NCT01791881已完成3 期
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
Hugel9 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 9
- 主要终点
- Rate of patients with an improvement more than one Grade of Severity of Spasm (by Scott's Method)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Botulinum toxin type A(Botox®)
Active Comparator
Botulinum toxin type A(Botox®)
干预措施: Hugeltox (Drug)
Botulinum toxin type A(Botox®)
Active Comparator
Botulinum toxin type A(Botox®)
干预措施: Botulinum Toxin Type A(Botox®) (Drug)
Botulinum toxin type A(Hugeltox)
Experimental
Botulinum toxin type A(Hugeltox)
干预措施: Hugeltox (Drug)
Botulinum toxin type A(Hugeltox)
Experimental
Botulinum toxin type A(Hugeltox)
干预措施: Botulinum Toxin Type A(Botox®) (Drug)
结局指标
主要结局
Rate of patients with an improvement more than one Grade of Severity of Spasm (by Scott's Method)
时间窗: at 4 weeks post-injection
次要结局
- (1) Duration of action days(6 months)
- (2) Grades of Severity of Spasm (by Scott's Method), Functional Visual Status(at four weeks post-injection)
- (3) Rate of patients with a Grade-0 or Grade-1 of Severity Spasm (by Scott's Method)(at four weeks post-injection)
- (4) Rate of patients with an improvement more than two Grade of Severity of Spasm (by Scott's Method)(at four weeks post-injection)
研究者
研究点 (9)
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