EUCTR2016-001227-31-CZ进行中（未招募）1 期
Antibodies against Nogo-A to enhance plasticity, regeneration and functional recovery after acute spinal cord injury
niversity of Zurich0 个研究点目标入组 114 人开始时间: 2019年11月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 114
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
- •1. Male or female, 18 through 70 years of age
- •2. Acute cervical spinal cord injury (SCI) (Neurological level of injury C1 = lesion = C8) with confirmed classification of ASIA impairment scale (AIS) A-D at screening and predicted upper extremities motor score (UEMS) recovery of less than 41/50 (according to the URP prediction model)
- •3. 4-28 days post-injury (i.e. initiation of bolus injection within 4-28 days post-injury)
- •4. Tetraplegic patients who are allowed to start treatment are those who either do not require mechanical ventilation or who do not completely depend on mechanical ventilation but show some degree of spontaneous ventilation. Only those modes of ventilation where the patient show active initiation of breathing are allowed (e.g. continuous positive airway pressure (CPAP))
- •5. Hemodynamically and clinically stable according to the acute SCI condition at baseline
- •6. For patients of childbearing potential, use of reliable means of contraception
- •7. Written informed consent by patient before any study assessment is performed. If the patient is only able to consent orally a witness signs and confirms the patient’s consent
- •8. Cooperation and willingness to complete all aspects of the study
- •9. Ability of subject to understand character and individual consequences of the study
- •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 114
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. Complete anatomical transection confirmed by magnetic resonance imaging (MRI).
- •2. Trauma caused by ballistic or other injury that directly penetrates the spinal cord including gunshot and knife wounds.
- •3. Multiple levels of clinically relevant spinal cord lesions.
- •4. Major brachial or lumbar plexus damage/trauma.
- •5. Significant head trauma (e.g. cortical damage/lesion), or other injury that was, in the opinion of the investigator, sufficient to interfere with the assessment of the spinal cord function or otherwise compromise the validity of the patient's data.
- •6. Other significant pre-existing or current severe systemic disease such as lung, liver (exception: history of uncomplicated Hepatitis A), gastrointestinal, cardiac, immunodeficiency (including anamnestic known HIV) or kidney disease; or active malignancy or any other condition as determined by history or laboratory investigation that could cause a neurological deficit including syphilis, myelopathy, clinically relevant polyneuropathy, etc.
- •7. History of or an acute episode of Guillain-Barre syndrome.
- •8. History of recent (6 months) meningitis or meningoencephalitis.
- •9. History of refractory epilepsy.
- •10. Patients with uncontrolled bleeding diathesis and/or who require uninterrupted concomitant therapeutic anticoagulation (e.g. phenoprocoumon (Marcumar®), heparin/heparinoids and new oral anticoagulants) at a higher dose than for the prophylaxis of venous thromboembolism
- •11. Presence of any unstable medical or psychiatric condition (defined by the Diagnostic and Statistical Manual of Mental Disorders, Edition 4 (DSM-IV)) that could reasonably have been expected tosubject the patient to unwarranted risk from participation in the study or result in a significant deterioration of the patient's clinical course.
- •12. Drug dependence (as defined by DSM-IV) any time during the 6 month’s preceding study entry.
- •13. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL).
- •14. History of a life-threatening allergic or immune mediated reaction.
- •15. Patients with the presence of infection around the location where the spinal needle insertions are planned for applying the intrathecal injections.
- •16. Inability to communicate effectively with the neurological examiner such that the validity of the patient's data could be compromised.
- •17. Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
- •18. Patients who are unconscious, including those patients who are unconscious due to medication causing marked sedation.
- •19. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure.
研究者
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