Status:
COMPLETED
Comparison of Korean Botulinum Toxin Type A Versus Botox in the Treatment of Essential Blepharospasm
Lead Sponsor:
Pacific Pharmaceuticals
Conditions:
Blepharospasm
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
To compare the efficacy and safety of Korean botulinum toxin A (KbtxA, Pacific Pharmaceuticals, Korea) against Botox in the treatment of essential blepharospasm, we performed a double-blinded, randomi...
Detailed Description
Severity of spasm was graded clinically from grade 0 to 4. Primary efficacy outcome was assessed as the number (%) of patients with improved SS of more than 1 score at 4 weeks post-injection. Secondar...
Eligibility Criteria
Inclusion
- All patients, aged between 18 and 75 years old, had confirmed diagnoses of bilateral essential blepharospasm.
- The patients were recruited from two botulinum toxin clinics (Yonsei University and Chung-Ang University, Seoul, Korea) from October 18, 2005 until February 21, 2006.
Exclusion
- Patients were not eligible for inclusion in the study if they
- had undergone either myectomy or neurectomy
- had received anti-spastic, muscle relaxant medication within 1 month of study entry
- had been injected previously with BTX-A within 3 months of study entry
- had any muscle disorder
- Women with positive urine pregnancy test, or who were pregnant or lactating were also excluded from the study.
- In addition, patients who had shown hypersensitivity to BTX-A previously were not eligible for inclusion in the study.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00682760
Start Date
October 1 2005
End Date
August 1 2006
Last Update
May 22 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sang Yeul Lee
Seoul, South Korea, 120-752