Efectos de un Antagonista/Agonista Inverso Del Receptor CB1 (Rimonabant) Sobre la Capacidad Para la deambulación en Lesionados Medulares Incompletos
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Biochemical and urine analysis (safety)
研究概览
简要总结
This is a placebo controlled study comparing Rimonabant 5 mg per day for 90 days with placebo for the same period. Objective is to improve walking abilities of spinal cord injury individuals (incomplete lesions) and demonstrate that it is a safe treatment in spinal cord injury population.
详细描述
This is a placebo controlled study comparing Rimonabant 5 mg per day for 90 days with placebo for the same period.
Main goal are to test safety and efficacy (impairment of walking abilities teste with the 6 min walking test) of Rimonabant in a specific population (incomplete spinal cord injury).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Placebo controlled
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 yo and <75yo
- •Non progressive spinal cord injury
- •Incomplete lesion (AIS C or D)
- •Neurological level between C4 and L1
- •Chronic stage (>1 year since injury)
- •Preserved walking ability for at least 5 m (aid allowed)
- •Capability to provide informed consent
- •For fertile women, possibility to use anti conceptive methods
排除标准
- •Age <18 yo or >75
- •AIS A, B or E
- •Neurological level above C4 or below L1
- •Subacute stage (<1 year since injury)
- •Preserved walking ability for less than 5 m (aid allowed)
- •Pregnancy or breast feeding
- •For fertile women, impossibility to use anti conceptive methods
- •anticoagulant treatment
- •Hypothyroidism
- •Severe bone, kidney or liver disfunction
- •Impossibility to reach the hospital
- •Impossibility to rovide informed consent
研究组 & 干预措施
Rimonabant
Rimonabant 5mg
干预措施: Rimonabant (Drug)
Placebo
Placebo
干预措施: Rimonabant (Drug)
结局指标
主要结局
Biochemical and urine analysis (safety)
时间窗: 120 days
Number of participants with clinically significant abnormal laboratory tests results
ECG (safety)
时间窗: 120 days
Number of participants with clinically significant abnormal ECG readings
Modified Ashworth Scale (safety)
时间窗: 90 days
Range 0-4 (higher values more severe)
Penn Scale (safety)
时间窗: 90 days
Range 0-4 (higher values more severe)
Adverse Events (Safety)
时间窗: 120 days
Number of AE
Hospital Anxiety and Depression Scale (HAD) (safety
时间窗: 120 days
Range 0-21(higher values more severe)
6 min walking test (efficacy)
时间窗: 90 days
6 min walking test (meters and number of stops are reported)
Pain numeric rating scale (safety)
时间窗: 90 days
Range 0-10 (higher values more severe)
Questionnaire of falls (safety)
时间窗: 120 days
Number of falls
次要结局
- 10 m test (efficacy)(90 days)
- Patient global impression of changes (PGIC) (efficacy)(90 days)
- Health state visual analogically scale (efficacy)(90 days)
- Fatigue Severity Scale (FSS) (Efficacy)(90 days)
- Borg Scale (efficacy)(90 days)
- Motor Score (efficacy)(90 days)
- European Quality of Life -5 Dimensions (EQ-5D) (efficacy)(90 days)
- Spinal Cord Independence Measures, SCIM (efficacy)(90 days)
研究者
Antonio Oliviero
Antonio Oliviero
Hospital Nacional de Parapléjicos de Toledo