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

Phase 1

Conditions: umbosacral radiculopathy
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2019-002632-90-LV

Lead Sponsor: Olainfarm AS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 458

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

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 < 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)
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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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