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

Phase 1CompletedNCT04171258

Hugel38 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cervical Dystonia

Interventions

Botulinum toxin type A injectionDRUG

Experimental

Botulinum Toxin Type A Injection [Botox]DRUG

Active Comparator

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hugel

Seoul, South Korea

Outcomes

Primary Outcomes

rate of adverse event

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)

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. 1. severity (0\~35 points) 2. pain (0\~20 points) 3. disability( 0\~30 points) Total score ranges from 0 to 85 points.

Time frame: Baseline to Week 4 , Week 8, Week 12

Data from ClinicalTrials.gov

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