Essential BlepharospasmPhase 4NCT01259557
Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm
A Phase 4 study testing Botulinum Toxin Type A in people with Essential Blepharospasm, run by Medy-Tox at 3 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the treatment of Essential blepharospasm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Blepharospasm
- What is being tested?
- Botulinum Toxin Type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Aug 2010to Aug 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged above 18
- Subjects who was diagnosed with Essential Blepharospasm
- Subjects who voluntarily Signed written informed consent
- Subjects who can adhere to protocol and study requirements
Who cannot join
- Subjects with known history of allergy considered due to Botulinum toxin type A
- Subjects who have received botulinum toxin A type within 3 months
- Any disease that might affect neuromuscular function (e.g.. Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis ect.)
- Subjects who are participating in other clinical trials
- Pregnant or lactating female Subjects
- Subjects who are not eligible for the study at the discretion of the Investigator.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Sevrance Hospital
Seoul, 120-752
Seoul St.Mary Hospital
Seoul, 137-040
Chung-Ang Univesity Yongsan Hospital
Seoul, 140-883
About this study
Official title: Multi-center, Phase Ⅳ, Single Arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Meditoxin® in Subjects With Essential Blepharospasm
The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the treatment of Essential blepharospasm.
- Conditions
- Essential Blepharospasm
- Being tested
- Botulinum Toxin Type A
- Medical subject headings
- Benign essential blepharospasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Meditoxin, Neuronox
2 times, Intra-muscular injection, Maximum dosage total 60U
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin type A(Meditoxin®) | Experimental | Not described Receives: Drug: Botulinum Toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change rate of Jankovic Rating Scale score
To evaluate the change of JRS(Jankovic Rating Scale) score at 4 weeks post treatment based on baseline( 0 week).
Measured: 4weeks
Secondary outcomes (4)
the change rate of Jankovic Rating Scale scale
To evaluate the change of JRS(Jankovic Rating Scale) at retreatment point or 16 weeks post treatment based on Baseline(0 week).
Measured: 0 week, 16weeks(or retreatment point)
the change rate of Blepharospasm Disability Index
To evaluate the change of Blepharospasm Disalbility Index at 4weeks, 8weeks, 16weeks(or retreatment point) post treatment.
Measured: 0week, 4weeks, 8weeks, 16weeks(or retreatment point)
Global assessment about the improvement
To evaluate the Global assessment about the improvement at 4weeks post treatment.
Measured: 4weeks
the duration of efficacy
To evaluate the duration of efficacy
Measured: retreatment point or 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential BlepharospasmStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jaechan Kim, M.D., Ph.D., Principal investigator, Chung-Ang university Yongsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259557
- Sponsor's protocol ID
- MT-PRT-BP02
- Status last verified
- Apr 2012
- First submitted
- 25 Nov 2010
- Last updated
- 25 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Phase Ⅳ, Single Arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Meditoxin® in Subjects With Essential Blepharospasm
- ClinicalTrials.gov ID
- NCT01259557
- Acronym / sponsor ID
- MT-PRT-BP02
- Conditions
- Essential Blepharospasm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 14 Dec 2010 (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 evaluate the efficacy and safety of Meditoxin® in the treatment of Essential blepharospasm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin type A(Meditoxin®) | Experimental | Drug: Botulinum Toxin Type A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged above 18
- Subjects who was diagnosed with Essential Blepharospasm
- Subjects who voluntarily Signed written informed consent
- Subjects who can adhere to protocol and study requirements
Key exclusion criteria (6 listed)
- Subjects with known history of allergy considered due to Botulinum toxin type A
- Subjects who have received botulinum toxin A type within 3 months
- Any disease that might affect neuromuscular function (e.g.. Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis ect.)
- Subjects who are participating in other clinical trials
- Pregnant or lactating female Subjects
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 |
|---|---|---|
| Botulinum Toxin Type AAlso: Meditoxin, Neuronox2 times, Intra-muscular injection, Maximum dosage total 60U | Drug | Botulinum toxin type A(Meditoxin®) |
Primary outcome
the change rate of Jankovic Rating Scale score
Time frame: 4weeks
To evaluate the change of JRS(Jankovic Rating Scale) score at 4 weeks post treatment based on baseline( 0 week).
4 secondary outcomes
the change rate of Jankovic Rating Scale scale
Time frame: 0 week, 16weeks(or retreatment point)
the change rate of Blepharospasm Disability Index
Time frame: 0week, 4weeks, 8weeks, 16weeks(or retreatment point)
Global assessment about the improvement
Time frame: 4weeks
the duration of efficacy
Time frame: retreatment point or 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2012.
Related trials for Essential Blepharospasm
RecruitingPhase 2
DaxibotulinumtoxinA for Blepharospasm
Blepharospasm of Both Eyelids, Blepharospasm of Left Eyelid
RecruitingPhase 4
Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm
Benign Essential Blepharospasm, Hemifacial Spasm
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.
Jaechan Kim, M.D., Ph.D. principal investigator
Chung-Ang university Yongsan Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum Toxin Type A in people with Essential Blepharospasm, run by Medy-Tox at 3 sites in South Korea.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 25 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change rate of Jankovic Rating Scale score (time frame: 4weeks). 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 25 Apr 2012.