Efficacy and Safety of MEDITOXIN® in Cervical Dystonia (CD Phase III)
Primary Purpose
Cervical Dystonia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Medytoxin
Botox
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Dystonia focused on measuring CD phase III
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Meditoxin
Botox
Arm Description
Meditoxin administered 200U~300U, single-dose administration.
Botox administered 200-300U, single-dose administration.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Safety Analysis of Investigational Product: Number of adverse events occuring during the clinical trial
Number of adverse events occuring during the clinical trial.
Change in TWSTRS score
Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score after 1, 2, and 3 month of administration. The scale consists scores from 0 to 35 which corresponds to disorder severity, 35 being the most severe.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03905304
Brief Title
Efficacy and Safety of MEDITOXIN® in Cervical Dystonia
Acronym
CD Phase III
Official Title
A Prospective, Randomized, Multi-center, Phase III, Double-Blind, Activi Controlled, Parallel-group Study to Evaliate the Efficacy and Safety of MEDITOXIN® Comparison With BOTOX® in Treatment of Cervical Dystonia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 9, 2013 (Actual)
Primary Completion Date
July 30, 2014 (Actual)
Study Completion Date
August 5, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medy-Tox
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The allocated subject is injected Investigational Product(Meditoxin® or Botox®) 200~300U in cervical muscles. The efficacy and safety are evaluated for 12weeks through 4 follow up visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dystonia
Keywords
CD phase III
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meditoxin
Arm Type
Experimental
Arm Description
Meditoxin administered 200U~300U, single-dose administration.
Arm Title
Botox
Arm Type
Active Comparator
Arm Description
Botox administered 200-300U, single-dose administration.
Intervention Type
Biological
Intervention Name(s)
Medytoxin
Other Intervention Name(s)
botulinum type A toxin
Intervention Description
Intramuscular injection up to 300U.
Intervention Type
Biological
Intervention Name(s)
Botox
Other Intervention Name(s)
botulinum type A toxin
Intervention Description
Intramuscular injection up to 300U.
Primary Outcome Measure Information:
Title
Change in TWSTRS score
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Safety Analysis of Investigational Product: Number of adverse events occuring during the clinical trial
Description
Number of adverse events occuring during the clinical trial.
Time Frame
1, 2, 3 months
Title
Change in TWSTRS score
Description
Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score after 1, 2, and 3 month of administration. The scale consists scores from 0 to 35 which corresponds to disorder severity, 35 being the most severe.
Time Frame
1, 2, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of MEDITOXIN® in Cervical Dystonia
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