Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm

Medytox

Status and phase: Completed; Phase 4

Conditions: Essential Blepharospasm

Treatments: Drug: Botulinum Toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01259557

MT-PRT-BP02

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the treatment of Essential blepharospasm.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women aged above 18
• Subjects who was diagnosed with Essential Blepharospasm
• Subjects who voluntarily Signed written informed consent
• Subjects who can adhere to protocol and study requirements

Exclusion criteria

• Subjects with known history of allergy considered due to Botulinum toxin type A
• Subjects who have received botulinum toxin A type within 3 months
• Any disease that might affect neuromuscular function (e.g.. Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis ect.)
• Subjects who are participating in other clinical trials
• Pregnant or lactating female Subjects
• Subjects who are not eligible for the study at the discretion of the Investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Botulinum toxin type A(Meditoxin®)

Experimental group

Treatment:

Drug: Botulinum Toxin Type A