Back to resultsClinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia
Primary Purpose
Cervical Dystonia
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Botulinum toxin type A injection
Botulinum Toxin Type A Injection [Botox]
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Dystonia
Eligibility Criteria
Inclusion Criteria:
- Male or female of aged over 19 years
- Subjects diagnosed with primary cervical dystonia
Exclusion Criteria:
- Subjects who have administered botulinum toxin within 16 weeks at the time of baseline
- Pregnant or nursing
- Females or males who do not agree on proper contraceptive measure
Sites / Locations
- Hugel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Botulax®
Botox®
Arm Description
Outcomes
Primary Outcome Measures
rate of adverse event
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04171258
Brief Title
Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 26, 2020 (Actual)
Primary Completion Date
April 26, 2021 (Actual)
Study Completion Date
October 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hugel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the efficacy and safety of Botulax® in treatment of cervical dystonia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dystonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Botulax®
Arm Type
Experimental
Arm Title
Botox®
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A injection
Other Intervention Name(s)
Botulax®
Intervention Description
Experimental
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A Injection [Botox]
Other Intervention Name(s)
Botox®
Intervention Description
Active Comparator
Primary Outcome Measure Information:
Title
rate of adverse event
Description
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)
Title
Change From Baseline in the Total Score of the TWSTRS score.
Description
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.
Time Frame
Baseline to Week 4 , Week 8, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female of aged over 19 years
Subjects diagnosed with primary cervical dystonia
Exclusion Criteria:
Subjects who have administered botulinum toxin within 16 weeks at the time of baseline
Pregnant or nursing
Females or males who do not agree on proper contraceptive measure
Facility Information:
Facility Name
Hugel
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia
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