Essential BlepharospasmPhase 3NCT01791881
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Hugeltox Inj." in Essential Blepharospasm
A Phase 3 study testing Hugeltox and Botulinum Toxin Type A(Botox®) in people with Essential Blepharospasm, run by Hugel at 9 sites in South Korea.
Trial summary
To compare the efficacy and safety of Hugel-Tox (Botulinum toxin A, Hugel, Korea) against Botox in the treatment of Essential Blepharospasm and to get a regulatory approval from KFDA Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Essential Blepharospasm
- What is being tested?
- Hugeltox and Botulinum Toxin Type A(Botox®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 9 sitesSouth Korea
- Study dates
- Apr 2008to Jul 2009
- Phase
- Phase 3
- 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
- Adult between ages 18 and 75 years
- All patients, diagnosed of essential blepharospasm, with Grade 2~4 of Severity of Spmasm (by Scott's Method)
Who cannot join
- Patients have undergone surgical surgery to treat blepharospmasm like myectomy or neurectomy
- Patients with hypersensitivity history to botulinum toxin products previously
- Patients with secondary blepharomspasm
- Patients with hemifacialspasm
- Patients with treatment following drugs ; Anticonvulsants, tranquilizers, narcotics, aminoglycoside antibiotics, muscle relaxtants like baclofen etc., blockers of parasympathetic nervous system, levodopa
- Patients with previous injection of other botulinum toxin products in 3 months
- Patients with any other significant neuromuscular disease like Myasthenia gravis
- Pregnant or breastfeeding women
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Cha Hospital
Bundang
Seoul National University Hospital - Bundang
Bundang
Youngnam University Hospital
Daegu
Samsung medical Center
Seoul, Seoul
The Catholic University, Seoul, St.Mary's hospital
Seoul, Seoul
Chungang University Hospital
Seoul
Kim's eye hospital
Seoul
The catholic university, Yeouido, St. Mary's hospital
Seoul
Yeonsei University, Severance hospital - Gangnam
Seoul
About this study
Official title: Double-blinded, Randomized, Active Control Comparative, Parallel-designed, Phase III Clinical Trial: Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Hugeltox Inj." In Essential Blepharospasm Running Parallel With Phase I Study
To compare the efficacy and safety of Hugel-Tox (Botulinum toxin A, Hugel, Korea) against Botox in the treatment of Essential Blepharospasm and to get a regulatory approval from KFDA
- Conditions
- Essential Blepharospasm
- Being tested
- Hugeltox, Botulinum Toxin Type A(Botox®)
- 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.
HugeltoxDrug
1.25U~2.5U/site, Maximum dosage 12.5U~60U/person
Botulinum Toxin Type A(Botox®)Drug
1.25U~2.5U/site, Maximum dosage 12.5U~60U/person
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin type A(Botox®) | Active comparator | Botulinum toxin type A(Botox®) Receives: Drug: Hugeltox; Drug: Botulinum Toxin Type A(Botox®) |
| Botulinum toxin type A(Hugeltox) | Experimental | Botulinum toxin type A(Hugeltox) Receives: Drug: Hugeltox; Drug: Botulinum Toxin Type A(Botox®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with an improvement more than one Grade of Severity of Spasm (by Scott's Method)
Measured: at 4 weeks post-injection
Secondary outcomes (4)
(1) Duration of action days
Measured: 6 months
(2) Grades of Severity of Spasm (by Scott's Method), Functional Visual Status
Measured: at four weeks post-injection
(3) Rate of patients with a Grade-0 or Grade-1 of Severity Spasm (by Scott's Method)
Measured: at four weeks post-injection
(4) Rate of patients with an improvement more than two Grade of Severity of Spasm (by Scott's Method)
Measured: at four 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 posted15 Feb 2013 (estimated)
- Study startApr 2008
- Primary completionMay 2009
- Study completionJul 2009
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoon-Duck Kim, M.D., Ph.D., Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791881
- Sponsor's protocol ID
- HG-06-01
- Status last verified
- Feb 2013
- First submitted
- 13 Feb 2013
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blinded, Randomized, Active Control Comparative, Parallel-designed, Phase III Clinical Trial: Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Hugeltox Inj." In Essential Blepharospasm Running Parallel With Phase I Study
- ClinicalTrials.gov ID
- NCT01791881
- Acronym / sponsor ID
- HG-06-01
- Conditions
- Essential Blepharospasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- HugelIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 15 Feb 2013 (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.
To compare the efficacy and safety of Hugel-Tox (Botulinum toxin A, Hugel, Korea) against Botox in the treatment of Essential Blepharospasm and to get a regulatory approval from KFDA
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin type A(Botox®) | Active comparator | Drug: Hugeltox, Drug: Botulinum Toxin Type A(Botox®)Botulinum toxin type A(Botox®) |
| Botulinum toxin type A(Hugeltox) | Experimental | Drug: Hugeltox, Drug: Botulinum Toxin Type A(Botox®)Botulinum toxin type A(Hugeltox) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult between ages 18 and 75 years
- All patients, diagnosed of essential blepharospasm, with Grade 2~4 of Severity of Spmasm (by Scott's Method)
Key exclusion criteria (8 listed)
- Patients have undergone surgical surgery to treat blepharospmasm like myectomy or neurectomy
- Patients with hypersensitivity history to botulinum toxin products previously
- Patients with secondary blepharomspasm
- Patients with hemifacialspasm
- Patients with treatment following drugs ; Anticonvulsants, tranquilizers, narcotics, aminoglycoside antibiotics, muscle relaxtants like baclofen etc., blockers of parasympathetic nervous system, levodopa
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 |
|---|---|---|
| Hugeltox1.25U~2.5U/site, Maximum dosage 12.5U~60U/person | Drug | Botulinum toxin type A(Botox®), Botulinum toxin type A(Hugeltox) |
| Botulinum Toxin Type A(Botox®)1.25U~2.5U/site, Maximum dosage 12.5U~60U/person | Drug | Botulinum toxin type A(Botox®), Botulinum toxin type A(Hugeltox) |
Primary outcome
Rate of patients with an improvement more than one Grade of Severity of Spasm (by Scott's Method)
Time frame: at 4 weeks post-injection
4 secondary outcomes
(1) Duration of action days
Time frame: 6 months
(2) Grades of Severity of Spasm (by Scott's Method), Functional Visual Status
Time frame: at four weeks post-injection
(3) Rate of patients with a Grade-0 or Grade-1 of Severity Spasm (by Scott's Method)
Time frame: at four weeks post-injection
(4) Rate of patients with an improvement more than two Grade of Severity of Spasm (by Scott's Method)
Time frame: at four 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 15 Feb 2013.
Related trials for Essential Blepharospasm
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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.
Yoon-Duck Kim, M.D., Ph.D. study chair
Samsung Medical Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hugeltox and Botulinum Toxin Type A(Botox®) in people with Essential Blepharospasm, run by Hugel at 9 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 2 inclusion and 8 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 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Rate of patients with an improvement more than one Grade of Severity of Spasm (by Scott's Method) (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 15 Feb 2013.