The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients
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|ClinicalTrials.gov Identifier: NCT01664013|
Recruitment Status : Unknown
Verified August 2013 by Roongroj Bhidayasiri, Chulalongkorn University.
Recruitment status was: Recruiting
First Posted : August 14, 2012
Last Update Posted : August 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Botulinum Toxin Quality of Life Cervical Dystonia||Drug: Nuronox||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||October 2013|
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
- To investigate the change of quality of life of cervical dystonia patients after botulinum toxin treatment measured by CDQ-24. [ Time Frame: 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.
- To investigate the change of QoL of cervical dystonia patientsafter botulinum toxin treatment measured by SF-36 (Thai version) [ Time Frame: 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 [ Time Frame: 6 weeks ]To Investigate the change of symptom at 6weeks after botulinum toxin treatment from baseline measured by TWSTRS score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|