A Phase 1 interventional study of Botulinum toxin type A injection and Botulinum Toxin Type A Injection [Botox] in Cervical Dystonia, sponsored by Hugel. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-22.
Sponsored by Hugel · Phase 1, Interventional, and Treatment
To determine the efficacy and safety of Botulax® in treatment of cervical dystonia
Exclusion Criteria:
Drug: Botulinum toxin type A injection
Drug: Botulinum Toxin Type A Injection [Botox]
Experimental
Also known as: Botulax®
Active Comparator
Also known as: Botox®
rate of adverse event
To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after investigational product injection.
Time frame: 12 weeks (during the clinical trial)
Change From Baseline in the Total Score of the TWSTRS score.
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.
Time frame: Baseline to Week 4 , Week 8, Week 12
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Hugel