EUCTR2021-006503-15-PL招募中1 期
A prospective, randomised, double-blinded, placebo-controlled study investigating the safety and tolerability of STA363 in patients with radiculopathy caused by lumbar disc herniation
Stayble Therapeutics0 个研究点目标入组 24 人开始时间: 2022年12月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent prior to any study-related procedures
- •2. Patient has a single subligamentous posteriolateral lumbar disc herniation (protrusion or extrusion) of
- •any lumbar disc below L1/L2 diagnosed by clinical symptoms and/or physical findings and confirmed by
- •3. Patient has symptoms and/or physical findings consistent with a unilateral radiculopathy affecting the impaired nerve root
- •4. Patient has leg pain of the dermatome consistent with the nerve root affected by the herniation
- •5. The herniated disc is 3 or lower on the Pfirrmann scale (grade 1-5)
- •6. Patient has experienced symptoms of a herniated disc for at least 6 weeks prior to randomisation
- •without sufficient relief with pain medications and other conservative therapies
- •7. Ability to understand the written and verbal information about the study
- •8. Male and female patients 18 years or older but 50 years or younger
- •9. Women of childbearing potential eligible if using effective contraceptives
- •10. Patient has a body mass index (BMI) of =18 to =35 kg/m2
- •11. Patients who meet all the following NRS selection criteria for radicular leg pain:
- •a. Presence of at least 5 pain NRS assessments (entries) for 7 consecutive days
- •b. NRS daily pain scores between 3-9
- •c. Not more than 2 NRS scores of «3»
- •Note! Patients must be blinded to the above described NRS inclusion criteria 11b and 11c.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Treatment with any investigational product within 3 months prior to the screening visit
- •2. Patient has a sequestered lumbar disc herniation or transligamentous/ herniation confirmed by MRI
- •3. Patient has a bulging disc
- •4. Patient has experienced symptoms of lumbar disc herniation for more than 6 months
- •5. Patient has 2 or more symptomatic lumbar disc herniations (presence of non-symptomatic herniations
- •in addition to the symptomatic herniation is allowed)
- •6. Patient has cauda equina syndrome
- •7. Previous intradiscal therapeutic intervention of the index disc or has had any lumbar spine surgery
- •8. Presence of lumbar spine disease and/or clinically significant deformity other than a lumbar disc
- •herniation which, in the opinion of the investigator, will affect evaluation of safety and/or efficacy
- •9. Untreated, ongoing active infection and/or discitis
- •10. Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or
- •an active systemic infection.
- •11. Evidence of prior lumbar vertebral body fracture or trauma.
- •12. Spondylolisthesis or retrolisthesis grade 2 and above or spondylolysis at the index or adjacent level(s).
- •13. Lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the index disc.
- •14. Patients previously included in the study.
- •15. Patients suffering from psychosomatic pain in the opinion of the Investigator.
- •16. Patients requiring continuous treatment with warfarin or other anticoagulant therapy.
- •17. Known alcohol and/or drug abuse.
- •18. Pregnant or lactating females, or intention to become pregnant within the study period.
- •19. Known allergy or intolerance to the contrast agent Omnipaque®.
- •20. Known opioid allergy or intolerance.
- •21. Any other condition that, in the opinion of the Investigator, precludes the patient from taking part in
- •this study.
- •22. Any specific contraindication for MRI such as claustrophobia, intracranial clips or pacemakers.
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