Chemotherapy-induced Peripheral NeuropathyPhase 2NCT07072468
Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)
A Phase 2 study testing VMD-3866 Gel in people with Chemotherapy-induced Peripheral Neuropathy and Chemotherapy-induced Neuropathic Pain, run by VM Therapeutics LLC at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy, Chemotherapy-induced Neuropathic Pain, CIPN - Chemotherapy-Induced Peripheral Neuropathy
- What is being tested?
- VMD-3866 Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Dec 2025to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient who has received any type of chemotherapy treatment for cancer and are in remission.
- Participants must be diagnosed with CIPN and must be showing moderate (Grade 2, as defined by the Common Terminology Criteria for Adverse Events) symptoms of peripheral sensory neuropathy, including pain and hypersensitivity, for ≥ 3 months. Participants must have had stable symptoms of CIPN for 8 weeks before screening. Participants with any other conditions associated with neuropathy, or conditions which might confound pain assessment (e.g. other severe pain or a skin condition in the area affected by neuropathy) will be excluded.
- 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).
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- Capable of understanding the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
- Agrees to take only the allowed rescue medication (paracetamol) for breakthrough pain, from screening and throughout the study.
- Willing to give written consent to participate after reading the informed consent form, and after having the opportunity to discuss the trial with the investigator or their delegate.
- Agrees to follow the contraception requirements of the trial.
- Agrees not to donate blood or blood products during the trial and for up to 3 months after the administration of the trial medication.
Who cannot join
- Woman who is pregnant or lactating, or premenopausal woman who is sexually active and not using a reliable method of contraception.
- History of painful conditions not associated with CIPN (e.g. frequent headache) that require administration of paracetamol or non-steroidal anti-inflammatory drugs, more than twice a week.
- Presence of peripheral neuropathy of another etiology (e.g. alcohol, diabetes, toxins, neurotoxic treatments, hereditary, autoimmune).
- Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the participant.
- Clinical, history or previous laboratory evidence of significant conditions (e.g. diabetes, seizure or psychological conditions) that could interfere with completion of study procedures and assessments or pose an additional risk to the participant.
- Cardiovascular events (stroke, heart attack, pulmonary embolism) in the last 3 months.
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- Significant psychiatric or neuropsychiatric disorders including but not limited to severe depression, dementia, bipolar disorder or schizophrenia spectrum disorder.
- History of suicide attempt, or suicidal ideation in the last 6 months.
- Presence of active and/or systemic infection, or history of severe infection during the 30 days prior to screening.
- Damaged or tattooed skin, active skin disease, infection, severe erythema, or any other compromise in integrity of skin at the designated treatment area(s), which could influence or interfere with the evaluation of the safety or efficacy of VMD-3866.
- Presence or history of severe adverse reaction(s) to any drug or a history of sensitivity to any excipients of VMD-3866.
- Participation in any studies for skin irritation or sensitization within the 30 days before first dose.
- If a skin biopsy is required: contraindications to skin biopsy (e.g. patients with significant bleeding tendencies or using anti-coagulants).
- Receipt of an investigational medicinal product (including prescription medicines and devices) as part of another clinical trial, in the 3 months before first dose or 5-half-lives (whichever is longer); or is in the follow-up period of another clinical trial at the time of screening for this trial.
- Use of topical capsaicin preparations (including Qutenza patch) in the 3 months before screening.
- Use of opiate medication within the 28 days before screening.
- Use of any pain medication (except the approved pain medications, see below), from 14 days before Run-in 1 to the last on-site study visit.
- Non-approved medications include; salicylates, NSAIDs, topical analgesic-containing gels or creams or patches, local treatment with anesthetics (such as lidocaine), steroids, or transcutaneous electric nerve stimulation.
- Approved medications include:
- medications for the treatment of CIPN; gabapentin, pregabalin, amitriptyline, duloxetine, or a combination of those. The same medication/combination and dose should be used from 14 days before Run-in 1, until the end of the trial.
- paracetamol can be used as a rescue medication for pain as required.
- local anesthetic can be used prior to skin biopsy
- Scheduled to undergo radiation therapy or cancer chemotherapy during the trial.
- Diagnostic/screening assessments
- Blood pressure and pulse rate in supine position at the screening examination outside the following ranges: blood pressure 90-160 mm Hg systolic, 40-100 mm Hg diastolic; pulse rate 40_100 beats/min. If the values are out of range, one repeat is permitted. Patients can be included if the repeat value is within range.
- QTcF > 450 msec (men) or > 470 msec (women) at Screening and pre-dose on Day 1. If the values are out of range, one repeat is permitted. Patients can be included if the repeat value is within range.
- Positive test for hepatitis B, hepatitis C or HIV.
- Other
- Presence or history of drug or alcohol abuse within the last 10 years, intake of > 14 units of alcohol weekly, smoking > 10 cigarettes daily, or heavy use of e-cigarettes (including vapes).
