The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients
This study is currently recruiting participants.
Verified August 2013 by Chulalongkorn University
Information provided by (Responsible Party):
Roongroj Bhidayasiri, Chulalongkorn University
First received: August 7, 2012
Last updated: August 18, 2013
Last verified: August 2013
The purpose of this study is to investigate the impact of botulinum toxin treatment in quality of life(QoL) in cervical dystonia patients
Quality of Life
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Chulalongkorn University:
Primary Outcome Measures:
- To investigate the change of quality of life of cervical dystonia patients after botulinum toxin treatment measured by CDQ-24. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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:
- To investigate the change of QoL of cervical dystonia patientsafter botulinum toxin treatment measured by SF-36 (Thai version) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]To Investigate the change of symptom at 6weeks after botulinum toxin treatment from baseline measured by TWSTRS score
|Study Start Date:||October 2012|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
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.
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.
Other Name: Clostridium Botulinum Toxin A
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664013
|Contact: Roongroj Bhidayasiri, MD||+662 firstname.lastname@example.org|
|Pathumwan, Bangkok, Thailand, 10330|
|Contact: Roongroj Bhidayasiri, MD +662 2564630 email@example.com|
|Principal Investigator: Roongroj Bhidayasiri, MD|
Sponsors and Collaborators