A study of EMA401 for pain due to chemotherapy induced nerve damage

• Research type

  Research Study

• Full title

  A Phase 2 open label biomarker study of angiotensin II type 2 receptor antagonist EMA401 for the treatment of pain in patients with chemotherapy-induced peripheral neuropathy

• IRAS ID

  92310

• Contact name

  Praveen Anand

• Eudract number

  2011-004033-13

• Research summary

  Nerve damage (peripheral neuropathy) can be a side effect of cancer chemotherapy and can cause short or long-term problems ranging from mild to severe. Patients may have skin pain and abnormal sensory symptoms like being very sensitive to touch. These can be difficult to treat, and current drugs are often not effective and have side-effects. Research studies done at Hammersmith Hospital have shown that nerve fibres damaged after chemotherapy can regrow abnormally, and that this abnormal growth may be related to the pain due to peripheral neuropathy. EMA401 is a potential new treatment for reducing pain caused by peripheral neuropathy. It has shown results in laboratory models, and laboratory-grown human cells. This study will test the effectiveness of EMA401 in humans in reducing peripheral neuropathy pain specifically caused by chemotherapy. It will also look at whether EMA401 helps damaged nerve fibres grow normally. Participation in this study will involve a screening visit, 3 visits to the site during treatment, and 1 follow up visit 28 days post treatment. Patients will take two 50mg capsules of EMA401 in the morning and in the evening, every day for 28 days. Patients can continue taking their current stable doses of pain management drugs. At clinic visits patients will have various sensory tests to assess the level of their pain due to peripheral neuropathy, and their ability to sense various stimuli. The effect of EMA401 will also be assessed by asking patients to score their pain from 0 to 10 (0 = no pain, and 10 = pain as bad as they can imagine) twice a day for the duration of the study. Patients in this study must have had chemotherapy with platinum or taxane class drugs. While other chemotherapies can cause peripheral neuropathy, restricting study enrolment to these allows a more standardised population.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  11/LO/2042

• Date of REC Opinion

  6 Feb 2012

• REC opinion

  Further Information Favourable Opinion