EUCTR2007-000697-23-DE进行中（未招募）不适用
Prospective, single-arm, single-center, open-label trial to investigate the tolerability of NT 201 and quality of life of patients in the treatment of blepharospasm with shortened injection intervals
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 58
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Willingness of the patient to participate as documented by signed informed consent
- •- Male or female pretreated outpatient between 18 and 80 years of age (inclusively)
- •- A clinical diagnosis of bilateral BEB characterized by spontaneous, spasmodic, intermittent or persistent involuntary contractions of the orbicular oculi muscles
- •- Medical need for treatment with shortened injection intervals (< 12 weeks) confirmed by patient and investigator
- •- Botulinum toxin Type A treatment effect after last injection before study entry according to patient’s self-assessment
- •- Blepharospasm Disability Index (BSDI) before injection =1,6
- •- Source documentation of the last three consecutive injection sessions with Botulinum toxin Type A
- •- On a stable dose of other medications (if any) used for focal dystonia treatment (e.g. anticholinergics and benzodiazepines) for at least 3 months prior to visit V1 and expected throughout the study
- •- Negative pregnancy test at trial entry for female of childbearing potential (premenopausal female or postmenopausal female with less than 12 months after last menses)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Atypical variant of blepharospasm caused by inhibition of levator palpebrae muscle (apraxia of the eyelid)(apraxia of the eyelid)
- •- Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome), as well as amyotrophic lateral sclerosis or any other significant neuromuscular disease which might interfere with the trial
- •- The previous three injections with Botulinum toxin Type A with more than 50 Units [U] per eye per injection session
- •- Treatment with Botulinum toxins for any indication other than BEB within 4 months prior to baseline and during the trial
- •- Frontalis suspension surgery in medical history
- •- Known hypersensitivity to human serum albumin, sucrose or Botulinum toxin Type A
- •- Known current alcoholism or other drug abuse / dependence
- •- Ongoing severe or uncontrolled systemic disease (e.g., cardiac, renal, pulmonary, hepatic, or gastrointestinal)
- •- Uncured malignant tumor or known HIV infection
- •- Present or pre-existing blood coagulation disorders including therapeutic or prophylactic anticoagulation (e.g. heparin, phenprocoumon)
- •- Infections in the area of the planned injection points or systemic infections presenting a hazard for local injections
- •- Treatment with non-authorized medications (see section Prior and Concomitant Therapy)
- •- Planned elective surgery under general anesthesia during the trial
- •- Nursing woman or woman of childbearing potential not using highly effective methods of birth control, defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as hormonal contraception or intrauterine contraceptive device or combination of two barrier methods (e.g. condom or diaphragm plus spermicidal cream)
- •- Current participation or participation within the past 90 days in another clinical trial
- •- Previous participation in this clinical study
- •- Employees or direct relatives of an employee of the CRO, the Study Center or Merz Pharmaceuticals
研究者
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