Botulinum ToxinPhase 4NCT01664013
The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients
A Phase 4 study testing Nuronox in people with Botulinum Toxin and Quality of Life, run by Roongroj Bhidayasiri at 1 site in Thailand.
Trial summary
The purpose of this study is to investigate the impact of botulinum toxin treatment in quality of life(QoL) in cervical dystonia patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Botulinum Toxin, Quality of Life, Cervical Dystonia
- What is being tested?
- Nuronox
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2012to Oct 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Roongroj Bhidayasiri
Pathumwan, Bangkok, 10330
Roongroj Bhidayasiri, MD, +662 2564630, rbh1@ucla.du
Roongroj Bhidayasiri, MD
About this study
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
- Being tested
- Nuronox
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuronoxDrug
Also called Clostridium Botulinum Toxin A
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nuronox |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (2)
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).
Measured: 6 weeks
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Botulinum ToxinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roongroj Bhidayasiri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Roongroj Bhidayasiri, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01664013
- Sponsor's protocol ID
- MT_IT_010
- Status last verified
- Aug 2013
- First submitted
- 7 Aug 2012
- Last updated
- 20 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients
- ClinicalTrials.gov ID
- NCT01664013
- Acronym / sponsor ID
- MT_IT_010
- Conditions
- Botulinum Toxin, Quality of Life, Cervical Dystonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Roongroj BhidayasiriUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (estimated)
- First posted
- 14 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the impact of botulinum toxin treatment in quality of life(QoL) in cervical dystonia patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuronox | Experimental | Drug: NuronoxNeuronox® 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NuronoxAlso: Clostridium Botulinum Toxin AReconstituted 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. | Drug | Neuronox |
Primary outcome
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.
2 secondary outcomes
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 symptom after botulinum toxin treatment measured by TWSTRS score
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nuronox in people with Botulinum Toxin and Quality of Life, run by Roongroj Bhidayasiri at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roongroj Bhidayasiri, MD (+662 2564630, rbh1@ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the change of quality of life of cervical dystonia patients after botulinum toxin treatment measured by CDQ-24. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2013.