Text Size

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

This study is currently recruiting participants.
Verified April 2013 by Chulalongkorn University
Sponsor:
Information provided by (Responsible Party):
Roongroj Bhidayasiri, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01664013
First received: August 7, 2012
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  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:

MedlinePlus related topics: Botox Dystonia
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


Estimated Enrollment: 20
Study Start Date: October 2012
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664013

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

Locations
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

No publications provided

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: April 9, 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, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013