EUCTR2016-001227-31-DE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 Zurich, University Hospital Balgrist, Spinal Cord Injury Center0 个研究点目标入组 132 人开始时间: 2018年6月6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
- 132
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
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 132
- •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.
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