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 - ND

• Conditions: Chronic neuropathic low back pain; MedDRA version: 9.1Level: LLTClassification code 10054095Term: Neuropathic pain

• Registration Number: EUCTR2008-006176-30-IT
• Lead Sponsor: EWRON PHARMACEUTICALS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

1. Patient presents in the physical/neurological examination (see Section 6.2.1) 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? at baseline (based on prior 7 days, see Section 5.5). 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. 8. Patient is willing and able to understand and sign 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

Exclusion Criteria

The exclusion criteria has been abbreviated (for full details please see the protocol): 1. Females who are pregnant or lactating, or of childbearing potential (see protocol for details) 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: 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, 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. 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, 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. .......

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objectives of this study are to evaluate the efficacy, safety and tolerability of two doses of orally administered ralfinamide, compared to placebo, in patients with chronic neuropathic low back pain.;Secondary Objective: The following secondary efficacy measures will be used: ?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 in the subject?s perception of the impact of pain on sleep and activity from baseline (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.;Primary end point(s): 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).