Meditoxin® Treatment in Patients With Cervical Dystonia

Medytox

Status and phase: Completed; Phase 3

Conditions: Dystonic Disorder; Dystonia

Treatments: Drug: Placebo; Drug: Meditoxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03232320

MT01-KR16CVD309

Details and patient eligibility

About

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

Enrollment: 66 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups, including a placebo group

MEDITOXIN

Experimental group

Treatment:

Drug: Meditoxin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo