Clinical Trial: Comparison of Korean Botulinum Toxin Type A Versus Botox in the Treatment of Essential Blepharospasm
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Double-Blind, Randomized, Phase 3, Comparative Study of a New Botulinum Toxin Type A Versus Botox in the Treatment of Essential Blepharospasm
Brief 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.
Detailed Summary:
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.
Sponsor: Pacific Pharmaceuticals
Current 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Changes in eyelid closure force and functional visual status after injection for secondary efficacy outcomes [ Time Frame: at 4 weeks post-injection ]
Original Secondary Outcome: Same as current
Information By: Pacific Pharmaceuticals
Dates:
Date Received: May 20, 2008
Date Started: October 2005
Date Completion:
Last Updated: May 21, 2008
Last Verified: May 2008
