BlepharospasmPhase 3NCT00682760
Comparison of Korean Botulinum Toxin Type A Versus Botox in the Treatment of Essential Blepharospasm
A Phase 3 study testing Korean Botulinum toxin type A (KbtxA) and Botox injection in people with Blepharospasm, run by Pacific Pharmaceuticals at 1 site in South Korea.
Trial summary
To compare the efficacy and safety of Korean botulinum toxin A (KbtxA, Pacific Pharmaceuticals, Korea) against Botox in the treatment of essential blepharospasm, we performed a double-blinded, randomized, comparative trial comparing KbtxA and Botox for treatment of blepharospasm in 60 patients of the intention to… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Blepharospasm
- What is being tested?
- Korean Botulinum toxin type A (KbtxA) and Botox injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2005to Aug 2006
- 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
- All patients, aged between 18 and 75 years old, had confirmed diagnoses of bilateral essential blepharospasm.
- The patients were recruited from two botulinum toxin clinics (Yonsei University and Chung-Ang University, Seoul, Korea) from October 18, 2005 until February 21, 2006.
Who cannot join
- Patients were not eligible for inclusion in the study if they
- had undergone either myectomy or neurectomy
- had received anti-spastic, muscle relaxant medication within 1 month of study entry
- had been injected previously with BTX-A within 3 months of study entry
- had any muscle disorder
- Women with positive urine pregnancy test, or who were pregnant or lactating were also excluded from the study.
- In addition, patients who had shown hypersensitivity to BTX-A previously were not eligible for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-Blind, Randomized, Phase 3, Comparative Study of a New Botulinum Toxin Type A Versus Botox in the Treatment of Essential Blepharospasm
To compare the efficacy and safety of Korean botulinum toxin A (KbtxA, Pacific Pharmaceuticals, Korea) against Botox in the treatment of essential blepharospasm, we performed a double-blinded, randomized, comparative trial comparing KbtxA and Botox for treatment of blepharospasm in 60 patients of the intention to treat population and 52 patients (26 patients from each group) of the per protocol population. The improvement of severity of spasm (SS) at 4 weeks post-injection as a primary efficacy outcome, qualifying non inferiority to the control group, Changes in eyelid closure force (CF) and functional visual status (FVS) after injection for secondary efficacy outcomes, and adverse effects for safety evaluation. Improvement of SS was noted in 90.3% of the KbtxA group and 86.2% of the Botox group. There were no significant differences between treatment groups in the changes of CF and FVS after injection (p>0.05). Adverse effects developed in 16.1% of the KbtxA group and 27.6% of the Botox group, but no serious adverse events were found in either group. KbtxA was not inferior to Botox in treatment efficacy and was clinically safe with no serious adverse effects when used to treat essential blepharospasm.
Read the detailed description
Severity of spasm was graded clinically from grade 0 to 4. Primary efficacy outcome was assessed as the number (%) of patients with improved SS of more than 1 score at 4 weeks post-injection. Secondary efficacy outcome measures included the change in scores from baseline on the SS, closing force of eyelids, and functional visual status at 4 weeks post-injection. The duration of action (days), the time interval between injection and the moment that the patient felt the need for retreatment were also assessed as secondary efficacy outcomes.
The number (%) of patients with improvement of SS (primary efficacy outcome) and the change in scores from baseline at 4 weeks post-injection on the severity of spasm, closing force of eyelids, and functional visual status scores were not different between the KbtxA and Botox groups in the analysis of both the ITT and PP populations. Also, the duration of action was similar following KbtxA and Botox injections (two sample t-test, p=0.835). For the non-inferiority trial on primary efficacy outcome, KbtxA was not inferior to Botox in either the ITT or PP populations, as the lower limit of the 95% confidence interval (-1.76% for ITT, -1.64% for PP) was over the -15% threshold.
