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
121 studies on the registry are indexed under Torticollis; 18 are open to participants now.
This study's enrollment of 38 is below the median of 50 across 76 interventional studies indexed under Torticollis.
Browse Torticollis studies →Hugel is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Ran from May 2020 to primary completion in Apr 2021, 11 months.
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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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Studies of the drug tested here: Botulinum toxin type A
Hugel