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.

ewron Pharmaceuticals S.p.A.0 个研究点目标入组 390 人开始时间: 2009年4月28日最近更新: 2012年3月19日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 390

研究概览入排标准研究者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

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

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 a score of 40 mm” on each of the 5-7 days of diary recording prior to baseline.
•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.Patients aged 18-85 years, inclusive. Patients greater than 85 years of age may be enrolled if they are in good health and approved by the Medical Monitor.
•8.Patient is able to understand and signs an approved Informed Consent form.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•The exclusion criteria has been abbreviated (for full details please see the protocol):
•1.Females who are pregnant or lactating, or of childbearing potential.
•2.Patients with any other cause of peripheral or central neuropathic pain , pain due to metabolic, 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:
•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),
•moderate or 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, 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, where QTc is based on Bazett’s correction method.
•9.Concomitant disease likely to interfere with the study drug.
•10.History of psychosis or any current DSM-IV Axis I diagnosis.
•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.
•14.Treatment with potentially hepatotoxic, 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.
•16.Treatment with guanethidine or other sympathetic blockers in the 3 months prior to randomisation.
•17.Treatment within 4 weeks preceding randomisation with any of the following: drug known to significantly inhibit or induce enzymes (e.g., barbiturates, phenothiazines, etc.), opioids (other than tramadol), tri- or tetra-cyclic antidepressants, SNRIs (e.g., venlafaxine, duloxetine), MAO inhibitors (e.g., selegiline), 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 s

研究者

发起方

ewron Pharmaceuticals S.p.A.

相似试验

进行中（未招募）

不适用

EUCTR2008-006176-30-ATewron Pharmaceuticals S.p.A.390

进行中（未招募）

不适用

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 - NDChronic neuropathic low back painMedDRA version: 9.1Level: LLTClassification code 10054095Term: Neuropathic pain

EUCTR2008-006176-30-ITEWRON PHARMACEUTICALS560

已完成

3 期

A clinical trial to study the effects of Ralfinamide in patients with chronic neuropathic low back pain.

CTRI/2009/091/000078ewron Pharmaceuticals S.p.A.

进行中（未招募）

不适用

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.Chronic neuropathic low back pain.MedDRA version: 9.1Level: LLTClassification code 10054095Term: Neuropathic pain

EUCTR2008-006176-30-DEewron Pharmaceuticals S.p.A.390

进行中（未招募）

1 期

Efficacy and Safety of Fixed-Dose Combinationatorvastatin / amlodipine / perindopril versus Fixed-Dose Combination of atorvastatin / amlodipine in Patients with Hypertension and Dyslipidemia.Hypertension and dyslipidemiaMedDRA version: 20.0Level: HLTClassification code 10020774Term: Vascular hypertensive disorders NECSystem Organ Class: 100000004866MedDRA version: 21.0Level: LLTClassification code 10058110Term: DyslipidemiaSystem Organ Class: 100000004861

EUCTR2014-005378-12-ITINSTITUT DE RECHERCHES INTERNATIONALES SERVIER854