2024-514882-20-00尚未招募1/2 期
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
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- the improvement of Modified Ashworth Score better than 1 point, or 11 points Numerical Rating Scale (0-10 NRS) spasticity score better than 20% between Week 0 and Week 2.
研究概览
简要总结
The study will be conducted in two steps:
- Determination of the Minimal Effective Dose (MED) among the four doses of the panel 2)Estimation of the probability of response associated to the MED. Each step has a main objective: Step 1 Objective: To determine a daily dose of Riluzole that improves spasticity in patients with chronic SCI Step 2 Objective: To demonstrate, in a phase 2b trial, the efficacy of Riluzole to improve spasticity versus placebo, in patients with chronic SCI
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
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
结局指标
主要结局
the improvement of Modified Ashworth Score better than 1 point, or 11 points Numerical Rating Scale (0-10 NRS) spasticity score better than 20% between Week 0 and Week 2.
the improvement of Modified Ashworth Score better than 1 point, or 11 points Numerical Rating Scale (0-10 NRS) spasticity score better than 20% between Week 0 and Week 2.
次要结局
- Safety : side effects
- Pharmacokinetics (PK): Blood sampling time points will be estimated using Limited Sampling Strategy (according to the selected galenic form and sex). Individual PK parameters will be calculated using standard compartimental approaches. In particular, exposure parameters (i.e., Cmax, Ctrough, AUC) will be evaluated.
- Electrophysiology: H reflex, mean F wave amplitude, surface EMG at T0 (before drug intake) at T2h (2h after drug intake) (only in Step 2)
- Efficacy : 0-10 NRS score, Modified Ashworth score (MAS) on at least adductor muscles and/or triceps surae, Patient Global Impression of Change, Penn Spasm frequency scale
- Pain : Visual Analog Scales, Neuropathic Pain Symptom Inventory, International Spinal Cord Injury Basic Data Set (ISCIPDS)
- Activities and Participation: Spinal Cord Injury Independence Measure (SCIM scale) (only in Step 2); Personal therapeutic objectives determined at baseline, Goal Attainment Scale (GAS) (Adductor muscle spasticity...)
- Bladder dysfunction: Bladder diary (items on urinary frequency, daytime incontinence...) (Only in Step 2)
研究者
PROJET MANAGER
Scientific
Centre Hospitalier Regional De Marseille
研究点 (3)
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