Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury: a Proof-of-concept Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- 6 min walking test (efficacy)
研究概览
简要总结
Randomized placebo-controlled safety and feasibility study with crossover design (3 arms). Placebo or Rimonabant 2.5mg or Rimonabant 5mg will be administered for 5 days. Exploratory efficacy will be tested using six-min walking test.
详细描述
Randomized placebo-controlled safety and feasibility study with crossover design (3 arms). Placebo or Rimonabant 2.5mg or Rimonabant 5mg will be administered for 5 days. Exploratory efficacy will be tested using six-min walking test.
Main goal is to test safety 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
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Traumatic spinal cord injury
- •Incomplete lesion (AIS D)
- •Neurological level between C4 and L1
- •Chronic stage (>1 year since injury)
- •Preserved walking ability for at least 5 m (aid allowed)
- •Psychiatric assessment to exclude individuals with high suicide risk
- •Capability to provide informed consent
- •For fertile women, possibility to use anti conceptive methods
排除标准
- •Non traumatic spinal cord injury
- •AIS A, B, C 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 kidney or liver dysfunction
- •Severe depression
- •Fatigue treatment in the last 6 months
- •Impossibility to reach the Hospital
- •Impossibility to provide informed consent
研究组 & 干预措施
Placebo
Two pills of placebo will be administered for 5 consecutive days, once per day.
干预措施: Rimonabant (Drug)
Rimonabant 2.5 mg
One pill of placebo and one pill of Rimonabant 2.5mg will be administered for 5 consecutive days, once per day.
干预措施: Rimonabant (Drug)
Rimonabant 5 mg
Two pills of Rimonabant 2.5mg will be administered for 5 consecutive days, once per day.
干预措施: Rimonabant (Drug)
结局指标
主要结局
6 min walking test (efficacy)
时间窗: 5 days
6 min walking test (meters and number of stops are reported)
ECG (safety)
时间窗: 8 days
Number of participants with clinically significant abnormal ECG readings
Modified Ashworth Scale (safety)
时间窗: 15 days
Range 0-4 (higher values more severe)
Adverse events (safety)
时间窗: 150 days
number of AE
Biochemical and urine analysis (safety)
时间窗: 8 days
Number of participants with clinically significant abnormal laboratory tests results
Beck Depression Inventory (BDI) (safety)
时间窗: 15 days
Range 0-63 (higher values more severe)
Hospital Anxiety and Depression Scale (HAD) (safety)
时间窗: 15 days
Range 0-21(higher values more severe)
Penn Scale (safety)
时间窗: 15 days
Range 0-4 (higher values more severe)
次要结局
- Patient global impression of changes (PGIC) (efficacy)(5 and 15 days)
- European Quality of Life -5 Dimensions (EQ-5D) (efficacy)(8 days)
- Pain numeric rating scale(8 days)
- 6 min walking test (efficacy)(15 days)
- WISCI II (efficacy)(5 and 15 days)
- Motor Score (efficacy)(8 days)
- Fatigue Severity Scale (FSS) (Efficacy)(5 and 15 days)
- Health state visual analogically scale(8 days)
- 10 m test (efficacy)(5 days and 15 days)
- Borg Scale (efficacy)(5 days and 15 days)
研究者
Antonio Oliviero
Principal Investigator
Hospital Nacional de Parapléjicos de Toledo