Comparison of Korean Botulinum Toxin Type A Versus Botox in the Treatment of Essential Blepharospasm
Status:
Completed
Trial end date:
2006-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Pacific Pharmaceuticals
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA