Clinical trial NCT01791881: Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Hugeltox Inj." in Essential Blepharospasm
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." In Essential Blepharospasm Running Parallel With Phase I Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Blepharospasm
Lead sponsor: Hugel
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Rate of patients with an improvement more than one Grade of Severity of Spasm (by Scott's Method)
timeFrame: at 4 weeks post-injection
Secondary outcomes:
measure: (1) Duration of action days
timeFrame: 6 months
measure: (2) Grades of Severity of Spasm (by Scott's Method), Functional Visual Status
timeFrame: at four weeks post-injection
measure: (3) Rate of patients with a Grade-0 or Grade-1 of Severity Spasm (by Scott's Method)
timeFrame: at four weeks post-injection
measure: (4) Rate of patients with an improvement more than two Grade of Severity of Spasm (by Scott's Method)
timeFrame: at four weeks post-injection
Other outcomes:
Locations:
city: Bundang
country: Korea, Republic of
facility: Cha Hospital
city: Bundang
country: Korea, Republic of
facility: Seoul National University Hospital - Bundang
city: Daegu
country: Korea, Republic of
facility: Youngnam University Hospital
city: Seoul
country: Korea, Republic of
facility: Chungang University Hospital
city: Seoul
country: Korea, Republic of
facility: Kim's eye hospital
city: Seoul
country: Korea, Republic of
facility: Samsung medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University, Seoul, St.Mary's hospital
city: Seoul
country: Korea, Republic of
facility: The catholic university, Yeouido, St. Mary's hospital
city: Seoul
country: Korea, Republic of
facility: Yeonsei University, Severance hospital - Gangnam
Study officials:
affiliation: Samsung Medical Center
name: Yoon-Duck Kim, M.D., Ph.D.
role: STUDY_CHAIR
References: