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), 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 blocking certain proteins (called calcium channels) in the nerves under the skin which will lower the activity of the nerves and therefore reduce pain. 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.
• 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).
• 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.