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The aim of the study is to determine if an experimental drug, ralfinamide, relieves your neuropathic low back pain, and if it demonstrates superiority to placebo, a "dummy" or sugar pill that contains no active medication. Ralfinamide, given as either 160 mg/day or 320 mg/day, taken in a divided dose twice-a-day, will be compared with placebo. If you are randomly (by chance) selected to receive placebo, you will receive this medication throughout the treatment period of the study. Data from this study will provide essential information for choosing the doses of ralfinamide to be used in the treatment of this type of pain and potentially other types of pain.
Ralfinamide has been shown to be an effective analgesic in a number of animal models of neuropathic pain. These observed effects of ralfinamide may have been achieved by targeting both hyperactivity of peripheral sensory neurons, through voltage-dependent, Na+-channel blockade [Stummann et al., 2005] and Ca++-channel blockade, and sensitization of central neurons, through NMDA-receptor modulation.
Evidence of efficacy in mixed peripheral neuropathic pain syndromes has been demonstrated in Study 001 [Anand et al., 2008]. In particular patients with neuropathic pain due to nerve compression (e.g., compression radiculopathy, lumbar spinal stenosis, sciatic nerve compression, spinal root compression, intercostal neuralgia) showed response to ralfinamide treatment. In this sub-population, statistically significant improvements in severity of pain, as measured on the VAS and 11-point Likert scales, as well as a greater proportion of patients meeting "responder" criteria, compared to the placebo group, were noted with ralfinamide treatment. Similarly, patients in the study classified as having neuropathic low back pain also showed significant benefit from treatment with ralfinamide; therefore, the focus of the current study is on this indication.
The current study will evaluate the safety, tolerability and analgesic efficacy of ralfinamide in patients with chronic neuropathic low back pain due to nerve compression, i.e., compression radiculopathy or post-traumatic/post-surgical lumbar radiculopathy. It should also be noted that no current drug therapy has global regulatory approval for treating this type of chronic neuropathic low back pain; therefore, should ralfinamide prove effective in this patient population, it would be satisfying an unmet medical need.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Active, not recruiting
Newron Pharmaceuticals S.p.A.
Published on BioPortfolio: 2014-08-27T03:17:44-0400
The purpose of this study is to examine the effects of various increasing doses of Ralfinamide in patients with neuropathic pain.
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