Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)
RecruitingPhase 2NCT07072468
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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)
- Conditions
- Chemotherapy-induced Peripheral Neuropathy
- Drug-Induced Nephropathy
- Interventions
- Drug: VMD-3866 Gel
- Drug: Placebo Gel
- Sponsor
- VM Therapeutics LLC
- Start date
- 2025-12-12
- Primary completion
- 2027-06-30
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- United Kingdom
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. 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. 2. Aged 18-80 years (inclusive) at the time of consent. 3. Mean daily pain score of 4-8 on the 11-point NPRS, for at least 4 days during Run-in 1. 4. A score of 0 or 1 on the ECOG Performance Status Scale. 5. Capable of self-administering topical VMD-3866 or placebo gel to the designated treatment area(s). 6. 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. 7. Agrees to take only the allowed rescue medication (paracetamol) for breakthrough pain, from screening and throughout the study. 8. 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. 9. Agrees to follow the contraception requirements of the trial. 10. Agrees not to donate blood or blood products during the trial and for up to 3 months after the administration of the trial medication. Exclusion Criteria: 1. Woman who is pregnant or lactating, or premenopausal woman who is sexually active and not using a reliable method of contraception. 2. 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. 3. Presence of peripheral neuropathy of another etiology (e.g. alcohol, diabetes, toxins, neurotoxic treatments, hereditary, autoimmune). 4. 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. 5. Clinical, history or previous laboratory evidence of significant condit…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07072468