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Completed

NCT Number: NCT04171258

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

Completed

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Key information

Conditions

Cervical Dystonia Dyskinesias Dystonia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Torticollis

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hugel

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin type A injection

Drug

Experimental

Other names: Botulax®

Botulinum Toxin Type A Injection [Botox]

Drug

Active Comparator

Other names: Botox®

Primary outcomes

  1. 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.

  2. 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.

    • severity (0~35 points)
    • pain (0~20 points)
    • disability( 0~30 points) Total score ranges from 0 to 85 points.

Sponsors and collaborators

Lead sponsor

Hugel

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 20, 2019
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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