Status:
COMPLETED
Meditoxin® Treatment in Patients With Cervical Dystonia
Lead Sponsor:
Medy-Tox
Conditions:
Dystonia
Dystonic Disorder
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief Summary
To determine the efficacy and safety of Meditoxin in subjects with cervical dystonia compared with placebo (normal saline)
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2018
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03232320
Start Date
July 6 2017
End Date
November 5 2018
Last Update
March 27 2019
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea