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Clinical 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
Hugel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Dystonia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

First Posted
June 20, 2019
Last Updated
April 14, 2022
Sponsor
Hugel
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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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