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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Roongroj Bhidayasiri, Chulalongkorn University

Study Description
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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

Condition or disease Intervention/treatment Phase
Botulinum Toxin Quality of Life Cervical Dystonia Drug: Nuronox Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Neuronox
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.
 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.
Other Name: Clostridium Botulinum Toxin A


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Roongroj Bhidayasiri, MD +662 2564630 rbh1@ucla.edu

Locations
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Thailand
Roongroj Bhidayasiri Recruiting
Pathumwan, Bangkok, Thailand, 10330
Contact: Roongroj Bhidayasiri, MD    +662 2564630    rbh1@ucla.du   
Principal Investigator: Roongroj Bhidayasiri, MD         
Sponsors and Collaborators
Roongroj Bhidayasiri
More Information
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Responsible Party: Roongroj Bhidayasiri, Associate Professor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01664013    
Other Study ID Numbers: MT_IT_010
First Posted: August 14, 2012    Key Record Dates
Last Update Posted: August 20, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
 abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents