EFFICACY AND SAFETY OF TWO FIXED DOSES (160 OR 320 MG/DAY) OF RALFINAMIDE IN PATIENTS WITH CHRONIC NEUROPATHIC LOW BACK PAIN. A MULTICENTER, DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED 12-WEEK STUDY WITH LONG-TERM EXTENSION.

Newron Pharmaceuticals S.p.A.21 个研究点分布在 1 个国家目标入组 0 人开始时间: 2009年1月3日最近更新: 2013年11月4日

试验速览

阶段: 3 期
状态: 已完成
发起方: Newron Pharmaceuticals S.p.A.
试验地点: 21
主要终点: The efficacy of ralfinamide will be based on the mean change from baseline to Week 12 or endpoint (in case of premature termination) on the 11-point Likert categorical scale (daily pain assessment).

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

分配方式: Computer generated randomization
盲法: Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

入选标准

•1.Patient presents in the physical/neurological examination with low back pain with or without radiation into the lower limb that must display a topography compatible with the L1 to S1 territory and/or respective sensory or motoric impairments.
•2.Patient must have chronic neuropathic low back pain with a minimum intensity of ?40 mm?
•(moderate) or greater on the Visual Analogue Scale (VAS; 100-mm) at screening, and an average of ?40 mm?
•or more at baseline (based on prior 7 days).3.The onset of pain has occurred at least three months, but not longer than 3 years, prior to the screening visit, as assessed by the investigator in the patient?s medical history.4.Patient is affected by current neuropathic pain (pain provoked by a lesion of the peripheral nervous system).
•The diagnosis should be made by a neurologist/anaesthesiologist/pain specialist and based on history, clinical evaluation and/or laboratory findings (rule out systemic cause, e.g., hypothyroidism, rheumatoid arthritis, nephropathy, diabetes [MNSI score >2]) 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 pain due to spinal root compression.
•If radiologic data supporting the diagnosis had been obtained previously it should be documented in the patient?s records.
•In case radiologic examinations are not available, the Investigator should consider performing these examinations, if necessary to support the diagnosis, during the screening phase.5.Patient has one of the following causes of neuropathic low back pain: Non-cancer lumbar pain due to compression radiculopathy or post-traumatic/post-surgical lumbar radiculopathy.
•6.Patient?s low back pain has a clear neuropathic component, as indicated by a rating on the Pain Detect Questionnaire (PD-Q) of greater than 18.7.Patient is 18-85 years of age, inclusive.
•8.Patient is willing and able to understand and sign an approved Informed Consent Form.