- Conditions
- Blepharospasm
- Being tested
- Korean Botulinum toxin type A (KbtxA) and Botox injection
- Keywords
- Botulinum Toxin Type A, Blepharospasm
- Medical subject headings
- Blepharospasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Korean Botulinum toxin type A (KbtxA) and Botox injectionDrug
Also called arm1 ; Meditoxin or Neuronox
Each vial of Botox and KbtxA contained 100 U of BTX-A in a sterile vacuum-derived form without preservatives. Each vial of KbtxA was identical to the placebo (Botox) vial, and all vials were reconstituted with 2.0 mL of 0.9% sterile nonpreserved saline solution to a final dilution of 5 U /0.1 mL. The dose of BTX-A per injection site was 2.5 U to 5 U, and the location, number of injection sites. Using a 30-gauge needle, injections were angled away from the center of lid to reduce the risk of spread into the levator muscle. Injection sites include the upper medial and lateral eyelid margins, lower lateral lid margins, and above the eyebrow.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Korean botulinum toxin A treatment Receives: Drug: Korean Botulinum toxin type A (KbtxA) and Botox injection |
| 2 | Placebo comparator | Botox treatment Receives: Drug: Korean Botulinum toxin type A (KbtxA) and Botox injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvement of severity of spasm at 4 weeks post-injection as a primary efficacy outcome, qualifying non inferiority to the control group
Measured: at 4 weeks post-injection
Secondary outcomes (1)
Changes in eyelid closure force and functional visual status after injection for secondary efficacy outcomes
Measured: at 4 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 May 2008 (estimated)
- Study startOct 2005
- Primary completionFeb 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sang Y Lee, MD, phD, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682760
- Sponsor's protocol ID
- Meditoxin_Botox
- Other IDs
- Meditoxin-05-01
- Status last verified
- May 2008
- First submitted
- 20 May 2008
- Last updated
- 22 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stone AV, Ma J, Whitlock PW, Koman LA, Smith TL, Smith BP, Callahan MF. Effects of Botox and Neuronox on muscle force generation in mice. J Orthop Res. 2007 Dec;25(12):1658-64. doi: 10.1002/jor.20450.
PubMed 17600825Yoon JS, Kim JC, Lee SY. Double-blind, randomized, comparative study of Meditoxin versus Botox in the treatment of essential blepharospasm. Korean J Ophthalmol. 2009 Sep;23(3):137-41. doi: 10.3341/kjo.2009.23.3.137. Epub 2009 Sep 8.
PubMed 19794937
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Phase 3, Comparative Study of a New Botulinum Toxin Type A Versus Botox in the Treatment of Essential Blepharospasm
- ClinicalTrials.gov ID
- NCT00682760
- Acronym / sponsor ID
- Meditoxin_Botox
- Conditions
- Blepharospasm
- Keywords
- Botulinum Toxin Type A, Blepharospasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pacific PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 22 May 2008 (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 Korean botulinum toxin A (KbtxA, Pacific Pharmaceuticals, Korea) against Botox in the treatment of essential blepharospasm, we performed a double-blinded, randomized, comparative trial comparing KbtxA and Botox for treatment of blepharospasm in 60 patients of the intention to treat population and 52 patients (26 patients from each group) of the per protocol population. The improvement of severity of spasm (SS) at 4 weeks post-injection as a primary efficacy outcome, qualifying non inferiority to the control group, Changes in eyelid closure force (CF) and functional visual status (FVS) after injection for secondary efficacy outcomes, and adverse effects for safety evaluation. Improvement of SS was noted in 90.3% of the KbtxA group and 86.2% of the Botox group. There were no significant differences between treatment groups in the changes of CF and FVS after injection (p>0.05). Adverse effects developed in 16.1% of the KbtxA group and 27.6% of the Botox group, but no serious adverse events were found in either group. KbtxA was not inferior to Botox in treatment efficacy and was clinically safe with no serious adverse effects when used to treat essential blepharospasm.