- Evidence of drug abuse on urine testing.
- Completion of <5 days in the 7-day Run-in 1 trial diary.
- Objection by GP, on medical grounds, to patient entering trial.
- Possibility that the patient will not cooperate with the requirements of the protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Hammersmith Medicines Research Ltd (24-503; Tel: 0800 783 8792; recruit@hmrlondon.com)
London, UK, NW10 7EW
www.hmrlondon.com, 0800 783 8792, recruit@hmrlondon.com
HMR, Cumberland Avenue London NW10 7EW, +44 20 8961 4130, rec@hmrlondon.com
About this study
Official title: 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)
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.
Read the detailed description
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).
- Conditions
- Chemotherapy-induced Peripheral Neuropathy, Chemotherapy-induced Neuropathic Pain, CIPN - Chemotherapy-Induced Peripheral Neuropathy, Peripheral Neuropathic Pain, Peripheral Nerve Injuries, Pain, Nerve
- Being tested
- VMD-3866 Gel, Placebo Gel
- Keywords
- Chemotherapy-Induced Peripheral Neuropathy, Chemotherapy-Induced Peripheral Neuropathic Pain, Neuropathic Pain, Chronic Pain, Neuropathy, Tingling, Numbness, Burning, Drug-Induced Neuropathy, CIPN, Cancer Pain, Pain, Dysesthesia, Painful Paresthesia, Nerve Injury
- Medical subject headings
- Peripheral Nerve Injuries, Neuralgia, Chronic Pain, Disease, Agnosia, Paresthesia, Hypesthesia, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VMD-3866 GelDrug
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.
Placebo GelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| VMD-3866 Gel | Experimental | Treatment Group Receives: Drug: VMD-3866 Gel |
| Placebo Gel | Placebo comparator | Placebo Group Receives: Drug: Placebo Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the sum of daily numeric pain rating scale (NPRS) score at the end of each treatment period.
The participants assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable.
Measured: Daily for 8 days for each of 2 treatment periods, up to 1 month in total
Number of participants with an Adverse Event (AE).
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with AE(s) in each period will be reported.
Measured: Daily for 8 days for each of 2 treatment periods, up to 1 month in total
Secondary outcomes (6)
Change from baseline in average daily NPRS score, and the proportion of participants with at least 30% and 50% reductions
The participants assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable.
Measured: Daily for 8 days for each of 2 treatment periods, up to 1 month in total
Change from baseline in the short-form McGill Pain Questionnaire 2 (SF-MPQ-2)
The Short-form McGill Pain Questionnaire 2 (SF-MPQ-2) is a revised and expanded version of the original SF-MPQ, used to assess pain intensity and quality. It includes 22 descriptors of pain, with 11 sensory, 4 affective, and 7 neuropathic descriptors, rated on an 11-point numerical scale.
Measured: Day 1 and Day 8 for each of 2 treatment periods, up to 1 month in total
Change from baseline in weekly sleep interference scores assessed with Pain and Sleep Questionnaire three-item index (PSQ-3)
The Pain and Sleep Questionnaire (PSQ-3) is a concise tool designed to evaluate the influence of pain on sleep quality. Each of the 3 items is scored individually on a 100 mm Visual Analog Scale (VAS), ranging from 0 (representing 'never') to 100 (indicating 'always'). The total score is obtained by summing up the scores of all three items, providing a comprehensive measure of the impact of pain on sleep quality. By quantifying the frequency of sleep disturbances attributed to pain, the PSQ-3 provides valuable insights into the intricate relationship between pain and sleep, crucial for assessing the holistic impact of myofascial low back pain on patients' well-being.
Measured: Day 1 and Day 8 for each of 2 treatment periods, up to 1 month in total
Patient global impression of change (PGIC)
The PGIC is a scale participants use to rate the level of change they have experienced following treatment. The PGIC is a 7-point scale from 1 (very much better) to 7 (very much worse).
Measured: Day 8 for each of 2 treatment periods, up to 1 month in total
Frequency of use and dose of rescue medication during treatment period
Number of days a participant used the rescue medication during the treatment period.
Measured: Daily for each of 2 treatment periods, up to 1 month in total
Reduction in cutaneous hypersensitivity as measured by the quantitative sensory test (QST)
QST is a non-invasive diagnostic method used to assess the level at which a subject reports sensing a physical stimulus (detection threshold) applied to the skin. It is measured using specific testing equipment and protocol, and the exact scoring can vary based on the specific equipment and protocol used. In general, lower thresholds (i.e., the patient detects the stimulus at lower intensities) may indicate heightened sensitivity, while higher thresholds may indicate reduced sensitivity. Changes in these thresholds over time can indicate a worsening of sensory dysfunction.
