Trial | NCT01791881  Report issue

Title

Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Hugeltox Inj." in Essential Blepharospasm
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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    172
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
Study Started
Apr 30
2008
Primary Completion
May 31
2009
Study Completion
Jul 31
2009
Last Update
Feb 15
2013
Estimate

Drug Hugeltox

1.25U~2.5U/site, Maximum dosage 12.5U~60U/person

Drug Botulinum Toxin Type A(Botox®)

1.25U~2.5U/site, Maximum dosage 12.5U~60U/person

Botulinum toxin type A(Botox®) Active Comparator

Botulinum toxin type A(Botox®)

Botulinum toxin type A(Hugeltox) Experimental

Botulinum toxin type A(Hugeltox)

Criteria 

Inclusion Criteria:

Adult between ages 18 and 75 years
All patients, diagnosed of essential blepharospasm, with Grade 2~4 of Severity of Spmasm (by Scott's Method)

Exclusion Criteria:

Patients have undergone surgical surgery to treat blepharospmasm like myectomy or neurectomy
Patients with hypersensitivity history to botulinum toxin products previously
Patients with secondary blepharomspasm
Patients with hemifacialspasm
Patients with treatment following drugs ; Anticonvulsants, tranquilizers, narcotics, aminoglycoside antibiotics, muscle relaxtants like baclofen etc., blockers of parasympathetic nervous system, levodopa
Patients with previous injection of other botulinum toxin products in 3 months
Patients with any other significant neuromuscular disease like Myasthenia gravis
Pregnant or breastfeeding women
No Results Posted