NCT02096913已完成1 期
The Rho-Inhibitor Ibuprofen for the Treatment of Acute Spinal Cord Injury: Investigation of Safety, Feasibility and Pharmacokinetics
Jan M. Schwab, MD, PhD1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of patients with severe gastroduodenal bleedings as a measure of safety
研究概览
简要总结
The Ibuprofen - Spinal Cord Injury (SCI) - Safety trial investigates tolerability and feasibility of "small molecule" (Ibuprofen) mediated Rho-inhibition as putative neuroprotective, plasticity-enhancing and neurorestaurative intervention. The primary safety analysis is based on the incidence of severe gastrointestinal bleedings. In addition, the feasibility of recruitment procedure, and oral administration of the compound within the multidisciplinary setting of acute intensive medical care will be explored. Furthermore, the pharmacokinetics of Ibuprofen under the condition of acute motor complete SCI will be investigated. Secondary endpoints will permit preliminary statements about effects on neuropathic pain, spasticity, and neurological function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute SCI of the cervical spine due to trauma
- •Time frame of 4-21 days post-trauma
- •Motor complete injury AIS A and B
- •Neurological level of the lesion C4-T4
- •No participation in a different clinical trial according to German Pharmaceuticals Act (AMG) 1 month before and during participation in the current trial
- •The patient has been informed and his/her written consent has been obtained
- •Age: 18 to 65 years
- •For women of reproductive age: Negative pregnancy test and highly effective contraception (defined as Pearl Index < 1) or sexual abstinence during participation in the trial
排除标准
- •Multifocal lesions of the spinal cord
- •Penetrating spinal cord injury
- •Accompanying traumatic brain injury (TBI) with visible structural lesions including intracranial hemorrhage on diagnostic imagesSigni
- •Significant accompanying injury to the peripheral nervous system, particularly plexus lesions
- •Acute or chronic systemic diseases accompanied by neurological deficits or that have caused permanent neurological deficits which may overlay or hinder the registration of sensomotor functions (e.g. multiple sclerosis, Guillain-Barré syndrome, HIV infection, Lues etc.)
- •Malignant neoplasms, except if these are in complete remission.
- •Mental diseases or dementia which, in the investigator's opinion, limit the patient's cooperation in respect of the intake of the study medication and/or significantly hinder the registration of follow-up parameters
- •Hemophilia
- •History of myocardial infarction or stroke
- •Current and persistent misuse of illegal drugs or alcohol
- •Hypothermia below 35 C°
- •Pregnancy and lactation
- •All further contraindications to the study medication, including other ingredients of the pharmaceutical form according to the Summary of Product Characteristics (SPC)
- •Known hypersensitivity to the active substance contained in the concomitant medication Pantoprazole or one of the components of the drug.
- •Intake of Ibuprofen or intake of other active substances from the group of Nonsteroidal Anti-inflammatory Drugs (NSAIDs; e.g., Diclofenac, Indometacin) or the intake of NSAIDs in maximum recommended daily doses during one week prior to enrolment in the trial
- •Simultaneous intake of salicylates, particularly acetylsalicylic acid
- •Simultaneous intake of oral anticoagulants
- •Simultaneous intake of systemic glucocorticoids
- •Unwilling to consent to storage and transfer of pseudonymized medical data for the purpose of the clinical trial
- •Admitted to an institution by a court or official order (pursuant to AMG §40 (1) 4)
研究组 & 干预措施
Dolormin® extra (Ibuprofen) 4 weeks
Active Comparator
干预措施: Dolormin® extra (Ibuprofen) (Drug)
Dolormin® extra (Ibuprofen) 12 weeks
Active Comparator
干预措施: Dolormin® extra (Ibuprofen) (Drug)
结局指标
主要结局
Number of patients with severe gastroduodenal bleedings as a measure of safety
时间窗: up to 4 months
Safety of lbuprofen as measured by the occurence of severe gastroduodenal bleedings documented as serious adverse events (SAE)
次要结局
- Neurological sensory function on the ISNCSCI/ASIA sensory score change from baseline(baseline, 4 weeks and 6 months)
- Spasticity on the Modified Ashworth Scale (MAS)(4 weeks and 6 months)
- Pain on the Neuropathic Pain Scale (NPS)(baseline, 4 weeks and 6 months)
- International standards for neurological classification of spinal cord injury (ISNCSCI) - ASIA impairment scale (AIS) change from baseline(baseline, 4 weeks and 6 months)
- Neurological motor function on the ISNCSCI/ASIA motor scores change from baseline(baseline, 4 weeks and 6 months)
- Number of participants with adverse events as a measure of safety and tolerability(up to 6 months)
- Ibuprofen levels in plasma(Arm I (day 1 and week 4), Arm II (day 1, week 4 and 12) 1.5 and 3 hours post-dose)
- Ibuprofen levels in cerebrospinal fluid (CSF)(Arm I (day 1 and week 4), Arm II (day 1, week 4 and 12) 3 hours post-dose)
研究者
Jan M. Schwab, MD, PhD
Prof. Dr. Dr.
Charite University, Berlin, Germany
研究点 (1)
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