EUCTR2019-002632-90-BG进行中（未招募）1 期
A prospective, double-blind, randomised, placebo-controlled trial on the efficacy and safety of Neiromidin 20 mg tablets in the treatment of patients with lumbosacral radiculopathy
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Olainfarm AS
- 入组人数
- 458
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1)Male or female patients, aged 18-65 years old inclusive at the time of
- •signing the informed consent.
- •2)Low back pain irradiating through vertebral roots to lower limb (L5-S1
- •segments) and lasting for one to six (1-6) months before the enrolment
- •(based on medical history and medical records)and radicular leg pain of
- •moderate to severe intensity (NRS = 6) over the preceding week.
- •3)Diagnosis of lumbosacral radiculopathy supported with objective,
- •documented evidence (magnetic resonance imaging or computed tomography, or X-ray) allowing to reject any significant non-degenerative spine injury.
- •4)ODI 16-60%.
- •5)Females of nonchildbearing potential (postmenopausal [defined as 12
- •months of spontaneous amenorrhea] or pre-menopausal with
- •documented irreversible surgical sterilization or hysterectomy) or
- •childbearing potential (negative pregnancy test at screening and using
- •an effective method to avoid pregnancy, i.e., oral, injectable,
- •transdermal or implanted hormonal contraceptives, vaginal
- •contraceptive ring, intrauterine device/intrauterine system,
- •vasectomised sexual partner [with confirmed negative sperm counts] or
- •true sexual abstinence).
- •6)Signed informed consent.
- •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 458
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A. Concomitant diseases or conditions
- •1)Hypersensitivity to ipidacrine and any of the excipients (i.e., lactose,
- •potato starch, calcium stearate, denatonium benzoate anhydrous,
- •Prosolv® EASYtab SP).
- •2)Contraindications to the use of ipidacrine:
- •extrapyramidal disorders with hyperkinesia,
- •angina pectoris,
- •significant bradycardia,
- •bronchial asthma,
- •intestinal or urinary tract obstruction,
- •exacerbation of gastric ulcer or duodenal ulcer,
- •vestibular disturbances,
- •pregnancy,
- •breast-feeding.
- •3)Rare hereditary problems of galactose intolerance, total lactase
- •deficiency or glucose-galactose malabsorption.
- •4)Cauda equina syndrome.
- •5)Bilateral lumbosacral radiculopathy.
- •6)Severely reduced muscle strength: grade 0 or 1 (Medical Research
- •Council [MRC] Muscle Scale grade) for foot flexors and/or foot extensors
- •and/or extensor hallucis longus of the affected side.
- •7)Demyelinating disease.
- •8)Any disease treated with systemic steroids and/or biological therapy
- •within 12 months before the enrolment.
- •9)Systemic or local infections within two weeks before the enrollment.
- •10)Clinically significant kidney or liver impairment (kidney impairment
- •assessed as eGFR < 45 ml/min/1.73 m², and liver impairment assessed
- •as > 3x upper normal limit for AST and/or ALT).
- •11)Implanted temporary transvenous cardiac pacemaker.
- •12)Inserted peripheral or central venous catheter or device with
- •external wires that are in close proximity to the heart.
- •13)Severe obesity (Body Mass Index > 40 kg/m2).
- •14)Current or previous malignancy of any location (except cured basal
- •cell carcinoma of the skin).
- •15)Immunosuppression or human immunodeficiency virus (HIV)
- •16)Evidence of any significant clinical or laboratory finding, or
- •electrocardiogram test results that make it undesirable for the patient to
- •participate in the study.
- •17)Lumbosacral radiculopathy onset due to a non-degenerative spine
- •18)Mental disease or high-risk for suicide (i.e., suicide attempts in the
- •past or current suicidal ideas).
- •B. Previous, concomitant or planned treatments
- •1)Post-surgery period (lumbosacral spine surgery) of less than three
- •months before the enrolment.
- •2)Surgical interventions planned in the next two months.
- •3)Ipidacrine or any other AChE inhibitor-based therapy within 30 days
- •before the enrolment.
- •4)Use of chiropractice (i.e., spinal manipulation performed on spinal
- •articulations: lumbosacral, sacroiliac, costotransverse and/or
- •costovertebral joints) for the treatment of lumbosacral radiculopathy
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