jRCT2031230711进行中（未招募）不适用
An open-label, uncontrolled, single-arm study of NT 201 in patients with Blepharospasm
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 80age old under（—）
- 性别
- All
入选标准
- •Subjects must meet all of the following inclusion criteria.
- •(1) Written Informed consent obtained from subject before participating
- •(2) Age >= 18 years and =< 80 years at the time of informed consent
- •(3) A clinical diagnosis of blepharospasm
- •(4) Jankovic Rating Scale (JRS) severity score >= 2 at the screening visit
- •(5) Only for pretreated patients:
- •At least 10 weeks must have passed between the last injection with botulinum toxin for blepharospasm and the screening visit
- •(6) Only for pretreated patients:
- •Patients presenting with symptoms of blepharospasm and need for injection of botulinum toxin.
排除标准
- •Subjects shall be excluded from this study if any of the following exclusion criteria.
- •(1) Psychotropic drugs induced blepharospasm
- •(2) The main symptom is apraxia of the eyelid opening
- •(3) Only for pretreated patients: No therapeutic response was observed with botulinum treatment for blepharospasm
- •(4) Treatment with botulism toxins for any injection other than blepharospasm (hemifacial spasm, cervical dystonia, cosmetics, etc.) within 16 weeks prior to the screening visit
- •(5) History of surgery for the treatment of dystonia including blepharospasm and myotomy surgery in the affected muscles
- •(6) Patients who have initiated, discontinued, or changed pharmaceuticals for the treatment of dystonia including blepharospasm within 12 weeks prior to screening visit
- •(7) Use any other investigational drugs/medical devices/products within 12 weeks prior to screening visit
- •(8) Patients who are planning to receive the prohibited concomitant medications from screening visit until the final visit
- •(9) Patients who are planning to start, discontinue or change the restricted concomitant medications by the end of the primary outcome measure from screening visit
- •(10) Myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease
- •(11) Infection in the area of the planned injection points or concerns about worsening systemic infection due to the local injection into the affected muscles
- •(12) Hypersensitivity to human serum albumin, sucrose, or Botulinum toxin A
- •(13) Pregnant women, patients who may be pregnant, patients who wish to become pregnant during the study period, or nursing mothers
- •(14) Women of childbearing potential who are unwilling or unable to use highly effective contraception from the date of informed consent until 16 weeks after the last injection of NT
- •[e.g., intrauterine device (IUD), intrauterine contraceptive system (IUS), oral contraceptives (low-dose pills), contraceptive surgery, or double barrier methods (e.g. condoms with spermicide, or condoms and pessaries) ]
- •(15) Severe or uncontrolled systemic diseases (e.g., cardiac, renal, pulmonary, hepatic, or gastrointestinal), malignant tumors, or known HIV infection in medical history
- •(16) Known or history of alcoholism or substance abuse
- •(17) Other than the above, patients judged by the investigator to be unsuitable for this study
结局指标
主要结局
-
Change from baseline in JRS severity score at 6 weeks after the first injection
次要结局
- JRS
- Blepharospasm Disability Index
- Patient Evaluation of Global Response
研究者
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