Ralfinamide in patients with low back pain (extension study)

• Research type

  Research Study

• Full title

  A multicentre, double-blind, randomised, placebo-controlled, extension study to assess the long term safety and efficacy of two fixed doses of ralfinamide (160 or 320) in patients with chronic neuropathic low back pain.

• IRAS ID

  14710

• Sponsor organisation

  Newron Pharmaceuticals S.p.A.

• Eudract number

  2008-006159-39

• 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 study is an EXTENSION to a MAIN study assessing the effect of ralfinamide in around 400 men and women aged 18-85 suffering from chronic neuropathic low back pain due to nerve compression. Patients from the MAIN study will already have been randomised (like tossing a coin) to 1 of 3 treatment groups<ul> <li style="color: 160 mg ralfinamide per day </li> <li style="color: 320 mg ralfinamide per day </li> <li style="color: placebo (tablets containing no drug)</li></ul>Both the MAIN and EXTENSIONS studies are double blind meaning that neither the patient nor their doctor will know which group they have been allocated to. If a patient wishes to participate in the EXTENSION study and are not experiencing any side effects or medical conditions they will continue on their current medication for an additional 40 weeks followed by a drug-free one-week post-study observation period. Study site visits will take place after 4, 10, 16, 22, 28, 34, and 40 weeks and after 41 weeks.The EXTENSION study will allow will allow evaluation of long-term (up to one year of total treatment in the MAIN and EXTENSION studies) safety and efficacy of ralfinamide in a patient population which currently has no approved drug therapy.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  09/H0907/15

• Date of REC Opinion

  14 May 2009

• REC opinion

  Further Information Favourable Opinion