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 trial medicine (VMD-3866) is an experimental new medicine, applied as a gel on the skin, for treating pain caused by chemotherapy-induced peripheral neuropathy (CIPN). CIPN occurs when chemotherapy drugs that kill cancer cells also damage nerves that send messages from the brain to the body, and causing nerves that send pain messages to become over- active. CIPN can cause a wide range of symptoms, often including tingling, pins and needles, and numbness and pain in the hands and feet. This is a Phase 2 trial of VMD-3866, which was effective in pre-clinical studies and was well-tolerated in Phase 1 healthy volunteer trials. VMD-3866 targets CIPN differently from existing treatments, by blocking certain proteins (called calcium channels) in the nerves under the skin and lowering their activity, therefore reducing pain. VMD-3866 is not an opiate or non-steroidal anti-inflammatory drug (NSAID) and is unlikely to be addictive or have any impact on your current medications.
This clinical trial will test repeated applications of VMD-3866 in participants with CIPN to find out if it reduces pain and if it has any side effects. Participants will have 2 study sessions, each of which will be 8 days long. In each session, eligible participants will visit the ward on the first and last days of their study sessions, and will have VMD-3866 gel or placebo gel (a dummy medicine that looks the same as the study medicine but has no active ingredient) applied to the skin on the feet/lower calves affected by CIPN. Participants will apply VMD-3866 or placebo gel at home once a day on the days between those visits.
Participants who consent may have up to 3 skin biopsies where a small sample of the skin will be taken from the lower leg. Participants will take about 7 weeks to finish the trial; they will make up to 6 outpatient visits and have a follow-up telephone call.
The trial will take place at Hammersmith Medicines Research Ltd (London). A pharmaceutical company, VM Therapeutics, is funding the trial. More details can be found on https://clinicaltrials.gov/study/NCT07072468.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