NCT00234507已完成2 期
Phase II, Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Study to Assess the Efficacy and Safety of a Single Administration, by Subcutaneous Injection, of Three Doses of Dysport (40 Units/Eye, 80 Units/Eye, and 120 Units/Eye) for the Treatment of Benign Essential Blepharospasm
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 120
- 试验地点
- 27
- 主要终点
- The functional disability as measured by the percentage of normal activity (PNA) derived from the Blepharospasm Disability Scale (BDS) at 4 weeks post-treatment.
研究概览
简要总结
The purpose of this study is to compare the effectiveness of 3 doses of Dysport® with placebo by assessing functional disability in blepharospasm.
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
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
- •patients with a confirmed diagnosis of bilateral benign essential blepharospasm, and having symptoms of such for at least 6 months prior to the baseline visit
- •naïve patients to botulinum toxin type A treatment, or patients who had received a single treatment of botulinum toxin type A, or those who had demonstrated a satisfactory response, in the investigator's opinion, to the last 2 injections of botulinum toxin type A with a minimum of 12 weeks since the last injection and where a further injection at full dosage was now indicated
- •patients with a minimum score of 8 on the BDS
排除标准
- •patients with either neuroleptic-induced blepharospasm, isolated levator dysfunction or apraxia
- •previous surgical, chemical and thermal myectomy or neurectomy
- •any condition where intramuscular injection is contraindicated
- •ophthalmolgical infection
- •myasthenia gravis or other disorders of the neuromuscular junction
- •prescription of antispastic, muscle relaxants or medications affecting neuromuscular junction transmission, or medication where the dose or choice of medication has not been constant for the last 30 days
结局指标
主要结局
The functional disability as measured by the percentage of normal activity (PNA) derived from the Blepharospasm Disability Scale (BDS) at 4 weeks post-treatment.
次要结局
- Change from baseline in BDS, FIM, severity of oculo-facial spasm and in severity of global impairment due to blepharospasm (measured by VAS) at 4, 8, 12 and 16 weeks post treatment.
- To compare the safety of each of the 3 doses of Dysport with placebo in terms of adverse event incidence, vital signs and physical examinations.
- Frequency of involuntary movements (FIM) and severity of oculo-facial spasm (measured by the Severity Rating Scale [SRS]) at 4 weeks post-treatment.
- Patient assessment of benefit and need for re-treatment, evaluated at the end of the study.
- Investigator assessment of benefit and need for re-treatment, evaluated at the end of the study.
- Severity of global impairment due to blepharospasm as measured by the Visual Analogue Scale (VAS) at 4, 8, 12 and 16 weeks post-treatment.
- Percentage of patients withdrawn from the study due to lack of efficacy at each assessment point.
- PNA, FIM and SRS at 8, 12 and 16 weeks post-treatment.
研究者
研究点 (27)
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