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

NCT ID: NCT01664013

Last Updated: 2013-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Brief Summary

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The purpose of this study is to investigate the impact of botulinum toxin treatment in quality of life(QoL) in cervical dystonia patients

Detailed Description

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Conditions

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Botulinum Toxin Quality of Life Cervical Dystonia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Nuronox

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Clostridium Botulinum Toxin A

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roongroj Bhidayasiri

OTHER

Sponsor Role lead

Responsible Party

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Roongroj Bhidayasiri

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Roongroj Bhidayasiri

Pathumwan, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Roongroj Bhidayasiri, MD

Role: CONTACT

Phone: +662 2564630

Email: [email protected]

Facility Contacts

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Roongroj Bhidayasiri, MD

Role: primary

Other Identifiers

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MT_IT_010

Identifier Type: -

Identifier Source: org_study_id