RecruitingPhase 2NCT07072468

Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)

A Randomized, Double-blind, Placebo-controlled Crossover Study to Evaluate Analgesic Efficacy, Safety and Tolerability of Repeated Doses of Topical VMD-3866 in Patients With Chemotherapy-induced Peripheral Neuropathy (CIPN)

Sponsor

VM Therapeutics LLC

Enrollment

16 participants

Start Date

Dec 12, 2025

Study Type

INTERVENTIONAL

Conditions

Chemotherapy Induced Peripheral Neuropathy Drug-Induced Nephropathy

Summary

Peripheral neuropathy is a disorder caused by damage to the peripheral nerves. Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of certain chemotherapy drugs, such as platinum-based compounds, taxanes, and vinca alkaloids, which can damage nerve fibres by disrupting their structure and function. At present, relief of neuropathic pain in CIPN is limited, and existing therapies providing only modest and variable efficacy across patients. This is a study of VMD-3866 gel (the study medicine which is non-opioid, non-NSAID), an experimental new topical medicine for treating pain caused by CIPN. The goal of this study is to assess if the study medicine improves pain symptoms in patients with CIPN, and to find out the side effects of the study medicine if any. The study medicine will work by selectively blocking a specific sub-type of proteins (called T-type calcium channels) in the nerves under the skin which will lower the activity of the nerves and therefore reduce pain. It is a topical gel, meaning that it is applied to the skin, and its novel gel formulation limits that only little amount of study medicine may enter the blood and none enters the brain. This means it's unlikely to be addictive and it's unlikely to have any impact on participant current medications. Researchers will compare study medicine to a matching placebo (a look-alike gel that contains no drug) to see if VMD-3866 gel works to management of pain caused by CIPN.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a topical gel (VMD-3866) applied to the skin to see if it can reduce nerve pain caused by chemotherapy — a condition called chemotherapy-induced peripheral neuropathy (CIPN). Many cancer survivors experience lasting tingling, numbness, and pain in their hands and feet after chemo, and this study looks for a topical treatment option. **You may be eligible if...** - You have completed chemotherapy for cancer and are in remission - You have moderate nerve pain (Grade 2 CIPN) in your hands or feet that has lasted at least 3 months - Your symptoms include pain and hypersensitivity **You may NOT be eligible if...** - You are currently receiving chemotherapy - Your nerve pain is mild (Grade 1) or severe (Grade 3+) - Your symptoms have lasted less than 3 months - You have other causes of nerve pain unrelated to chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVMD-3866 Gel

Each participant will have 2 treatment periods, separated by a washout of at least 7 days. Participants will be randomized 1:1 to receive VMD-3866 gel in one period, and placebo gel in the other. Before the start of each treatment period, participants will have a Run-in period lasting 7 days, during which they will record NPRS scores each morning in a trial diary. Participants will continue to record NPRS scores in the trial diary during treatment periods 1 and 2 (about 1 h after each dose). Participants will be screened within 45 days before their first treatment period. Eligible participants may attend an outpatient visit up to 14 days before their first dose of VMD-3866 or placebo, for baseline QST and, in ≥ 8 participants, a skin biopsy. Participants will visit the site for their first and last doses (Days 1 and 8) in each treatment period. All other doses they will self-administer at home.

DRUGPlacebo Gel