Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Hugeltox Inj." in… (NCT01791881) | Clinical Trial Compass
CompletedPhase 3
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Hugeltox Inj." in Essential Blepharospasm
South Korea172 participantsStarted 2008-04
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Rate of patients with an improvement more than one Grade of Severity of Spasm (by Scott's Method)