Comparison of Korean Botulinum Toxin Type A Versus Botox in the Treatment of Essential Blepharospasm
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00682760 |
Recruitment Status
:
Completed
First Posted
: May 22, 2008
Last Update Posted
: May 22, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Blepharospasm | Drug: Korean Botulinum toxin type A (KbtxA) and Botox injection | Phase 3 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Double-Blind, Randomized, Phase 3, Comparative Study of a New Botulinum Toxin Type A Versus Botox in the Treatment of Essential Blepharospasm |
Study Start Date : | October 2005 |
Actual Primary Completion Date : | February 2006 |
Actual Study Completion Date : | August 2006 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Korean botulinum toxin A treatment
|
Drug: Korean Botulinum toxin type A (KbtxA) and Botox injection
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 Name: arm1 ; Meditoxin or Neuronox
|
Placebo Comparator: 2
Botox treatment
|
Drug: Korean Botulinum toxin type A (KbtxA) and Botox injection
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 Name: arm1 ; Meditoxin or Neuronox
|
- 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 ]
- Changes in eyelid closure force and functional visual status after injection for secondary efficacy outcomes [ Time Frame: at 4 weeks post-injection ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00682760
Korea, Republic of | |
Sang Yeul Lee | |
Seoul, Korea, Republic of, 120-752 |
Principal Investigator: | Sang Y Lee, MD, phD | Yonsei University |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | KI-YOON, KIM/ CRA of Pacific Pharm, Department of ophthalmology, Yonsei university College of Medicine |
ClinicalTrials.gov Identifier: | NCT00682760 History of Changes |
Other Study ID Numbers: |
Meditoxin_Botox Meditoxin-05-01 |
First Posted: | May 22, 2008 Key Record Dates |
Last Update Posted: | May 22, 2008 |
Last Verified: | May 2008 |
Keywords provided by Pacific Pharmaceuticals:
Botulinum Toxin Type A Blepharospasm |
Additional relevant MeSH terms:
Blepharospasm Eyelid Diseases Eye Diseases Botulinum Toxins onabotulinumtoxinA Botulinum Toxins, Type A abobotulinumtoxinA Acetylcholine Release Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents |