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OpenTrials
Completed

NCT Number: NCT03232320

Meditoxin® Treatment in Patients With Cervical Dystonia

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

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Key information

Conditions

Dystonia Central Nervous System Diseases Dyskinesias Dystonic Disorder Dystonic Disorders Movement Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Meditoxin

Drug

Meditoxin (Botulinum toxin type A)

Placebo

Drug

Placebo (Normal saline)

Primary outcomes

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

    Time frame: week 4 follow-up visit

Secondary outcomes

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

    Time frame: week 4 follow-up visit

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

    Time frame: week 4 follow-up visit

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

    Time frame: week 4 follow-up visit

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 27, 2017
Registry last updated
Mar 27, 2019

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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