Lumbosacral radiculopathy
Conditions
Sponsors
"Olainfarm" AS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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: •epilepsy, •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 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) infection. 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 injury. 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 within 30 days before the enrolment. 5)Epidural steroid injections within 30 days before the enrolment. 6)Treatment with benzodiazepines or tricyclic antidepressants within 20 days before the enrolment. 7)Treatment with anticonvulsants, myorelaxants or opioid analgesics within 12 days before the enrolment. C. Other exclusion criteria 1)Problems with information perception and/or completing the questionnaires. 2)Unreliable patients including non-compliant patients, patients with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as patients unwilling to abide by the requirements of the Protocol. 3)Patient is currently participating in another clinical study or has participated in a clinical study within 30 days before the enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of Neiromidin 20 mg tablets relative to placebo for the change in disability score (as assessed using Oswestry Disability Index [ODI]) from baseline to the end of 6-week treatment in patients with lumbosacral radiculopathy;Secondary Objective: 1. To evaluate the effect of Neiromidin 20 mg tablets on low back pain and leg pain as assessed using the 11-point Numerical Rating Scale (NRS); 2. To evaluate the effect of Neiromidin 20 mg tablets on the change in quality of life as assessed using the EuroQol Five Dimension Five Level Five Dimension (EQ-5D-5L) questionnaire; 3. To evaluate the effect of Neiromidin 20 mg tablets on other parameters of recovery from lumbosacral radiculopathy (i.e., nerve conduction parameters, sensitivity, Achilles reflex, muscle strength); 4. To assess the safety and tolerability of Neiromidin 20 mg tablets; 5. The exploratory study objective is to evaluate the effect of Neiromidin 20 mg tablets on the serum level of brain-derived neurotrophic factor (BDNF). ;Primary end point(s): The change in total ODI score from baseline (Day 0) to Week 6;Timepoint(s) of evaluation of this end point: From baseline ( Day 0) to Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in leg pain intensity on the NRS 2. Change in low back pain intensity on the NRS 3. Change in sensory nerve conduction parameters (conduction velocity, latency, amplitude) 4. Change in motor nerve conduction parameters (conduction velocity, latency, amplitude) 5. Change in late response (F-waves) 6. Change in sensitivity 7. Change in Achilles reflexes 8. Change in muscle strength 9. Whether a patient had “improved”, “much improved” or “very much improved” relative to baseline on each of the Patient Global Impression of Change (PGIC) scale (Yes or No) 10. Change in EQ-5D-5L scores ;Timepoint(s) of evaluation of this end point: 1. From baseline to Week 3 and Week 6 2. From baseline to Week 3 and Week 6 3. From baseline to Week 6 4. From baseline to Week 6 5. From baseline to Week 6 6. From baseline to Week 3 and Week 6 7. From baseline to Week 3 and Week 6 8. From baseline to Week 3 and Week 6 9. At Week 3 and Week 6 10. From baseline to Week 6 | — |
Countries
Czech Republic, Latvia, Poland
Contacts
Public ContactProject Management Team
UAB Biomapas
Outcome results
None listed