Clinical Trial: Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Hugeltox Inj." in Essential Blepharospasm
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Double-blinded, Randomized, Active Control Comparative, Parallel-designed, Phase III Clinical Trial: Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Hugeltox Inj.&
Brief Summary: To compare the efficacy and safety of Hugel-Tox (Botulinum toxin A, Hugel, Korea) against Botox in the treatment of Essential Blepharospasm and to get a regulatory approval from KFDA
Detailed Summary:
Sponsor: Hugel
Current Primary Outcome: Rate of patients with an improvement more than one Grade of Severity of Spasm (by Scott's Method) [ Time Frame: at 4 weeks post-injection ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- (1) Duration of action days [ Time Frame: 6 months ]
- (2) Grades of Severity of Spasm (by Scott's Method), Functional Visual Status [ Time Frame: at four weeks post-injection ]
- (3) Rate of patients with a Grade-0 or Grade-1 of Severity Spasm (by Scott's Method) [ Time Frame: at four weeks post-injection ]
- (4) Rate of patients with an improvement more than two Grade of Severity of Spasm (by Scott's Method) [ Time Frame: at four weeks post-injection ]
Original Secondary Outcome: Same as current
Information By: Hugel
Dates:
Date Received: February 13, 2013
Date Started: April 2008
Date Completion:
Last Updated: February 13, 2013
Last Verified: February 2013
