利莫那班对脊髓损伤患者手功能的影响
Effect of Rimonabant on Hand Function in Patients With Spinal Cord Injury
颈段脊髓损伤常导致手部活动受限,目前缺少有效药物。这项研究拟招募 8 名患者,每天口服 5 毫克利莫那班,持续 90 天,并每 15 至 30 天回院复查。研究为单臂设计,即所有参与者都用药、没有对照,主要观察手部运动与操作能力是否改善,以及药物的安全性和不良反应。这是利莫那班用于脊髓损伤的早期探索,样本量很小,结果尚不能确定疗效。
为什么推荐给您:已知药物用于脊髓损伤这一新适应证的早期小样本单臂探索,属值得关注的转化尝试。
不需要生物学背景,多打比方
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摘要Abstract
Brief summary: This is an one arm study to be conducted in spinal cord injury patients. The goal of this clinical trial is to learn if rimonabant improves hand motor and performance function in patients with cervical spinal cord injury. It will also learn about the safety of rimonabant. Participants will: Take 5 mg of rimonabant every day for 90 days. Visit the clinic once every 15-30 days for checkups and tests.
Conditions: Cervical Spinal Cord Injury
Interventions: drug: Rimonabant
Phase: Phase 1, Phase 2
Enrollment: 8 (estimated)
Sponsor: Sinfatin S.L (industry)
Countries: Spain
Status: active not recruiting