Measured: Baseline on Day 1, and postdose on Day 8 of each of 2 treatment periods, up to 1 month in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start12 Dec 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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 numeric pain rating scale (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). Eligible participants may attend an outpatient visit up to 14 days before their first dose of VMD-3866 or placebo, for baseline QST (quantitative sensory test) 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VM Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development, Study chair, VM Therapeutics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072468
- Sponsor's protocol ID
- VMT-03C
- Other IDs
- 119106, 1011031
- Status last verified
- Oct 2026
- First submitted
- 30 May 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07072468
- Acronym / sponsor ID
- VMT-03C
- Conditions
- Chemotherapy-induced Peripheral Neuropathy, Chemotherapy-induced Neuropathic Pain, CIPN - Chemotherapy-Induced Peripheral Neuropathy, Peripheral Neuropathic Pain, Peripheral Nerve Injuries, Pain, Nerve
- Keywords
- Chemotherapy-Induced Peripheral Neuropathy, Chemotherapy-Induced Peripheral Neuropathic Pain, Neuropathic Pain, Chronic Pain, Neuropathy, Tingling, Numbness, Burning
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- VM Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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 numeric pain rating scale (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). Eligible participants may attend an outpatient visit up to 14 days before their first dose of VMD-3866 or placebo, for baseline QST (quantitative sensory test) 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
| Arm | Type | Receives |
|---|---|---|
| VMD-3866 Gel | Experimental | Drug: VMD-3866 GelTreatment Group |
| Placebo Gel | Placebo comparator | Drug: Placebo GelPlacebo Group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patient who has received any type of chemotherapy treatment for cancer and are in remission.
- Participants must be diagnosed with CIPN and must be showing moderate (Grade 2, as defined by the Common Terminology Criteria for Adverse Events) symptoms of peripheral sensory neuropathy, including pain and hypersensitivity, for ≥ 3 months. Participants must have had stable symptoms of CIPN for 8 weeks before screening. Participants with any other conditions associated with neuropathy, or conditions which might confound pain assessment (e.g. other severe pain or a skin condition in the area affected by neuropathy) will be excluded.
- 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.
Key exclusion criteria (33 listed)
- Woman who is pregnant or lactating, or premenopausal woman who is sexually active and not using a reliable method of contraception.
- History of painful conditions not associated with CIPN (e.g. frequent headache) that require administration of paracetamol or non-steroidal anti-inflammatory drugs, more than twice a week.
- Presence of peripheral neuropathy of another etiology (e.g. alcohol, diabetes, toxins, neurotoxic treatments, hereditary, autoimmune).
- Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the participant.
- Clinical, history or previous laboratory evidence of significant conditions (e.g. diabetes, seizure or psychological conditions) that could interfere with completion of study procedures and assessments or pose an additional risk to the participant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VMD-3866 GelEach 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. | Drug | VMD-3866 Gel |
| Placebo GelEach 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. | Drug | Placebo Gel |
Primary outcome
Change from baseline in the sum of daily numeric pain rating scale (NPRS) score at the end of each treatment period.
Time frame: Daily for 8 days for each of 2 treatment periods, up to 1 month in total
The participants assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable.
Number of participants with an Adverse Event (AE).
Time frame: Daily for 8 days for each of 2 treatment periods, up to 1 month in total
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with AE(s) in each period will be reported.
6 secondary outcomes
Change from baseline in average daily NPRS score, and the proportion of participants with at least 30% and 50% reductions
Time frame: Daily for 8 days for each of 2 treatment periods, up to 1 month in total
Change from baseline in the short-form McGill Pain Questionnaire 2 (SF-MPQ-2)
Time frame: Day 1 and Day 8 for each of 2 treatment periods, up to 1 month in total
Change from baseline in weekly sleep interference scores assessed with Pain and Sleep Questionnaire three-item index (PSQ-3)
Time frame: Day 1 and Day 8 for each of 2 treatment periods, up to 1 month in total
Patient global impression of change (PGIC)
Time frame: Day 8 for each of 2 treatment periods, up to 1 month in total
Frequency of use and dose of rescue medication during treatment period
Time frame: Daily for each of 2 treatment periods, up to 1 month in total
Reduction in cutaneous hypersensitivity as measured by the quantitative sensory test (QST)
Time frame: Baseline on Day 1, and postdose on Day 8 of each of 2 treatment periods, up to 1 month in total
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- HMR code 24-503; Safety and effectiveness of VMD-3866 in patients with CIPN (Protocol number VMT-03C)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Development study chair
VM Therapeutics LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VMD-3866 Gel in people with Chemotherapy-induced Peripheral Neuropathy and Chemotherapy-induced Neuropathic Pain, run by VM Therapeutics LLC at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jay Wu, PhD (+1 510 962 8100 ext. 101, om@vmtherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the sum of daily numeric pain rating scale (NPRS) score at the end of each treatment period. (time frame: Daily for 8 days for each of 2 treatment periods, up to 1 month in total). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.