Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled crossover study to evaluate the analgesic efficacy, safety and tolerability of repeated doses of topical VMD-3866 in patients with chemotherapy-induced peripheral neuropathy (CIPN).
IRAS ID
1011031
Contact name
Jay Wu
Contact email
Sponsor organisation
VM Therapeutics LLC
Clinicaltrials.gov Identifier
Research summary
The study medicine, VMD-3866, is an experimental new medicine for treating pain caused by chemotherapy-induced peripheral neuropathy (CIPN). CIPN occurs when chemotherapy drugs that kill cancer cells also damage the nerves that send messages between the brain and the rest of the body. This damage causes the nerves that send messages for pain to become over-active. CIPN includes a wide range of symptoms, but people often have tingling, pins and needles, numbness and pain in the hands and feet, muscle weakness, and problems with balance, walking, and coordination. \n\nWe hope that VMD-3866 will work by blocking certain proteins (called calcium channels) in the nerves, which will lower the activity of the nerves and therefore reduce pain.\n\nWe’ll test repeated doses of VMD-3866 as a gel to find out its side effects and if it reduces pain in patients with CIPN.\n\nThis is a study in up to 16 participants with CIPN, aged 18–80 years. Participants will have 2 study sessions. In each session, eligible participants will apply VMD-3866 gel or placebo gel (a dummy medicine that looks the same as the study medicine but has no active ingredient) to the skin on the feet/lower calves affected by CIPN once a day for up to 8 days. Participants will apply VMD-3866 gel/placebo gel either at the clinic or at home. \n\nParticipants may have up to 3 skin biopsies where they’ll have a small sample of the skin taken from the lower leg. \n\nParticipants will take about 7 weeks to finish the study. They’ll make up to 6 outpatient visits and have a follow-up telephone call.\n\nA pharmaceutical company, VM Therapeutics, is funding the study. \n\nThe study will take place at 1 centre in London.
REC name
North East - York Research Ethics Committee
REC reference
25/NE/0024
Date of REC Opinion
3 Apr 2025
REC opinion
Further Information Favourable Opinion