A double blind, placebo controlled, randomized crossover, pilot study of topical RM191A spray for the relief of neuropathic pain

INTERVENTION: Single dose, crossover study design whereby each participant receives Copper Amino Acid Chelate (RM191A) complex (10%) in the form of spray on one occasion and Placebo on the other occasion separated by three days washout period. The participant will be blinded and randomised and receive treatments in random order. Participants are anticipated to use either the active RM191A or Placebo spray over each of the recorded painful area four times a day at 8AM, 12PM, 4PM and 8PM with up to eight sprays per area for five consecutive days. Upon the completion of first five days of treatment, the participants will crossover to the other arm and start and repeat the other treatment as above for another five days after three days of washout period. Participants will be required to complete Participant Diary at approximately 8 PM every evening following the Screening Visit prior to their 8PM intervention. During each scheduled Clinic Follow Up Visit, these diaries will be monitored to ensure participant's adherence to the intervention as per the study protocol. Participants are required to attend four Clinic Follow Up Visits once they are enrolled into the study and will complete questionnaires on pain, laboratory testings to assess the health of the participants and be monitored for any abnormalities. The investigational product and the placebo comes in 150 mL bottle and each spray will be 0.2 mL in volume. CONDITION: Neuropathic Pain PRIMARY OUTCOME: Change in Patient‐Reported Neuropathic Pain Intensity as assessed by Numeric Pain Rating Scale (NPRS) SECONDARY OUTCOME: To assess the safety and tolerability of topical RM191A spray by careful monitoring of following safety parameters: 1. Skin irritation 2. Adverse events 3. Evaluation of any medically significant changes, based on neurological and physical examination findings 4. Clinical laboratory testing with abnormal results INCLUSION CRITERIA: 1, Male/female patient aged 18 years or older, with moderate to severe neuropathic pain present for at least 3 months. 2. Affected area is appropriate for topical treatment. 3. Skin is intact over the area to be treated. 4. Pain must be due to neuropathic pain that, in the opinion of the Investigator, is of an appropriate severity for treatment. 5. Patient must have appropriate NPRS "average pain over the last 24 hours" for at least 3 of the 7 days prior to the Baseline Visit. 6. Prior pain medications expected to be continued at current level for the duration of the study.