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

April 14, 2022 updated by: Hugel

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Botox®
Drug: Botulinum Toxin Type A Injection [Botox]
Active Comparator
Other Names:
  • Botox®
EXPERIMENTAL: Botulax®
Drug: Botulinum toxin type A injection
Experimental
Other Names:
  • Botulax®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of adverse event
Time Frame: 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.
12 weeks (during the clinical trial)
Change From Baseline in the Total Score of the TWSTRS score.
Time Frame: 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.
Baseline to Week 4 , Week 8, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hugel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 26, 2020

Primary Completion (ACTUAL)

April 26, 2021

Study Completion (ACTUAL)

October 26, 2021

Study Registration Dates

First Submitted

June 20, 2019

First Submitted That Met QC Criteria

November 18, 2019

First Posted (ACTUAL)

November 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 14, 2022

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HG-BOTCD-PI-01

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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