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

Essential Blepharospasm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791881
• Other study ID #: HG-06-01
• Status: Completed
• Phase: Phase 3
• First received: February 13, 2013
• Last updated: February 13, 2013
• Start date: April 2008
• Est. completion date: July 2009

Study information

• Verified date: February 2013
• Source: Hugel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: July 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blepharospasm
• Essential Blepharospasm

Intervention

Drug:
• Hugeltox
1.25U~2.5U/site, Maximum dosage 12.5U~60U/person
• Botulinum Toxin Type A(Botox®)
1.25U~2.5U/site, Maximum dosage 12.5U~60U/person

Locations

Country	Name	City	State
Korea, Republic of	Cha Hospital	Bundang
Korea, Republic of	Seoul National University Hospital - Bundang	Bundang
Korea, Republic of	Youngnam University Hospital	Daegu
Korea, Republic of	Chungang University Hospital	Seoul
Korea, Republic of	Kim's eye hospital	Seoul
Korea, Republic of	Samsung medical Center	Seoul
Korea, Republic of	The Catholic University, Seoul, St.Mary's hospital	Seoul
Korea, Republic of	The catholic university, Yeouido, St. Mary's hospital	Seoul
Korea, Republic of	Yeonsei University, Severance hospital - Gangnam	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hugel

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with an improvement more than one Grade of Severity of Spasm (by Scott's Method)		at 4 weeks post-injection	Yes
Secondary	(1) Duration of action days		6 months	Yes
Secondary	(2) Grades of Severity of Spasm (by Scott's Method), Functional Visual Status		at four weeks post-injection	Yes
Secondary	(3) Rate of patients with a Grade-0 or Grade-1 of Severity Spasm (by Scott's Method)		at four weeks post-injection	Yes
Secondary	(4) Rate of patients with an improvement more than two Grade of Severity of Spasm (by Scott's Method)		at four weeks post-injection	Yes