Essential BlepharospasmPhase 4NCT03641950
The Objective of This Study is to Evaluate the Efficacy and Safety of Botulax® in Patients With Essential Blepharospasm.
A Phase 4 study testing Botulinum toxin type A in people with Essential Blepharospasm, run by Hugel at 1 site in South Korea.
Trial summary
The purpose of this study is evaluate the efficacy and safety of Botulax® 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Apr 2015to 7 Jan 2016
- 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 at the age of 18 or older
- Subjects diagnosed with essential blepharospasm with Jankovic Rating Scale (JRS) frequency and severity sum score ≥2 at screening
- Individuals who agree to participate in the clinical study and voluntarily sign the written informed consent form
- Subjects who are cooperative, have a good understanding of the clinical study, and can comply with study procedures until the end of the study
Who cannot join
- Subjects who had received surgery such as orbicularis oculi resection or facial nerve block for the treatment of the study indication
- Subjects with a history of hypersensitivity reactions to any of the components of the investigational product (botulinum toxins, serum albumin, etc.)
- Subjects with secondary blepharospasm
- Subjects with the hemifacial spasm
- Subjects on treatment with muscle relaxants, benzodiazepines, anticholinergics, or benzamides who had changes in medication within 4 weeks prior to screening or have been on stable medication but are expected to have changes in medication while participating in the study
- Subjects who administered any of the following drugs within 7 days prior to screening: drugs with muscle relaxation activity such as aminoglycoside antibiotics or other antibiotics (spectinomycin HCl, polypeptide antibiotics, tetracycline antibiotics, lincomycin antibiotics)
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- Subjects who administered medications similar to the investigational product (botulinum toxin type A) within 12 weeks
- Subjects with systemic neuromuscular junction disorders: myasthenia gravis, Lambert-Eaton syndrome, or amyotrophic lateral sclerosis
- Pregnant and lactating women
- Women of childbearing potential who are planning to become pregnant within the next 3 months or are not using an appropriate method of contraception (contraceptive methods with an annual failure rate of less than 1% if used properly and continuously, including implant, injection, oral contraceptive, at least one barrier method such as intrauterine device [IUD], hormone IUD, abstinence, or vasectomized partner)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Botulax® in Patients With Essential Blepharospasm
The purpose of this study is evaluate the efficacy and safety of Botulax® in the treatment of Essential blepharospasm.
Read the detailed description
Multi-center, single arm, open-label, Phase IV clinical trial to evaluate the efficacy and safety of Botulax® in Subjects with essential blepharospasm
- Conditions
- Essential Blepharospasm
- Being tested
- Botulinum toxin type A
- Keywords
- Essential Blepharospasm
- 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.
Botulinum toxin type ADrug
Also called Botulax
Recommended initial dose to be intra-muscularly injected to the medial and contralateral pretarsal orbicularis oculi of the upper eyelid and the contralateral pretarsal orbicularis oculi of the lower eyelid is 1.25-2.5U (0.05ml ~ 0.1ml per site).
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin Type A (Botulax) | Experimental | Botulinum Toxin Type A (Botulax) Receives: Drug: Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score change from baseline at 4 weeks post-injection of Jankovic Rating scale
To evaluate the change of JRS (Jankovic Rating scale) score at 4 weeks post treatment based on baseline(0 week).
JRS total score will be calculated as the sum (0~8) of two sub-scores of severity and frequency (0~4 each for severity and frequency) of blepharospasm.
Measured: At 4 weeks post-injection
Secondary outcomes (4)
Total score change from baseline at 16 weeks post-injection of Jankovic Rating scale
To evaluate the change of JRS (Jankovic Rating scale) score at 16 weeks post treatment based on baseline(0 week)
Measured: At 0 weeks and 16 weeks post-injection
Change from baseline at 4 weeks and 16 weeks of Disability Index
To evaluate the change of Blepharospasm Disability Index at 4 weeks and 16 weeks post treatment.
Functional disability assessment scale will be assessed as functional disability score. Functional disability assessment scale consists of 6 daily activities (reading, watching television, household activities (cleaning, etc.), mobility, driving, work).
Measured: At 4 weeks and 16 weeks post-injection
Global Response evaluated by investigator at 4 weeks and 16 weeks after post-injection
To evaluate the Investigator's assessment of global response at Weeks 4 and 16 after treatment.
