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    The EU Clinical Trials Register currently displays   41470   clinical trials with a EudraCT protocol, of which   6815   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2019-002632-90
    Sponsor's Protocol Code Number:OF_NEIR_CT1
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-07-03
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-002632-90
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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
    A.4.1Sponsor's protocol code numberOF_NEIR_CT1
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of Sponsor"Olainfarm" AS
    B.1.3.4CountryLatvia
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support"Olainfarm" AS
    B.4.2CountryLatvia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJSC Biomapas
    B.5.2Functional name of contact pointProject Management Team
    B.5.3 Address:
    B.5.3.1Street AddressSavanoriu av. 109
    B.5.3.2Town/ cityKaunas
    B.5.3.3Post codeLT-44208
    B.5.3.4CountryLithuania
    B.5.4Telephone number+37037 366330
    B.5.5Fax number+37037 366750
    B.5.6E-mailpofne811@biomapas.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Neiromidin
    D.2.1.1.2Name of the Marketing Authorisation holder "Olainfarm" AS
    D.2.1.2Country which granted the Marketing AuthorisationLatvia
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNeiromidin
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIPIDACRINE
    D.3.9.1CAS number 90043-86-0
    D.3.9.3Other descriptive nameIPIDACRINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB34851
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Lumbosacral radiculopathy
    E.1.1.1Medical condition in easily understood language
    Nerve root pain
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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
    E.2.2Secondary objectives of the trial
    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)
    E.2.3Trial contains a sub-study No
    E.3Principal 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 of lumbosacral radiculopathy as evidenced by
    imaging (magnetic resonance imaging or computed tomography, or Xray)
    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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary end point(s)
    The change in total ODI score from baseline (Day 0) to Week 6
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline ( Day 0) to Week 6
    E.5.2Secondary 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
    E.5.2.1Timepoint(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
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Russian Federation
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 338
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state158
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 292
    F.4.2.2In the whole clinical trial 358
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard care
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-16
    P. End of Trial
    P.End of Trial StatusOngoing
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