NCT03641950已完成4 期
Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Botulax® in Patients With Essential Blepharospasm
Hugel1 个研究点 分布在 1 个国家目标入组 249 人开始时间: 2015年4月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- Total score change from baseline at 4 weeks post-injection of Jankovic Rating scale
研究概览
简要总结
The purpose of this study is evaluate the efficacy and safety of Botulax® in the treatment of Essential blepharospasm.
详细描述
Multi-center, single arm, open-label, Phase IV clinical trial to evaluate the efficacy and safety of Botulax® in Subjects with essential blepharospasm
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Men and women at the age of 18 or older
- •Subjects diagnosed with essential blepharospasm with Jankovic Rating Scale (JRS) frequency and severity sum score ≥2 at screening
- •Individuals who agree to participate in the clinical study and voluntarily sign the written informed consent form
- •Subjects who are cooperative, have a good understanding of the clinical study, and can comply with study procedures until the end of the study
排除标准
- •Subjects who had received surgery such as orbicularis oculi resection or facial nerve block for the treatment of the study indication
- •Subjects with a history of hypersensitivity reactions to any of the components of the investigational product (botulinum toxins, serum albumin, etc.)
- •Subjects with secondary blepharospasm
- •Subjects with the hemifacial spasm
- •Subjects on treatment with muscle relaxants, benzodiazepines, anticholinergics, or benzamides who had changes in medication within 4 weeks prior to screening or have been on stable medication but are expected to have changes in medication while participating in the study
- •Subjects who administered any of the following drugs within 7 days prior to screening: drugs with muscle relaxation activity such as aminoglycoside antibiotics or other antibiotics (spectinomycin HCl, polypeptide antibiotics, tetracycline antibiotics, lincomycin antibiotics)
- •Subjects who administered medications similar to the investigational product (botulinum toxin type A) within 12 weeks
- •Subjects with systemic neuromuscular junction disorders: myasthenia gravis, Lambert-Eaton syndrome, or amyotrophic lateral sclerosis
- •Pregnant and lactating women
- •Women of childbearing potential who are planning to become pregnant within the next 3 months or are not using an appropriate method of contraception (contraceptive methods with an annual failure rate of less than 1% if used properly and continuously, including implant, injection, oral contraceptive, at least one barrier method such as intrauterine device [IUD], hormone IUD, abstinence, or vasectomized partner)
研究组 & 干预措施
Botulinum Toxin Type A (Botulax)
Experimental
Botulinum Toxin Type A (Botulax)
干预措施: Botulinum toxin type A (Drug)
结局指标
主要结局
Total score change from baseline at 4 weeks post-injection of Jankovic Rating scale
时间窗: At 4 weeks post-injection
To evaluate the change of JRS (Jankovic Rating scale) score at 4 weeks post treatment based on baseline(0 week). JRS total score will be calculated as the sum (0\~8) of two sub-scores of severity and frequency (0\~4 each for severity and frequency) of blepharospasm.
次要结局
- Total score change from baseline at 16 weeks post-injection of Jankovic Rating scale(At 0 weeks and 16 weeks post-injection)
- Change from baseline at 4 weeks and 16 weeks of Disability Index(At 4 weeks and 16 weeks post-injection)
- Global Response evaluated by investigator at 4 weeks and 16 weeks after post-injection(At 4 weeks and 16 weeks post-injection)
- Change from baseline at 4 weeks and 16 weeks of WHO-Quality of Life(QOL)(At 4 weeks and 16 weeks post-injection)
研究者
研究点 (1)
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