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

Phase 4

• Conditions: Botulinum Toxin; Quality of Life; Cervical Dystonia
• Interventions: Drug: Nuronox

• Registration Number: NCT01664013
• Lead Sponsor: Roongroj Bhidayasiri

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-07
• Study First Submitted QC: 2012-08-13
• Study First Posted: 2012-08-14
• Study Start: 2012-10
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-18
• Last Update Posted: 2013-08-20
• Primary Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neuronox	Nuronox	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.

Primary Outcome Measures

Name	Time	Method
To investigate the change of quality of life of cervical dystonia patients after botulinum toxin treatment measured by CDQ-24.	6 weeks	To investigate the change of quality of life of cervical dystonia patients from baseline at 6 weeks after botulinum toxin treatment measured by CDQ-24.

Secondary Outcome Measures

Name	Time	Method
To investigate the change of QoL of cervical dystonia patientsafter botulinum toxin treatment measured by SF-36 (Thai version)	6 weeks	To investigate the change of QoL of cervical dystonia patients at 6weeks after botulinum toxin treatment from baseline measured by SF-36 (Thai version).
To Investigate the change of symptom after botulinum toxin treatment measured by TWSTRS score	6 weeks	To Investigate the change of symptom at 6weeks after botulinum toxin treatment from baseline measured by TWSTRS score

Trial Locations

Locations (1)

Roongroj Bhidayasiri; 🇹🇭 Pathumwan, Bangkok, Thailand