排除标准

•1.Females who are pregnant or lactating, or of childbearing potential, defined as follows: surgically sterilized for less than one year; aged ≥ 50 years and post-menopausal condition started less than 24 months prior to the screening visit; or aged < 50 years and post-menopausal condition started less than 24 months prior, and/or post-menopausal status has not been confirmed by determination of the serum levels of FSH and 17-β estradiol; or fecund and not practicing double contraception method (e.g., hormonal contraceptive plus barrier method).
•2.Patients with any other cause of peripheral or central neuropathic pain (including psychogenic and nociceptive pain), pain due to metabolic (including diabetes; MNSI score > 2) infectious or proliferative diseases, or pain due to any condition that is as severe as the neuropathic pain.3.Patients with a history of migrating pain and former mononeuropathy or neuralgias in other anatomical territories.4.Based on medical history or ophthalmological examination, patient has one of the following conditions:?is albino?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), ?severe diabetic retinopathy, or ?moderate proliferative retinopathy.5.Patients with severe trophic changes, severe swelling, joint deformities or stiff joint with limited passive movement, or patients who may be candidates for back surgery within 52 weeks after baseline.
•6.History or current diagnosis of positive test for Hepatitis B or C (unless vaccinated).7.Clinically significant, uncontrolled gastrointestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease (including non well-controlled hypertension), asthma, uncompensated chronic obstructive pulmonary disease (COPD), severe uncontrolled diabetes (HbA1c > 10.0).
•8.Second- or third-degree atrioventricular block or sick sinus syndrome, uncontrolled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction within 3 months of the screening visit, significant ECG abnormalities or QTc ≥ 450 msec (males) or ≥ 470 msec (females), where QTc is based on Bazett?s correction method.9.Concomitant disease likely to interfere with the study drug (e.g. capable of altering absorption, metabolism or elimination of drugs).10.History of psychosis (e.g. schizophrenia or psychotic depression) or any current DSM-IV Axis I diagnosis including dementia, depression (BDI > 13), psychosis, anxiety disorders, mental retardation, etc.11.Neoplastic disorder which is either active or has been in remission for less than one year.12.History or concomitant diagnosis of seizure disorder, or severe dizziness or fainting on standing due to postural hypotension.13.History of allergic response, hypersensitivity or contraindications to anticonvulsant drugs or MAO-B inhibitors, history of prior drug interactions, or past characterisation as a ?slow metaboliser?.14.Treatment with potentially hepatotoxic (e.g., tamoxifen), nephrotoxic, or antineoplastic drugs within the past the 6 months, depot neuroleptics in the previous 6 months, or oral neuroleptics in the 30 days prior to randomisation.15.Patients who participated in prior trials with ralfinamide or received any investigational drug or device within 30 days prior to randomisation or 5 half-lives, whichever is longer.
•Use of an investigational drug or device other than ralfinamide during the study is not permitted.16.Treatment with guanethidine or other sympathetic blockers in the 3 months prior to randomisation.
•Use of β-blockers for an indication other than pain will be permitted, provided they are given at a stable dose for at least one month prior to screening.
•17.Treatment within 4 weeks preceding randomisation with any of the following: drugs known to significantly inhibit or induce enzymes (e.g., barbiturates, phenothiazines, etc.), opioids, tri- or tetra-cyclic antidepressants, SNRIs (e.g., venlafaxine, duloxetine), MAO inhibitors (e.g., selegiline), tramadol, dextromethorphan, meperidine derivatives, neuro-stimulating devices, such as spinal cord stimulation (SCS), transcutaneous electrical nerve stimulation (TENS) or peripheral nerve stimulation (PNS), acupuncture, homeopathic remedies for pain or any kind of surgical treatment or blockade for the pain.
•Treatment with SSRIs, NSAIDs (including COX-inhibitors) and minor analgesics (e.g., paracetamol) will be permitted if taken at a stable dose from at least 4 weeks prior to study start (screening), provided that the dose will not be changed during the study.
•18.Treatment with antiepileptic drugs (AEDs, e.g. pregabalin, gabapentin, carbamazepine, etc.), benzodiazepines (except if used as hypnotic at a stable dose), mexiletine, skeletal muscle relaxants, steroids (except if used for allergies, asthma, etc.
•and maintained at a stable dose), capsaicin, coumarin anticoagulants, topical analgesics or injection of local anesthetics in the 2 weeks prior to randomisation.
•19.Any abnormality that the investigator deems to be clinically relevant, either on medical history, physical examination, ECG, or diagnostic laboratory test, especially ASAT (SGOT), ALAT (SGPT), γGT or bilirubin, during the screening period, greater than the upper limit of normal (ULN).
•Patients whose test results are normal on repeat examination (Day -4) would be eligible for the study.20.In the judgment of the Investigator, the subject is likely to be noncompliant or uncooperative during the study.

结局指标

主要结局

The efficacy of ralfinamide will be based on the mean change from baseline to Week 12 or endpoint (in case of premature termination) on the 11-point Likert categorical scale (daily pain assessment).

时间窗: The efficacy of ralfinamide will be based on the mean change from baseline to Week 12 or endpoint (in case of premature termination) on the 11-point Likert categorical scale (daily pain assessment).

次要结局

??Responder? rates, based on the proportion of patients experiencing a 30% or a 50% improvement from baseline to endpoint in mean pain rating on the 11-point Likert scale (daily pain assessment), ?Change from baseline in the subject?s perception of of the impact of pain on sleep and activity (11-point Likert scales), ?Change from baseline in the Visual Analogue Scale (VAS; 100-mm), as rated by the patient, ?Time to first use and cumulative number of days of usage of rescue pain medication.(??Responder? rates, based on the proportion of patients experiencing a 30% or a 50% improvement from baseline to endpoint in mean pain rating on the 11-point Likert scale (daily pain assessment), ?Change from baseline in the subject?s perception of of the impact of pain on sleep and activity (11-point Likert scales), ?Change from baseline in the Visual Analogue Scale (VAS; 100-mm), as rated by the patient, ?Time to first use and cumulative number of days of usage of rescue pain medication.)

研究者

发起方

Newron Pharmaceuticals S.p.A.

研究点 (21)

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