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Tests treatment safety and results for Chemotherapy-induced Peripheral Neuropathy
Official title Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)
ClinicalTrials.gov ID: NCT07072468
What this study is testing
What is VMD-3866 Gel?
VMD-3866 Gel is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for chemotherapy-induced peripheral neuropathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Male or female patient who has received any type of chemotherapy treatment for cancer and are in remission. Participants must be diagnosed with CIPN...
- 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).
You likely can't join if
- 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...
- 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...
- Clinical, history or previous laboratory evidence of significant conditions (e.g. diabetes, seizure or psychological conditions) that could interfere...
- Cardiovascular events (stroke, heart attack, pulmonary embolism) in the last 3 months.
See the full eligibility criteria
Who can 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...
- 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).
- 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...
- 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.
What rules you out
- 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...
- Cardiovascular events (stroke, heart attack, pulmonary embolism) in the last 3 months.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- London, UK, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, UK, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.