Clinical trial NCT01019824 (phase 3, status: completed)
Conditions: pain
ICD codes: N50.82, R07.2, R07.82, R10.13, R10.33, R14.1, R52
Drugs: ralfinamide
SMILES: C[C@H](NCC1=CC=C(OCC2=CC=CC=C2F)C=C1)C(N)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must meet all of the following inclusion criteria to be eligible for
             enrolment into the study:

               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.

        Exclusion Criteria:

          -  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. 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.

             5. History or current diagnosis of positive test for Hepatitis B or C (unless
             vaccinated).

             6. 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).

             7. 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.

             8. Concomitant disease likely to interfere with the study drug (e.g. capable of
             altering absorption, metabolism or elimination of drugs).