2024-518824-56-00招募中3 期
Pregabalin or Baclofen in Spastic Motor Behavior Treatment After SCI (PoBSCI), Prospective, Double-Blind, Randomised Drug Study
Fakultni Nemocnice V Motole1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年10月20日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Per-patient average of MES scores across the 30 days treatment.
研究概览
简要总结
To prove better efficacy of Pregabalin in SCI patients with predominant phasic (dynamic) component of spastic motor behaviour compared to Baclofen.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Sub-acute (2-40 days after the injury) cervical or thoracic (NLI C4-T10) spinal cord lesion (SCI), complete or incomplete (AIS A-C), with severe spastic motor behaviour (static or dynamic)
- •Age: 18-75 years old
- •MAS or MES 3 or higher during at least 3 days from 5
- •Ability and will to cooperate in the study
- •Written informed consent. If the patient is only able to consent orally a witness signs and confirms the patient’s consent.
- •Absence of serious comorbidities influencing spastic motor behaviour (serious infection, recent surgery…)
- •Hemodynamic and clinical stability
- •Males and Females of childbearing potential willing to use highly effective method of contraception (hormonal contraception, intrauterine device or sexual abstinence) during the treatment period and for at least one month after the last dose of study drug.
排除标准
- •History of hypersensitivity to IMP (Pregabalin and/or Baclofen)
- •Neuropathic pain stronger than VAS 5
- •Previous medication for spastic motor behaviour or neuropathic pain or epilepsy (pregabalin, neurontin, baclofen, rivotril, sirdalud...)
- •Pregnancy or breastfeeding
- •Renal dysfunction (creatinine level over 120 umol/l, urea level over 10 mmol/l)
- •Liver dysfunction (liver enzymes over 2,5 ukat/l)
- •BMI ˃ 35kg/m2
结局指标
主要结局
Per-patient average of MES scores across the 30 days treatment.
Per-patient average of MES scores across the 30 days treatment.
次要结局
- Per-patient average of MAS scores across the 30 days treatment
- Proportion of days when MES score is 3 or higher.
- Proportion of days when MAS score is 3 or higher.
- ADL evaluated by SCI-SET (relevant questions).
- Functioning assessed by the Spinal Cord Independence Measure (SCIM-III).
- Quality of life evaluated by WHOQOL-BREF questionnaire.
研究者
Principal Investigator
Scientific
Fakultni Nemocnice V Motole
研究点 (1)
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