Efficacy and Safety of MEDITOXIN® in Cervical Dystonia

NCT03905304 | Completed Phase 3

• 1 other identifier: MT_PRT_CD01
• Study Type: interventional
• Target: 152
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of Cervical Dystonia.

Conditions

Cervical Dystonia

Keywords

CD phase III

Outcome Measures

Primary Outcomes (1)

• Change in TWSTRS score

  Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score after 1 month of administration. The scale consists scores from 0 to 35 which corresponds to disorder severity, 35 being the most severe.

  1 month

Secondary Outcomes (2)

• Safety Analysis of Investigational Product: Number of adverse events occuring during the clinical trial

  1, 2, 3 months

• Change in TWSTRS score

  1, 2, 3 months

Study Arms (2)

Meditoxin

EXPERIMENTAL

Meditoxin administered 200U\~300U, single-dose administration.

Biological: Medytoxin

Botox

ACTIVE COMPARATOR

Botox administered 200-300U, single-dose administration.

Biological: Botox

Interventions

Medytoxin BIOLOGICAL

Intramuscular injection up to 300U.

Also known as: botulinum type A toxin

Meditoxin

Botox BIOLOGICAL

Intramuscular injection up to 300U.

Also known as: botulinum type A toxin

Botox

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged between 20 and 75.
• Patient who is diagnosed with primary cervical dystonia over 1 year.
• Patients whose total score is over 20 in TWSTRS and the severity score is over 10 in TWSTRS.
• For patients with prior treatments of Botox®, over 12 weeks have passed.
• Patients who voluntarily sign the informed consent
• Patients who can comply with the study procedures and visit schedule

You may not qualify if:

• Patient who has been diagnosed with pure anterocollis.
• Patient who has been diagnosed with neuromuscular disorder(myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.)\\
• Severe respiratory function disorder or dysphasia
• Allergy in Investigational Product.
• Pregnant women, breast feeding women and patients disagreeing to use an acceptable contraception method
• Investigator's decision.

Sponsors & Collaborators

• Medy-Tox: lead

MeSH Terms

Conditions

Torticollis

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 5, 2019
• Study Start: January 9, 2013
• Primary Completion: July 30, 2014
• Study Completion: August 5, 2014
• Last Updated: April 8, 2019

Record last verified: 2019-04