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.

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

• Registration Number: EUCTR2008-006176-30-DE
• Lead Sponsor: ewron Pharmaceuticals S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 390

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 a score of 40 mm” on each of the 5-7 days of diary recording priot to baseline (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 / orthopaedist / 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 results of imaging examinations are not available, the Investigator should consider performing these examinations, if necessary to support the diagnosis during the screening phase, prior to randomizing the patient to treatment.
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

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.
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, inflammatory 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),
•moderate or severe diabetic retinopathy, or
•moderate proliferative retinopathy
5. Patients who may qualify for back surgery or any other treatment of the cause of their pain (e.g. disc herniations, mechanical entrapment syndromes) within 52 weeks after baseline, or patients with severe trophic changes, severe swelling, joint deformities or stiff joint with limited passive movement.
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)

Study & Design

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