At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- VMD-3866 Gel (drug), Placebo Gel (drug)
- How long the study runs
- Study runs about 24 months (dates as stated)
- About the drug or intervention
- VMD-3866 Gel — drug: Each participant will have 2 treatment periods, separated by a washout of at least 7 days. · Placebo Gel — drug: Each participant will have 2 treatment periods, separated by a washout of at least 7 days.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 80 Years
- Who
- All
- Number of participants
- 16
- Started
- 2025-12-12
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for chemotherapy-induced peripheral neuropathy
- • Phase2 - 16 participants
- • Peripheral neuropathy is a disorder caused by damage to the peripheral nerves
Who can take part?
- • Ages 18 Years to 80 Years
- • Diagnosed with chemotherapy-induced peripheral neuropathy
Where?
- • London - Hammersmith Medicines Research Ltd (24-503; Tel: 0800 783 8792; recruit@hmrlondon.com)
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
This is a Phase 2a double-blind, randomized, crossover repeated-dose trial of VMD-3866 topical gel in patients diagnosed with CIPN. Enrolment of up to 16 participants is planned. 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. At the end of each treatment period, participants will undergo QST assessment and a skin biopsy if they had one at baseline. They will have a follow-up via telephone call 7-14 days after their last topical dose, or 7-14 days after the last skin biopsy (whichever is later).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 80 Years
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ had stable symptoms of CIPN for 8 weeks
What the study is looking for
- ✓Male or female patient who has received any type of drug treatment treatment for cancer and are in remission.
- ✓Aged 18-80 years (inclusive) at the time of consent.
- ✓Mean daily pain score of 4-8 on the 11-point NPRS, for at least 4 days during Run-in 1.
- ✓A score of 0 or 1 on the ECOG Performance Status Scale.
- ✓Capable of self-administering topical VMD-3866 or placebo gel to the designated treatment area(s).
Who cannot take part
- ✗Woman who is pregnant or lactating, or premenopausal woman who is sexually active and not using a reliable method of...
- ✗History of painful conditions not associated with CIPN (e.g. frequent headache) that require administration of...
- ✗Presence of peripheral neuropathy of another etiology (e.g. alcohol, diabetes, toxins, neurotoxic treatments,...
- ✗Cardiovascular events (stroke, heart attack, lung embolism) in the last 3 months.
- ✗Significant psychiatric or neuropsychiatric disorders including but not limited to severe depression, dementia,...
See the full criteria
Where Is This Study? (1 UK site)
Hammersmith Medicines Research Ltd (24-503; Tel: 0800 783 8792; recruit@hmrlondon.com)
London NW10 7EW, United Kingdom
How to Get in Touch
Jay Wu, PhD
Sponsor contactCONTACT
recruit@hmrlondon.com
Sponsor contactCONTACT
