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

August 18, 2013 updated by: Roongroj Bhidayasiri
The purpose of this study is to investigate the impact of botulinum toxin treatment in quality of life(QoL) in cervical dystonia patients

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Roongroj Bhidayasiri, MD
  • Phone Number: +662 2564630
  • Email: rbh1@ucla.edu

Study Locations

  • Thailand
    • Bangkok
      • Pathumwan, Bangkok, Thailand, 10330
        • Recruiting
        • Roongroj Bhidayasiri
        • Contact:
          • Roongroj Bhidayasiri, MD
          • Phone Number: +662 2564630
          • Email: rbh1@ucla.du
        • Principal Investigator:
          • Roongroj Bhidayasiri, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Clostridium Botulinum Toxin A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 weeks
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roongroj Bhidayasiri

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

October 1, 2013

Study Registration Dates

First Submitted

August 7, 2012

First Submitted That Met QC Criteria

August 13, 2012

First Posted (Estimate)

August 14, 2012

Study Record Updates

Last Update Posted (Estimate)

August 20, 2013

Last Update Submitted That Met QC Criteria

August 18, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT_IT_010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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