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

NCT01664013 | Unknown Phase 4

• 1 other identifier: MT_IT_010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Botulinum Toxin; Quality of Life; Cervical Dystonia

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (2)

• 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 symptom after botulinum toxin treatment measured by TWSTRS score

  6 weeks

Study Arms (1)

Neuronox

EXPERIMENTAL

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

Interventions

Nuronox DRUG

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.

Also known as: Clostridium Botulinum Toxin A

Neuronox

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Roongroj Bhidayasiri: lead

Study Sites (1)

Roongroj Bhidayasiri

Pathumwan, Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Conditions

Torticollis

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Central Study Contacts

Roongroj Bhidayasiri, MD

CONTACT

+662 2564630; rbh1@ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: August 14, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2013
• Last Updated: August 20, 2013

Record last verified: 2013-08

Locations

TH (1)