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

Primary Purpose

Botulinum Toxin, Quality of Life, Cervical Dystonia

Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Nuronox
Sponsored by
Roongroj Bhidayasiri
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Botulinum Toxin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Roongroj BhidayasiriRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neuronox

Arm Description

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.

Outcomes

Primary Outcome Measures

To investigate the change of quality of life of cervical dystonia patients after botulinum toxin treatment measured by CDQ-24.
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)
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
To Investigate the change of symptom at 6weeks after botulinum toxin treatment from baseline measured by TWSTRS score

Full Information

First Posted
August 7, 2012
Last Updated
August 18, 2013
Sponsor
Roongroj Bhidayasiri
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1. Study Identification

Unique Protocol Identification Number
NCT01664013
Brief Title
The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients
Official Title
The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Roongroj Bhidayasiri

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Botulinum Toxin, Quality of Life, Cervical Dystonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neuronox
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nuronox
Other Intervention Name(s)
Clostridium Botulinum Toxin A
Intervention Description
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.
Primary Outcome Measure Information:
Title
To investigate the change of quality of life of cervical dystonia patients after botulinum toxin treatment measured by CDQ-24.
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
To investigate the change of QoL of cervical dystonia patientsafter botulinum toxin treatment measured by SF-36 (Thai version)
Description
To investigate the change of QoL of cervical dystonia patients at 6weeks after botulinum toxin treatment from baseline measured by SF-36 (Thai version).
Time Frame
6 weeks
Title
To Investigate the change of symptom after botulinum toxin treatment measured by TWSTRS score
Description
To Investigate the change of symptom at 6weeks after botulinum toxin treatment from baseline measured by TWSTRS score
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roongroj Bhidayasiri, MD
Phone
+662 2564630
Email
rbh1@ucla.edu
Facility Information:
Facility Name
Roongroj Bhidayasiri
City
Pathumwan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roongroj Bhidayasiri, MD
Phone
+662 2564630
Email
rbh1@ucla.du
First Name & Middle Initial & Last Name & Degree
Roongroj Bhidayasiri, MD

12. IPD Sharing Statement

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

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