Meditoxin® Treatment in Patients With Cervical Dystonia

A Prospective, Randomized, Multi-center, Phase III, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of MEDITOXIN in Treatment of Cervical Dystonia

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

Study Overview

• Status: Completed
• Conditions: Dystonia; Dystonic Disorder
• Intervention / Treatment: Drug: Meditoxin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo (Normal saline)
Experimental: MEDITOXIN	Drug: Meditoxin; Meditoxin (Botulinum toxin type A)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline	week 4 follow-up visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a change From Baseline	week 4 follow-up visit
Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale as a change From Baseline	week 4 follow-up visit
Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale as a change From Baseline	week 4 follow-up visit

Collaborators and Investigators

• Sponsor: Medy-Tox

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2017
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): November 5, 2018

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Dystonia; Dystonic Disorders; Torticollis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A
• Other Study ID Numbers: MT01-KR16CVD309

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No