Meditoxin® Treatment in Patients With Cervical Dystonia

• Status: Completed
• Trial end date: 2018-11-05
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medy-Tox
• Treatments: Botulinum Toxins, Type A

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