed with primary cervical dystonia
Exclusion criteria
1. Subjects who have administered botulinum toxin within 16 weeks at the time of baseline 2. Pregnant or nursing 3. Females or males who do not agree on proper contraceptive measure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rate of adverse event | 12 weeks (during the clinical trial) | To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after investigational product injection. |
| Change From Baseline in the Total Score of the TWSTRS score. | Baseline to Week 4 , Week 8, Week 12 | The average of the change from baseline in TWSTRS-total score at Weeks 4, 8 and 12 will be determined. full name of TWSTRS is Toronto Western Spasmodic Torticollis Rating Scale. The validated assessment scale TWSTRS is consists of 3 sub-scales. 1. severity (0\ 35 points) 2. pain (0\ 20 points) 3. disability( 0\ 30 points) Total score ranges from 0 to 85 points. |
Countries
South Korea
Outcome results
None listed