- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00682760
Comparison of Korean Botulinum Toxin Type A Versus Botox in the Treatment of Essential Blepharospasm
Double-Blind, Randomized, Phase 3, Comparative Study of a New Botulinum Toxin Type A Versus Botox in the Treatment of Essential Blepharospasm
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 120-752
- Sang Yeul Lee
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Korean botulinum toxin A treatment
|
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.
Other Names:
|
Placebo Comparator: 2
Botox treatment
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
at 4 weeks post-injection
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in eyelid closure force and functional visual status after injection for secondary efficacy outcomes
Time Frame: at 4 weeks post-injection
|
at 4 weeks post-injection
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sang Y Lee, MD, phD, Yonsei University
Publications and helpful links
General 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.
- Yoon 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Eye Diseases
- Eyelid Diseases
- Blepharospasm
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- Meditoxin_Botox
- Meditoxin-05-01
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