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

Cervical Dystonia Clinical Trial

Official title:

A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Phase I Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04171258
• Other study ID #: HG-BOTCD-PI-01
• Status: Completed
• Phase: Phase 1
• Start date: May 26, 2020
• Est. completion date: October 26, 2021

Study information

• Verified date: November 2021
• Source: Hugel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 26, 2021
• Est. primary completion date: April 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Dystonia
• Dystonia
• Dystonic Disorders
• Torticollis

Intervention

Drug:
• Botulinum toxin type A injection
Experimental
• Botulinum Toxin Type A Injection [Botox]
Active Comparator

Locations

Country	Name	City	State
Korea, Republic of	Hugel	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hugel

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of adverse event	To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after investigational product injection.	12 weeks (during the clinical trial)
Primary	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.; severity (0~35 points); pain (0~20 points); disability( 0~30 points) Total score ranges from 0 to 85 points.	Baseline to Week 4 , Week 8, Week 12