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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Chulalongkorn University.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Roongroj Bhidayasiri, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01664013
First received: August 7, 2012
Last updated: August 18, 2013
Last verified: August 2013
  Purpose
The purpose of this study is to investigate the impact of botulinum toxin treatment in quality of life(QoL) in cervical dystonia patients

Condition Intervention Phase
Botulinum Toxin
Quality of Life
Cervical Dystonia
Drug: Nuronox
Phase 4

Study Type: Interventional
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:


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


Estimated Enrollment: 20
Study Start Date: October 2012
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01664013

Locations
Thailand
Roongroj Bhidayasiri
Pathumwan, Bangkok, Thailand, 10330
Sponsors and Collaborators
Roongroj Bhidayasiri
  More Information

Responsible Party: Roongroj Bhidayasiri, Associate Professor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01664013     History of Changes
Other Study ID Numbers: MT_IT_010 
Study First Received: August 7, 2012
Last Updated: August 18, 2013
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
onabotulinumtoxinA
incobotulinumtoxinA
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

ClinicalTrials.gov processed this record on December 02, 2016