Comparison of Korean Botulinum Toxin Type A Versus Botox in the Treatment of Essential Blepharospasm
Information source: Pacific Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Blepharospasm
Intervention: Korean Botulinum toxin type A (KbtxA) and Botox injection (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pacific Pharmaceuticals Official(s) and/or principal investigator(s):
Sang Y Lee, MD, phD, Principal Investigator, Affiliation: Yonsei University College of Medicine
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 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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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
Secondary outcome: Changes in eyelid closure force and functional visual status after injection for secondary efficacy outcomes
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Sang Yeul Lee, Seoul 120-752, Korea, Republic of
Additional Information
Related 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.
Starting date: October 2005
Ending date: August 2006
Last updated: May 21, 2008
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