Who is sponsoring NCT01791881?

NCT01791881 is sponsored by Hugel.

What condition does NCT01791881 study?

NCT01791881 studies Essential Blepharospasm.

What drugs are being tested in NCT01791881?

Interventions: Hugeltox, Botulinum Toxin Type A(Botox®).

What is the status of NCT01791881?

NCT01791881 is currently COMPLETED.

Last reviewed 2013-02-13 · How we verify

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." In Essential Blepharospasm Running Parallel With Phase I Study

NCT01791881 Phase 3 COMPLETED

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

Details

Lead sponsor	Hugel
Phase	Phase 3
Status	COMPLETED
Enrolment	172
Start date	2008-04
Completion	2009-07

Conditions

Essential Blepharospasm

Interventions

Hugeltox
Botulinum Toxin Type A(Botox®)

Primary outcomes

Rate of patients with an improvement more than one Grade of Severity of Spasm (by Scott's Method) — at 4 weeks post-injection

Countries

South Korea