Actively Recruiting
Randomized, Double-blind, Placebo-controlled Crossover Study of Topical VMD-3866 Gel to Assess Pain Relief and Safety in Patients with Chemotherapy-induced Peripheral Neuropathy
Led by VM Therapeutics LLC · Updated on 2026-03-27
16
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating VMD-3866 gel, a new non-opioid, non-NSAID topical medicine, for treating pain caused by chemotherapy-induced peripheral neuropathy (CIPN). CIPN is nerve damage from certain chemotherapy drugs that causes pain and hypersensitivity. The study aims to see if this gel reduces pain symptoms and to identify any side effects. It works by blocking specific nerve proteins under the skin, reducing nerve activity and pain, with low risk of addiction or interaction with other medicines. This Phase 2a, double-blind, randomized crossover trial involves up to 16 participants who will each receive both the VMD-3866 gel and a placebo gel in two treatment periods separated by a washout of at least 7 days. Before each treatment period, there is a 7-day run-in where participants record pain scores daily. Participants will apply the gel themselves daily, visiting the study site for their first and last doses of each period while self-administering other doses at home. Some participants will have skin biopsies and quantitative sensory testing to assess nerve sensitivity. During the trial, participants will record daily pain scores in a diary and undergo assessments such as pain questionnaires, sleep interference measures, and global impression of change. Safety will be monitored through adverse event reports and skin evaluations. Follow-up calls will occur 7 to 14 days after the last dose or biopsy. The study will measure changes in pain scores and other outcomes to evaluate the gel's effect, with total participation lasting up to about one month.
CONDITIONS
Brief 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 chemotherapy for cancer and are in remission
- Diagnosed with chemotherapy-induced peripheral neuropathy (CIPN) with moderate symptoms for at least 3 months
- Stable CIPN symptoms for at least 8 weeks before screening
- Aged 18 to 80 years at consent
- Mean daily pain score of 4 to 8 on the Numeric Pain Rating Scale for at least 4 days during initial run-in
- ECOG Performance Status score of 0 or 1
- Able to self-apply topical gel to the affected area(s)
- Able to understand the trial and communicate with investigators
- Agree to use only allowed rescue medication (paracetamol) for breakthrough pain during the study
- Provide written informed consent
- Agree to contraception requirements
- Agree not to donate blood or blood products during and for 3 months after the trial
You will not qualify if you...
- Pregnant or lactating women, or premenopausal women not using reliable contraception
- History of painful conditions not related to CIPN requiring paracetamol or NSAIDs more than twice per week
- Peripheral neuropathy from other causes (e.g., alcohol, diabetes, toxins, hereditary, autoimmune)
- Abnormal medical history, physical exam, ECG, or lab values that could affect safety or study objectives
- Significant conditions like diabetes, seizures, or psychological disorders interfering with study
- Cardiovascular events within last 3 months
- Severe psychiatric or neuropsychiatric disorders, including recent suicide attempts or ideation
- Active or recent severe infections
- Damaged, tattooed, infected, or compromised skin at treatment area
- History of severe drug reactions or sensitivity to study gel ingredients
- Recent participation in skin irritation studies
- Contraindications to skin biopsy if biopsy required
- Recent participation in other clinical trials
- Use of topical capsaicin within 3 months before screening
- Use of opiates within 28 days before screening
- Use of non-approved pain medications within 14 days before run-in until last visit
- Scheduled radiation or chemotherapy during trial
- Blood pressure or pulse outside specified ranges at screening
- Prolonged QT interval on ECG
- Positive tests for hepatitis B, C, or HIV
- History of substance abuse, heavy alcohol use, smoking, or drug abuse
- Incomplete pain diary records during run-in
- Medical objections from general practitioner
- Unlikely to comply with trial requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 45 days before first treatment period
Participants are screened for eligibility to participate in the trial.
Outpatient visit up to 14 days before first dose for baseline assessments
Duration - 7 days before each treatment period
Participants record daily pain scores each morning in a trial diary to establish baseline symptoms before each treatment period.
Self-administered at home
Duration - 8 days per treatment period with at least 7 days washout between periods
Participants receive two treatment periods of topical gel (VMD-3866 or placebo) with a washout period in between; they self-administer most doses at home and visit the site for the first and last doses of each period.
2 visits per treatment period (first and last dose), other doses self-administered at home
Duration - 7 to 14 days after last treatment period
Participants are followed up by telephone call 7 to 14 days after the last topical dose or last skin biopsy, whichever is later.
1 telephone call
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
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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