Efficacy and Safety of Growth Hormone (GH) Treatment in Spinal Cord Injury(SCI): A Triple-blinded, Randomised, Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Motor Score of the American Spinal Injury Association (ASIA) scale
研究概览
简要总结
Objectives: To evaluate the efficacy and safety of one year treatment based on daily doses of exogenous growth hormone (GH) in patients with traumatic spinal cord injury. The first six months the pharmacological treatment will be associated to rehabilitation treatment.
The main hypothesis is that GH can improve motor function of patients with traumatic spinal cord injury below the lesion level. The hypothesis is based on possible effects of GH at muscle and synaptic level. GH can also promote axonal growth and regeneration.
Design: Clinical trial placebo-controlled, double-blind intervention with blind evaluation by third parties and blinding in the analysis of data (triple-blind design).
Duration of intervention and monitoring: 364 days.
Primary outcome measures. Changes of the American Spinal Injury Association (ASIA) scale (motor score)
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)
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
- •Traumatic Spinal cord injury
- •Incomplete (ASIA scale B or C)
- •Level of injury: Between C4 and D12
- •More than 18 months from the SCI injury.
排除标准
- •Non traumatic Spinal cord injury
- •Complete SCI (ASIA A)
- •Incomplete (ASIA D or E)
- •Less than 18 months from the SCI
- •Intensive Care Unit (ICU) staying for a period of 2 months or more
- •More than 3 urological infections in the last year
- •Pneumonia in the 6 months prior to the study
- •Severe respiratory failure
- •History of head trauma
- •Severe psychiatric disorder
- •A history of heart disease, diabetes or hypertension
- •Concomitant Neurological Diseases
- •Regular use of substances of abuse
- •Patients with severe kidney and / or liver failure.
- •Patients who can not be included in an intensive rehabilitation program
- •Patients who are pregnant or breast-feeding
- •History of malignancy
- •Impossibility to obtain informed consent
研究组 & 干预措施
GH
Administration of a daily dose of GH (0.4mg)for 1 year
干预措施: GH (Drug)
Placebo
Administration of a daily dose of placebo for 1 year
干预措施: Placebo (Drug)
结局指标
主要结局
Motor Score of the American Spinal Injury Association (ASIA) scale
时间窗: 12 months
Motor score of the ASIA scale reports the strenght of 10 key muscles in each body side (5 key muscles in upper limb and 5 key muscles in lower limb). The strenght is rated between 0 and 5 (Medical Research Council-MRC scale). The ASIA motor score range is between 0 and 100 (normal).
次要结局
- ASIA(12 months)
- ASIA sensory score(12 months)
- Spasticity(Baseline, 15 days, 6 months, 12 months)
- Pain(Baseline, 15 days, 6 months, 12 months)
- Independence Measures and Quality of life(12 months)
- Neurophysiological Measures(6 months and 12 months)
- Safety(15, 30, 60, 90, 120, 150, 180, 360 days)
研究者
Antonio Oliviero
MD, PhD, Neurologist
Hospital Nacional de Parapléjicos de Toledo