Ralfinamide in patients with low back pain

• Research type

  Research Study

• Full title

  Efficacy and safety of two fixed doses (160 or 320mg/day) of ralfinamide in patients with chronic neuropathic low back pain. A multicentre, double-blind, randomised, placebo-controlled, 12-week study with long-term extension

• IRAS ID

  14373

• Sponsor organisation

  Newron Pharmaceuticals S.p.A.

• Eudract number

  2008-006176-30

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Neuropathic pain is caused by damage or dysfunction in one or more of the nerves. It is estimated that about 1 in 100 people in the UK have persistent (chronic) neuropathic pain. In most cases there is no specific injury or damage to tissues that cause the pain. Instead, the function of the nerve itself is affected so it continues to send pain Ó?signals? to the brain. Nociceptive pain (resulting from tissue damage) can be treated with anti-inflammatory drugs and other pain relief medication. However, neuropathic pain does not respond well to this treatment and the condition remains largely untreated.The sponsor of this clinical trial, Newron Pharmaceuticals S.p.A., has developed a new drug called ralfinamide which works by blocking pain receptors. This trial aims to assess the safety, tolerability and analgesic (pain killing) efficacy of ralfinamide. Around 400 men and women aged 18-85 suffering from chronic neuropathic low back pain due to nerve compression will be recruited from 65 centres in 7 countries. The patients will be randomised (like tossing a coin) to 1 of 3 treatment groups
  160 mg ralfinamide per day
  320 mg ralfinamide per day
  placebo (tablets containing no drug)
  The study is double blind meaning that neither the patient nor their doctor will know which group they have been allocated to. Patients will be involved in the study for a total of 14 weeks, consisting of a 7-day screening period, followed by a 12-week treatment period and a 1-week post-treatment evaluation period. Visits to the study site will occur at weeks 2, 4, 6, 9 and 12 (or at early discontinuation from the study).As there is currently no approved drug therapy for treating this type of chronic neuropathic low back pain, it is hoped that this clinical trial demonstrates that ralfinamide is effective in this patient population.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  09/H0907/14

• Date of REC Opinion

  13 Mar 2009

• REC opinion

  Further Information Favourable Opinion