EUCTR2012-004373-80-ES进行中（未招募）不适用
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects with Acute Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 164
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. Acute traumatic injury to the cervical neurological spinal cord as follows:
- •a. AIS grade A with a level of injury at either C4, C5, C6, or C7 (for C4, the subject must have at least 1 point of motor activity within the ZPP inclusive of C5 to T1). In addition, the AIS A subject may be included if ALL of the following are present 1) the most caudal intact sensory segment (both pinprick and light touch) is C3, 2) at least one side (right or left) has both intact pinprick and light touch sensation in the C4 dermatome, AND 3) at least 1 point of motor activity within the zone of partial preservation (ZPP) inclusive of C5 to T1
- •b. AIS grade B or C with a neurological level of injury at either C3, C4, C5, C6, C7, or C8 AND a total Lowere Extremity Mote Score of 5 or fewer motor points
- •2. Closed single traumatic spinal cord injury occurring within 12 hours of first dosing
- •3. Male or female cervical AIS A subjects ?16 to ?80 years and male or female cervical AIS B or C subjects ?16 to ?70 years
- •4. Females of childbearing potential and males must agree to maintain adequate contraception (eg, condoms, intrauterine devices, diaphragm, spermicide, contraceptive patch, oral contraceptive pills, progestin injections, under-skin contraceptive implants, vaginal ring) for the first 35 days of the study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 3
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 151
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Unable to obtain informed consent (either from the subject or from the subject?s Legally Authorised Representative)
- •2. Women who are breastfeeding (if unwilling to stop for the first 35 days of the study) or are pregnant
- •3. Coma or significant impairment in the level of consciousness that interferes with the performance or interpretation of protocol specified assessments
- •4. Any disease, concomitant injury, or condition that interferes with the performance or interpretation of the protocol specified assessments
- •5. Unable, as determined by the investigator, or unwilling to discontinue use of potent P-glycoprotein (P-gp) inhibitors (cyclosporine A, erythromycin, itraconazole, ketoconazole, nelfinavir, quinidine, reserpine, ritonavir, saquinavir, tacrolimus, and verapamil) for the first 35 days of the study
- •6. Unable, as determined by the investigator, or unwilling to discontinue use of potent cytochrome P450 (CYP) 3A4/5 inducers (eg, phenytoin, carbamazepine, oxcarbazepine, phenobarbital, efavirenz, nevirapine, etravirine, rifampicin, modafinil, hyperforin [constituent of St Johns Wort], and cyproterone) for the first 35 days of the study
- •7. Renal compromise (serum creatinine greater than 1.5 times the age- and sex-appropriate Upper Limit of Normal (ULN) for the local laboratory) at screening before the first dose of study drug
- •8. Severe hepatic dysfunction (serum ALT, AST, and GGT ALL greater than 2.5 times the age- and sex-appropriate ULN) OR hepatic impairment (detectable ascites, serum bilirubin greater than 2 mg/dL, serum albumin less than 3.5 g/dL, and prothrombin time prolonged by more than 6 seconds above the ULN for the local laboratory in the absence of anticoagulant therapy) at screening before the first dose of study drug
- •9. Concomitant spinal cord injury or abnormality as determined by routine imaging:
- •a. Conclusive radiological evidence of complete spinal cord transection
- •b. Multiple injuries to the neurological spinal cord at different levels
- •10. History of symptomatic cervical spinal stenosis with myelopathy as a factor confounding subject assessment
- •11. Unlikely to be available for follow-up as specified in the protocol
- •12. Participated in a previous clinical study and received an investigational product within 30 days of screening
- •13. Previous exposure to SUN13837
- •14. Allergy to SUN13837 or any of its excipients
- •15. Any other issue which, in the opinion of the investigator, will make the subject unsuitable for study participation
研究者
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