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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01664013
• Other study ID #: MT_IT_010
• Status: Recruiting
• Phase: Phase 4
• First received: August 7, 2012
• Last updated: August 18, 2013
• Start date: October 2012

Study information

• Verified date: August 2013
• Source: Chulalongkorn University
• Contact: Roongroj Bhidayasiri, MD
• Phone: +662 2564630
• Email: rbh1[@]ucla.edu
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Botulinum Toxin
• Cervical Dystonia
• Dystonia
• Dystonic Disorders
• Quality of Life
• Torticollis

Intervention

Drug:
• Nuronox
Reconstituted Neuronox® is injected at a dose determined by the physician based upon his/her clinical experience with botulinum toxin.Actual dose and injection site should be adjusted individually considering the muscle mass, degree of spasticity, body weight, and response to any previous botulinum toxin injections.

Locations

Country	Name	City	State
Thailand	Roongroj Bhidayasiri	Pathumwan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Roongroj Bhidayasiri

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the change of quality of life of cervical dystonia patients after botulinum toxin treatment measured by CDQ-24.	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.	6 weeks	No
Secondary	To investigate the change of QoL of cervical dystonia patientsafter botulinum toxin treatment measured by SF-36 (Thai version)	To investigate the change of QoL of cervical dystonia patients at 6weeks after botulinum toxin treatment from baseline measured by SF-36 (Thai version).	6 weeks	No
Secondary	To Investigate the change of symptom after botulinum toxin treatment measured by TWSTRS score	To Investigate the change of symptom at 6weeks after botulinum toxin treatment from baseline measured by TWSTRS score	6 weeks	Yes