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    The EU Clinical Trials Register currently displays   36111   clinical trials with a EudraCT protocol, of which   5936   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2004-000557-35
    Sponsor's Protocol Code Number:NW-1029/001/II/2003
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-22
    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 ConcernedUK - MHRA
    A.2EudraCT number2004-000557-35
    A.3Full title of the trial
    A phase II, multi centre, pilot, randomised, ascending dose, double -blind, placebo controlled, dose titration study to determine the safety, maximum tolerated dose and preliminary evidence of efficacy of ralfinamide in the range of 80-320mg/day in patients with neuropathic pain.
    A.4.1Sponsor's protocol code numberNW-1029/001/II/2003
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNewron Pharmaceuticals SpA
    B.1.3.4CountryItaly
    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
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameRalfinamide 40mg Tablets
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNRalfinamide
    D.3.9.1CAS number 202825-45-4
    D.3.9.2Current sponsor codeNW-1029
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    Neuropathic pain
    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 determine the clinical tolerability and the maximum tolerated dose of ralfinamide administered at increasing doses in the range of 80-320mg/day in patients with neuropathic pain.
    E.2.2Secondary objectives of the trial
    To determine preliminary evidence of the efficacy of ralfinamide in the range of 80 320mg/day in patients with neuropathic pain.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Male or female patients aged 18-85 years, inclusive. If female, they must be post-menopausal for at least 12 months or surgically sterilized or have undergone hysterectomy.

    2. Patients affected by current neuropathic pain (pain provoked by a lesion of the peripheral nervous system). The diagnosis should be made by a pain neurologist and based on history, clinical and/or laboratory findings in accordance with the taxonomy of the diagnostic criteria documented in the International Association for the Study of Pain (IASP) Classification of Chronic Pain. A neurological disease must be directly correlated with pain, including traumatic or ischemic nerve roots disease, nerve roots compression in spine disease, post herpetic neuropathy, diabetic neuropathy, nerve entrapment, traumatic mononeuropathy and polyneuropathy. Central neuropathic pain conditions must not be included. As a generic rule, nerve conduction studies are recommended to provide evidence of peripheral nerve injury. Each of these procedures must be clearly reported in the CRFs.

    3. Patients must have a pain intensity of “forty mm” (moderate) or greater on the Visual Analogue Scale (VAS) 100mm at screening and at baseline, where the onset of pain has occurred at least three months prior to the screening visit, as documented in the patient’s notes.

    4. Patients with neuropathic pain in addition to spontaneous chronic pain may complain of stimulus evoked pain (allodynia, hyperalgesia) or shooting pains. The presence of such additional neuropathic symptoms will be recorded and the response to the treatment monitored.

    5. Willing and able to understand and sign an approved Informed Consent form.
    E.4Principal exclusion criteria
    15. History of psychosis (e.g. schizophrenia or psychotic depression) or major depression (requiring treatment).

    16. Any current axis I diagnosis including dementia, depression, psychosis, anxiety disorders, mental retardation etc.

    18. History of allergic response to anticonvulsant drugs.

    19. Hypersensitivity or contraindications to MAO-B inhibitors.

    25. Treatment with SNRIs, MAO inhibitors (e.g. selegiline), meperidine derivatives in the 4 weeks prior to randomisation. Treatment with tri- or tetra-cyclic antidepressants will be permitted if taken at a stable dose for at least 4 weeks prior to study start (screening), providing that the dose will not be increased during the study. Treatment with opioids will be permitted if taken at a stable dose for at least 7 days prior to study start (screening), providing that the dose will not be increased during the study.

    Patients with a history or concomitant diagnosis of seizure disorder, prior drug interactions, or past characterisation as slow metabolisers will be excluded.

    27. Treatment with benzodiazepines (except if used as hypnotic), mexiletine, skeletal muscle relaxants, steroids (use for allergies is permitted), capsaicin, coumarin, anticoagulants and topical analgesics in the 2 weeks prior to randomisation. NSAIDs and minor analgesics (i.e. paracetamol) will be permitted if taken at a stable dose from at least 4 weeks prior to study start (screening), providing that the dose will not be changed during the study, and as rescue medication any time during the trial, based on the clinical judgement of the investigator. Tramadol is also allowed as rescue medication, provided it is not administered for more than two consecutive days during the same week. Treatment with antiepileptic drugs (AEDs) will be permitted if taken at a stable dose for at least 4 weeks prior to study start (screening), providing that the dose will not be increased during the study.

    28. Treatment with neurostimulating devices such as spinal cord stimulation (SCS), transcutaneous electrical nerve stimulation (TENS) or peripheral nerve stimulation (PNS), acupuncture, homoeopathic remedies for pain or any kind of surgical treatment or blockade for the pain in the previous 4 weeks.

    33. Patients who have a history of susceptibility to CNS adverse events, or who have experienced clinically important CNS adverse events on compounds mechanistically similar to ralfinamide e.g. carbamezapine, oxcarbazepine, lamotragine, phenytoin, topiramate, other anti-epileptics such as gabapentine, valproic acid, tiagabine, etc., should be excluded.

    34. Patients with uncontrolled hypertension or those patients in whom hypertension has been recently diagnosed (less than 6 months) will be excluded from participation in the trial. Furthermore, patients with controlled hypertension who are included in the trial will be reminded to refrain from tyramine-rich food, and investigators will be asked to ensure that the blood pressure will be in the normal range in these patients prior to any dose increase.

    35. Ophthalmologic history: Patients with the following conditions will be excluded: albino patients, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity i.e. 20/70, retinitis pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular inflammation (uveitis), diabetic retinopathy.
    E.5 End points
    E.5.1Primary end point(s)
    Not Applicable
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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.8.3 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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    The end of the trial will be at the last visit of the last subject undergoing the trial
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 144
    F.4.2.2In the whole clinical trial 144
    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)
    Not Applicable
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2004-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-06-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-04-27
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