Disease or acquired damage to the central nervous system frequently causes disabling spasticity and central neuropathic pain (NP), both of which are frequent in multiple sclerosis (MS) and spinal cord injury (SCI). Patients with MS and SCI often request treatment with cannabis-based medicine (CBM). However, knowledge about effects, side effects, choice of active cannabinoids (Δ9-tetrahydrocannabinol (THC), cannabidiol (CBD) alone or in combination), and doses of CBM remains limited. Using a double-blind, parallel design in a national multicenter cohort, this study examines the effect of CBM on spasticity and NP. Patients are randomized to treatment with capsules containing either THC, CBD, THC and CBD, or placebo. Primary endpoints are patient-reported pain and spasticity on a numerical rating scale. Other endpoints include quality of life and sleep, depression and anxiety, and relief of pain and spasticity. Side-effects of CBM are described. In a sub-study, the pharmacodynamics (PD) and pharmacokinetics (PK) of oral capsule CBM are examined. We expect that the study will contribute to the literature by providing information on the effects and side-effects of CBD, THC, and the combination of the two for central neuropathic pain and spasticity. Furthermore, we will describe the PD/PK of THC and CBD in a patient population.

中文翻译：

---

基于大麻的药物对多发性硬化症和脊髓损伤患者神经性疼痛和痉挛的影响：国家多中心双盲、安慰剂对照试验的研究方案

中枢神经系统的疾病或获得性损伤经常导致致残性痉挛和中枢神经性疼痛 (NP)，这两种情况在多发性硬化症 (MS) 和脊髓损伤 (SCI) 中都很常见。MS 和 SCI 患者经常要求使用基于大麻的药物 (CBM) 进行治疗。然而，关于作用、副作用、活性大麻素（Δ9-四氢大麻酚 (THC)、大麻二酚 (CBD) 单独或组合）的选择以及 CBM 剂量的知识仍然有限。本研究在全国多中心队列中使用双盲、平行设计，检查 CBM 对痉挛和 NP 的影响。患者随机接受含有 THC、CBD、THC 和 CBD 的胶囊或安慰剂治疗。主要终点是患者报告的疼痛和痉挛的数值评定量表。其他终点包括生活和睡眠质量、抑郁和焦虑以及疼痛和痉挛的缓解。描述了 CBM 的副作用。在一项子研究中，检查了口服胶囊 CBM 的药效学 (PD) 和药代动力学 (PK)。我们预计该研究将通过提供有关 CBD、THC 以及两者结合治疗中枢神经性疼痛和痉挛的影响和副作用的信息，为文献做出贡献。此外，我们将描述患者群体中 THC 和 CBD 的 PD/PK。及两者合用治疗中枢神经性疼痛及痉挛。此外，我们将描述患者群体中 THC 和 CBD 的 PD/PK。及两者合用治疗中枢神经性疼痛及痉挛。此外，我们将描述患者群体中 THC 和 CBD 的 PD/PK。