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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01664013

Enrollment

Registered

2012-08-14

Start date

2012-10-31

Completion date

Unknown

Last updated

2013-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Botulinum Toxin, Cervical Dystonia, Quality of Life

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

Interventions

DRUGNuronox

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
To investigate the change of quality of life of cervical dystonia patients after botulinum toxin treatment measured by CDQ-24.	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

Measure	Time frame	Description
To investigate the change of QoL of cervical dystonia patientsafter botulinum toxin treatment measured by SF-36 (Thai version)	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).
To Investigate the change of symptom after botulinum toxin treatment measured by TWSTRS score	6 weeks	To Investigate the change of symptom at 6weeks after botulinum toxin treatment from baseline measured by TWSTRS score

Countries

Thailand

Contacts

Primary ContactRoongroj Bhidayasiri, MD

rbh1@ucla.edu+662 2564630

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026