Efficacy and Safety of Ralfinamide in Patients With Chronic Neuropathic Low Back Pain
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Ralfinamide
Intervention type(s): Drug
Intervention description(s): Ralfinamide Oral Tablets, 160 or 320 mg per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nerve compression; compression radiculopathy; post-traumatic/post-surgical lumbar radiculopathy