Detailed description
Severity of spasm was graded clinically from grade 0 to 4. Primary efficacy outcome was assessed as the number (%) of patients with improved SS of more than 1 score at 4 weeks post-injection. Secondary efficacy outcome measures included the change in scores from baseline on the SS, closing force of eyelids, and functional visual status at 4 weeks post-injection. The duration of action (days), the time interval between injection and the moment that the patient felt the need for retreatment were also assessed as secondary efficacy outcomes.
The number (%) of patients with improvement of SS (primary efficacy outcome) and the change in scores from baseline at 4 weeks post-injection on the severity of spasm, closing force of eyelids, and functional visual status scores were not different between the KbtxA and Botox groups in the analysis of both the ITT and PP populations. Also, the duration of action was similar following KbtxA and Botox injections (two sample t-test, p=0.835). For the non-inferiority trial on primary efficacy outcome, KbtxA was not inferior to Botox in either the ITT or PP populations, as the lower limit of the 95% confidence interval (-1.76% for ITT, -1.64% for PP) was over the -15% threshold.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Korean Botulinum toxin type A (KbtxA) and Botox injectionKorean botulinum toxin A treatment |
| 2 | Placebo comparator | Drug: Korean Botulinum toxin type A (KbtxA) and Botox injectionBotox treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients, aged between 18 and 75 years old, had confirmed diagnoses of bilateral essential blepharospasm.
- The patients were recruited from two botulinum toxin clinics (Yonsei University and Chung-Ang University, Seoul, Korea) from October 18, 2005 until February 21, 2006.
Key exclusion criteria (7 listed)
- Patients were not eligible for inclusion in the study if they
- Women with positive urine pregnancy test, or who were pregnant or lactating were also excluded from the study.
- In addition, patients who had shown hypersensitivity to BTX-A previously were not eligible for inclusion 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 |
|---|---|---|
| Korean Botulinum toxin type A (KbtxA) and Botox injectionAlso: arm1 ; Meditoxin or NeuronoxEach vial of Botox and KbtxA contained 100 U of BTX-A in a sterile vacuum-derived form without preservatives. Each vial of KbtxA was identical to the placebo (Botox) vial, and all vials were reconstituted with 2.0 mL of 0.9% sterile nonpreserved saline solution to a final dilution of 5 U /0.1 mL. The dose of BTX-A per injection site was 2.5 U to 5 U, and the location, number of injection sites. Using a 30-gauge needle, injections were angled away from the center of lid to reduce the risk of spread into the levator muscle. Injection sites include the upper medial and lateral eyelid margins, lower lateral lid margins, and above the eyebrow. | Drug | 1, 2 |
Primary outcome
The improvement of severity of spasm at 4 weeks post-injection as a primary efficacy outcome, qualifying non inferiority to the control group
Time frame: at 4 weeks post-injection
1 secondary outcome
Changes in eyelid closure force and functional visual status after injection for secondary efficacy outcomes
Time frame: at 4 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 May 2008.
- Background: PubMed 17600825Stone AV, Ma J, Whitlock PW, Koman LA, Smith TL, Smith BP, Callahan MF. Effects of Botox and Neuronox on muscle force generation in mice. J Orthop Res. 2007 Dec;25(12):1658-64. doi: 10.1002/jor.20450.
- Derived from this study: PubMed 19794937Yoon JS, Kim JC, Lee SY. Double-blind, randomized, comparative study of Meditoxin versus Botox in the treatment of essential blepharospasm. Korean J Ophthalmol. 2009 Sep;23(3):137-41. doi: 10.3341/kjo.2009.23.3.137. Epub 2009 Sep 8.
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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.
Sang Y Lee, MD, phD principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Korean Botulinum toxin type A (KbtxA) and Botox injection in people with Blepharospasm, run by Pacific Pharmaceuticals 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 2 inclusion and 7 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 May 2008. 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. Some participants in this study may receive a placebo. 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?
The improvement of severity of spasm at 4 weeks post-injection as a primary efficacy outcome, qualifying non inferiority to the control group (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?
On the ClinicalTrials.gov record for NCT00682760, which also lists 2 linked publications.
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 May 2008.