Actively Recruiting
Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)
Led by VM Therapeutics LLC · Updated on 2026-03-27
16
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients who have received any chemotherapy treatment for cancer and are currently in remission
- Diagnosed with chemotherapy-induced peripheral neuropathy showing moderate (Grade 2) symptoms including pain and hypersensitivity for at least 3 months
- Stable CIPN symptoms for at least 8 weeks before screening
- Aged between 18 and 80 years at consent
- Mean daily pain score between 4 and 8 on the 11-point numeric pain rating scale for at least 4 days during the first run-in period
- ECOG Performance Status score of 0 or 1
- Able to self-apply the topical gel to the designated treatment area
- Able to understand the trial, communicate with investigators, and comply with trial requirements
- Agree to use only permitted rescue medication (paracetamol) during the study
- Willing to provide written informed consent
- Agree to follow contraception requirements during the trial
- Agree not to donate blood or blood products during the trial and for 3 months after trial medication
You will not qualify if you...
- Pregnant or lactating women, or sexually active premenopausal women not using reliable contraception
- History of painful conditions not related to CIPN that require frequent use of paracetamol or NSAIDs
- Peripheral neuropathy from other causes such as alcohol, diabetes, toxins, hereditary, or autoimmune
- Clinically significant abnormal medical history, physical exam, ECG, or lab results that could affect safety or trial objectives
- Significant conditions like diabetes, seizures, or psychological disorders that could interfere with study or pose risk
- Recent cardiovascular events (stroke, heart attack, pulmonary embolism) within the last 3 months
- Severe psychiatric or neuropsychiatric disorders, recent suicidal ideation or attempts
- Active or recent severe infection within 30 days before screening
- Damaged or compromised skin at the treatment area that could affect safety or evaluation
- History of severe allergic reactions to any drug or components of VMD-3866
- Participation in skin irritation or sensitization studies within 30 days before first dose
- Contraindications to skin biopsy if biopsy is required
- Use of investigational drugs or devices within 3 months or during follow-up of another trial
- Use of topical capsaicin products within 3 months before screening
- Use of opioid medication within 28 days before screening
- Use of prohibited pain medications from 14 days before run-in until last study visit
- Scheduled radiation therapy or chemotherapy during the trial
- Blood pressure or pulse outside specified ranges at screening after repeat test
- QTcF interval above specified limits at screening and pre-dose after repeat test
- Positive test for hepatitis B, hepatitis C, or HIV
- History of drug or alcohol abuse in last 10 years, excessive alcohol or tobacco use
- Positive urine drug screen
- Incomplete run-in diary data
- Medical objection from general practitioner
- Likely inability to comply with protocol requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hammersmith Medicines Research Ltd (HMR code 24-503)
London, UK, United Kingdom, NW10 7EW
Actively Recruiting
Research Team
J
Jay Wu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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