EUCTR2006-000073-29-DE进行中（未招募）不适用
Prospective, randomised, double-blind, placebo-controlled multicentre pilot trial to investigate the impact of an early use of NT 201 in patients with an acute cerebrovascular event on the development of upper limb spasticity - NT Early
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
- 11
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
- •- Female or male patients aged =18 years
- •- Acute cerebrovascular event (e.g. any kind of stroke or cerebral haemorrhage)
- •- Necessity for rehabilitation measure
- •- Newly developed focal spasticity in upper limb
- •- Spasticity with = 1 point on the MAS in the wrist flexors or spasticity with
- •=1 point on the MAS in the wrist flexors and elbow flexors
- •- Start of injection of trial medication within 3 to 30 days after the event
- •- Written informed consent obtained by patient or a witness in case the patient
- •is unable to write
- •- Negative urine pregnancy test at trial entry for women of childbearing potential
- •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
- •- Current or previous treatment with botulinum toxin of any serotype and for any body region
- •- Severe aphasia resulting in inability of the patient to follow the consent procedure
- •- Severe atrophy of the target limb muscles
- •- Any rheumatic or orthopaedic disease of the affected limb
- •- Planned surgery of the target limb
- •- Surgical treatment in the target limb for any indication within 8 weeks prior to screening
- •- Hypersensitivity to human serum albumin, sucrose or botulinum neurotoxin type A
- •- Anticoagulation therapy which requires an INR >2.5
- •- Treatment with intravenously administered heparin within 24 hours prior to first injection of trial medication
- •- Infection in the area of the planned injection points or systemic infections presenting a hazard for local injections
- •- Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis or any other significant neuromuscular disease which might interfere with the study
- •- Use of non-authorised concomitant medication
- •- Severe and/or unstable hypertension
- •- Severe or uncontrolled systemic disease (e.g. cardiac, renal, pulmonary, hepatic or gastrointestinal), current malignancy or anamnestic HIV infection
- •- Clinically relevant pathological findings in laboratory parameters, indicating active disease of vital organs
- •- Nursing mothers and women of childbearing potential without reliable means of contraception (hormonal contraception or barrier contraception combined with intrauterine contraception device) and women planning pregnancy during the course of the trial
- •- Participation in a clinical study within the last 1 month prior to screening
- •- Previous randomisation in this clinical study
- •- In the opinion of the investigator the patient is unlikely to complete all visits
- •- Other contraindications which in the investigator’s opinion preclude participation in the study
研究者
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