Riluzole for the treatment of spasticity in the traumatic chronic spinal cord injury condition:Adaptive, Multicenter, placebo-controlled, randomised, double blind trial in a Rare Disorder

Centre Hospitalier Regional De Marseille0 个研究点目标入组 90 人2024年6月12日

适应症spasticity Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: spasticity
发起方: Centre Hospitalier Regional De Marseille
入组人数: 90
状态: 进行中（未招募）
最后更新: 去年

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2024年6月12日

结束日期

待定

最后更新

去年

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Centre Hospitalier Regional De Marseille

入排标准

入选标准

•Chronic traumatic SCI defined as: a. At least a 12\-month history of i. C4\-T12 traumatic SCI ii. Complete and incomplete ( AIS A,B,C,D) iii. With Spasticity (5\>MAS\>1 on at least adductor muscles and/or triceps surae muscles and NRS \= 4\), itten informed consent provided by subject, Male or Female, Aged 18 to 65 years at the time of screening, Judged by site investigator to be able to comply with evaluations at baseline and throughout the study, Last injection of BTX\-A in striated muscle more than 3 months ago and patients must have returned to their level of spasticity before BTX\-A injection, Last intrathecal (IT) injection of baclofen or per os administration of any myorelaxant should be more than 14 days ago (Step 1\), The dose of myorelaxant or Baclofen should be stable for \= 30 days prior to screening and kept at stable daily dose until the end of the protocol (Step 2\)., Stable on all other chronic medications for \= 30 days prior to screening, including analgesics, Stable on rehabilitation (methods and frequency) for \= 15 days prior to screening

排除标准

•Spinal cord injury of less than 12 months,, Neutropenia, liver enzymes (ALT/SGPT or AST/SGOT) 2 times the upper limit of normal (ULN) at screening visit, baseline elevations of several liver function tests (especially elevated bilirubin)., AIDS or AIDS\-related complex,, The systolic blood pressure measurement is \> 190 or \< 85 mm Hg and/or the diastolic blood pressure measurement is \> 105 or \< 50 mm Hg at screening., The ECG is abnormal at screening and judged to be clinically significant by the site investigator. Particular attention will be given to any sign suggesting conduction disorders., Treatment with any investigational drugs or device within 60 days of screening, Any myorelaxant medication including IT baclofen, taken by the subject in the last 14 days prior to screening (step 1\), Not stable under IT baclofen or per os myorelaxant medication for at least 30 days prior screening (step 2\), Not stable on all other chronic medications for \= 30 days prior to screening, including analgesics, injection of BTX\-A in striated muscle less than 3 months ago, Subject is currently using, and will continue to use for the next 14 days any of the following medications which are classified as Inhibitors of CYP 1A2 (e.g. diclofenac, diazepam, nicergoline, clomipramine, imipramine, fluvoxamine, phenacetin, theophylline, amitriptyline and quinolones) or Inducers of CYP 1A2 (e.g. rifampicin and omeprazole), Associated Brain lesion that might be the cause of spasticity,, Ongoing pregnancy and women with childbearing potential not using any form of efficacious contraception during study and 3 months after the end of study., Ongoing lactation and during 3 months after the end of study., known hypersensitivity to Riluzole, MAS\=1 or \=5on at least adductor muscles and/or triceps surae muscles or NRS \< 4, Presence of urinary infection, fever, pressure ulcer or other spasticity\-aggravating factors., Presence of other significant neurological or mental disorder or other illness, which would preclude accurate evaluation,, Recent history (less than 1 year) of chemical substance dependency or significant psychosocial disturbance,, Insufficient fluency in local language to complete neuropsychological, global and spasticity assessments, Active liver disease or clinical jaundice, Active malignancy