Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia

Phase 1

Completed

• Conditions: Cervical Dystonia
• Interventions: Drug: Botulinum Toxin Type A Injection [Botox]; Drug: Botulinum toxin type A injection

• Registration Number: NCT04171258
• Lead Sponsor: Hugel

Brief Summary

To determine the efficacy and safety of Botulax® in treatment of cervical dystonia

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-20
• Study First Submitted QC: 2019-11-18
• Study First Posted: 2019-11-20
• Study Start: 2020-05-26
• Primary Completion: 2021-04-26
• Study Completion: 2021-10-26
• Status Verified: 2021-11
• Last Update Submitted: 2022-04-14
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botox®	Botulinum Toxin Type A Injection [Botox]	-
Botulax®	Botulinum toxin type A injection	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hugel; 🇰🇷 Seoul, Korea, Republic of