Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 65
- 试验地点
- 3
- 主要终点
- Change From Baseline to Week 4 in Blepharospasm Disability Index
研究概览
简要总结
This pilot study estimates the treatment effects of two different types of botulinum toxin type A in the treatment of Blepharospasm. Blepharospasm is characterised by excessive contraction of the muscles around the eye and can lead to repetitive blinking or sustained closure of the eyelids.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with benign essential blepharospasm
- •Received ≥20U/eye of BOTOX® for at least one visit prior to study entry and required, in the investigators opinion, the same dose at the study injection visit.
- •Combined Jankovic Rating Score of >2
排除标准
- •Female subjects who were pregnant, breastfeeding, or who were of childbirth potential and not practicing birth control.
- •Profound atrophy of the muscles in the target area(s) of injection.
- •Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function.
- •Known significantly impaired renal and/or hepatic function
研究组 & 干预措施
1
干预措施: Botulinum Toxin Type A 900kDa (Biological)
2
干预措施: Botulinum Toxin Type A 150kDa (Biological)
结局指标
主要结局
Change From Baseline to Week 4 in Blepharospasm Disability Index
时间窗: Baseline to Week 4
Blepharospasm Disability Index is a validated 5-point scale (0-4) with six items (e.g., reading, driving a vehicle). 0 - no impairment, 1 - mild impairment, 2 - moderate impairment, 3 - severe impairment, 4 - not possible due to disease, N/A - Not applicable. The total score ranged from 0 (no impairment) to 24 (not possible due to disease). A negative change from baseline indicated improvement.
次要结局
- Change From Baseline to Week 4 and Week 8 in Total Jankovic Rating Scale (JRS) (Severity and Frequency Measured on a Scale of 0-4)(Baseline to Week 4 and Week 8)
- Change From Baseline to Week 8 in Blepharospasm Disability Index(Baseline to Week 8)
- Duration of Action(Interval between initial injection (Week 0) and final visit (Week 11 through Week 14))
- Changes From Baseline to Week 4 and Week 8 in Patient Global Assessment (PGA) Score(Baseline to Week 4 and 8)