The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients

Roongroj Bhidayasiri

Status and phase: Unknown; Phase 4

Conditions: Cervical Dystonia; Quality of Life; Botulinum Toxin

Treatments: Drug: Nuronox

Study type: Interventional

Funder types: Other

Identifiers

NCT01664013

MT_IT_010

Details and patient eligibility

About

The purpose of this study is to investigate the impact of botulinum toxin treatment in quality of life(QoL) in cervical dystonia patients

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged ≥ 18 years to 75 years
• Subjects requiring treatment for a clinical diagnosis of cervical dystonia
• Willing to provide written informed consent before any study-related procedures.

Exclusion criteria

• Patients with pure anterocollis
• Patients with an anaphlyactic response history to botulinum toxin type A.
• Patients who have been treated with botulinum toxin type A within 3 month.
• Females who are pregnant, planning pregnancy, unable to use contraception or lactating.
• Any medical condition that may put the subject at increased risk with exposure to botulinum toxin at the discrimination of investigators.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Neuronox

Experimental group

Description:

Neuronox® is a botulinum toxin type A (BoNT/A) product developed by Medytox Inc. (Medytox) of Korea. Neuronox® was first approved by the Korean Food and Drug Administration in 2006, and by Thai Food and Drug Administration in 2008.

Treatment:

Drug: Nuronox