Meditoxin® Treatment in Patients With Cervical Dystonia

Medy-Tox66 enrolled

Overview

To determine the efficacy and safety of Meditoxin in subjects with cervical dystonia compared with placebo (normal saline)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dystonia Dystonic Disorder

Interventions

MeditoxinDRUG

Meditoxin (Botulinum toxin type A)

PlaceboDRUG

Placebo (Normal saline)

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female aged 20 to less than 75 years * Subjects requiring treatment for a clinical diagnosis of cervical dystonia with Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS)-Total Score \>=20 and TWSTRS-Severity score \>=10 Exclusion Criteria: * Subjects with pure anterocollis * Subjects with neuromuscular junctional disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome) * A history of an anaphylactic response to Botulinum toxin type A and other involved ingredients of Investigational product * Subjects of reproductive age who do not agree to use suitable contraceptive methods for the duration of the study

Locations (1)

Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline

Time frame: week 4 follow-up visit

Secondary Outcomes

Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a change From Baseline

Time frame: week 4 follow-up visit

Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale as a change From Baseline

Time frame: week 4 follow-up visit

Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale as a change From Baseline

Time frame: week 4 follow-up visit

Data from ClinicalTrials.gov

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