Back to resultsMeditoxin® Treatment in Patients With Cervical Dystonia
Primary Purpose
Dystonia, Dystonic Disorder
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Meditoxin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dystonia
Eligibility Criteria
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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MEDITOXIN
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
Secondary Outcome Measures
Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a change From Baseline
Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale as a change From Baseline
Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale as a change From Baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03232320
Brief Title
Meditoxin® Treatment in Patients With Cervical Dystonia
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 6, 2017 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
November 5, 2018 (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
5. Study Description
Brief Summary
To determine the efficacy and safety of Meditoxin in subjects with cervical dystonia compared with placebo (normal saline)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystonia, Dystonic Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEDITOXIN
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Meditoxin
Intervention Description
Meditoxin (Botulinum toxin type A)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (Normal saline)
Primary Outcome Measure Information:
Title
Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline
Time Frame
week 4 follow-up visit
Secondary Outcome Measure Information:
Title
Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a change From Baseline
Time Frame
week 4 follow-up visit
Title
Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale as a change From Baseline
Time Frame
week 4 follow-up visit
Title
Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale as a change From Baseline
Time Frame
week 4 follow-up visit
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:
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
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Meditoxin® Treatment in Patients With Cervical Dystonia
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