Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorVM Therapeutics LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female patient who has received any type of chemotherapy treatment for cancer and are in remission.
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
VMD-3866 Gel
DrugEach 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 Gel
DrugEach 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.
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: VMD-3866 GelExperimental treatment 1 intervention
Group B: Placebo GelPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Daily for 8 days for each of 2 treatment periods, up to 1 month in total2
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.
Time frame
Daily for 8 days for each of 2 treatment periods, up to 1 month in totalSecondary outcomes
1
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.
Time frame
Daily for 8 days for each of 2 treatment periods, up to 1 month in total2
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.
Time frame
Day 1 and Day 8 for each of 2 treatment periods, up to 1 month in total3
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.
Time frame
Day 1 and Day 8 for each of 2 treatment periods, up to 1 month in total4
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).
Time frame
Day 8 for each of 2 treatment periods, up to 1 month in totalSponsors and contacts
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Source ClinicalTrials.gov