At Weeks 4 and 16 Visits after treatment, the investigator will assess global response on a 9-point scale from -4 (marked worsening) to +4 (Complete abolition of all signs and symptoms).
Measured: At 4 weeks and 16 weeks post-injection
Change from baseline at 4 weeks and 16 weeks of WHO-Quality of Life(QOL)
To evaluate the change in WHO-Quality of Life (QoL) at Weeks 4 and 16 after treatment from baseline WHOQOL will be assessed by the brief Korean version of WHOQOL (WHOQOL-BREF). The Korean WHOQOL-BREF consists of a total of 26 subscales in 4 domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items). Items in each subscale are in a range from 1 (not at all or very dissatisfied) to 5 (very much or very satisfied).
Measured: At 4 weeks and 16 weeks post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start30 Apr 2015
- Primary completionMay 2015
- Study completion7 Jan 2016
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641950
- Sponsor's protocol ID
- HG-BOT-IV3
- Status last verified
- Mar 2016
- First submitted
- 19 Aug 2018
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Botulax® in Patients With Essential Blepharospasm
- ClinicalTrials.gov ID
- NCT03641950
- Acronym / sponsor ID
- HG-BOT-IV3
- Conditions
- Essential Blepharospasm
- Keywords
- Essential Blepharospasm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- HugelIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2015 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- 7 Jan 2016 (actual)
- First posted
- 22 Aug 2018 (actual)
- 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 evaluate the efficacy and safety of Botulax® in the treatment of Essential blepharospasm.
Detailed description
Multi-center, single arm, open-label, Phase IV clinical trial to evaluate the efficacy and safety of Botulax® in Subjects with essential blepharospasm
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Type A (Botulax) | Experimental | Drug: Botulinum toxin type ABotulinum Toxin Type A (Botulax) |
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 at the age of 18 or older
- Subjects diagnosed with essential blepharospasm with Jankovic Rating Scale (JRS) frequency and severity sum score ≥2 at screening
- Individuals who agree to participate in the clinical study and voluntarily sign the written informed consent form
- Subjects who are cooperative, have a good understanding of the clinical study, and can comply with study procedures until the end of the study
Key exclusion criteria (10 listed)
- Subjects who had received surgery such as orbicularis oculi resection or facial nerve block for the treatment of the study indication
- Subjects with a history of hypersensitivity reactions to any of the components of the investigational product (botulinum toxins, serum albumin, etc.)
- Subjects with secondary blepharospasm
- Subjects with the hemifacial spasm
- Subjects on treatment with muscle relaxants, benzodiazepines, anticholinergics, or benzamides who had changes in medication within 4 weeks prior to screening or have been on stable medication but are expected to have changes in medication while participating in the study
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: BotulaxRecommended initial dose to be intra-muscularly injected to the medial and contralateral pretarsal orbicularis oculi of the upper eyelid and the contralateral pretarsal orbicularis oculi of the lower eyelid is 1.25-2.5U (0.05ml ~ 0.1ml per site). | Drug | Botulinum Toxin Type A (Botulax) |
Primary outcome
Total score change from baseline at 4 weeks post-injection of Jankovic Rating scale
Time frame: At 4 weeks post-injection
To evaluate the change of JRS (Jankovic Rating scale) score at 4 weeks post treatment based on baseline(0 week). JRS total score will be calculated as the sum (0~8) of two sub-scores of severity and frequency (0~4 each for severity and frequency) of blepharospasm.
4 secondary outcomes
Total score change from baseline at 16 weeks post-injection of Jankovic Rating scale
Time frame: At 0 weeks and 16 weeks post-injection
Change from baseline at 4 weeks and 16 weeks of Disability Index
Time frame: At 4 weeks and 16 weeks post-injection
Global Response evaluated by investigator at 4 weeks and 16 weeks after post-injection
Time frame: At 4 weeks and 16 weeks post-injection
Change from baseline at 4 weeks and 16 weeks of WHO-Quality of Life(QOL)
Time frame: At 4 weeks and 16 weeks post-injection
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 22 Aug 2018.
Related trials for Essential Blepharospasm
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Botulinum toxin type A in people with Essential Blepharospasm, run by Hugel at 1 site 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 10 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 22 Aug 2018. 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 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?
Total score change from baseline at 4 weeks post-injection of Jankovic Rating scale (time frame: At 4 weeks post-injection). 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 22 Aug 2018.