A Prospective Clinical Trial to Evaluate the Efficacy and Safety of Neurotropic B-Vitamins in Clinically Diagnosed Peripheral Sensory Polyneuropathy of Different Etiologies.

This study is designed to investigate the efficacy of the Test Product in subjects with clinically diagnosed peripheral sensory polyneuropathy of different etiologies compared to placebo.

Inclusion Criteria:Able to understand the purpose and risks of the studyConsidered reliable and capable of adhering to protocol, visit schedule, and medication administration instructionsDemonstrates that participant can successfully complete the study eDiary using electronic deviceMale or female, 18 to 70 years of age (inclusive)Subjects with symptoms of peripheral sensory polyneuropathy (measured with MNSI scale)NTSS-6 total score at Screening and Baseline: no severe symptomsDuration of peripheral sensory polyneuropathy symptoms ≥6 monthsBlood pressure ≤140/90 mmHg at Screening or taking a stable dose of antihypertensive medicationDiabetes: diagnosed T1DM or T2DM ≥ 1 year prior Screening, HbA1c <9% at Screening, no severe hyper-/hypoglycemia/ketoacidosisStable on allowed concomitant medicationContraception for women of childbearing potential and men with potentially fertile female partnerExclusion Criteria:Subjects with genetic, autoimmune, inflammatory and chemotherapy-induced peripheral neuropathy (PN), compressive mononeuropathy of lower extremitySubacute onset of peripheral sensory polyneuropathyNo increase in PN symptoms for 1 y or longerPain in the rest of the body higher than pain in the lower limbs from peripheral sensory polyneuropathyFails to successfully submit eDiary dataKnown hypersensitivity to vitamins B1, B6, or B12Taken vitamin supplement containing vitamins B1, B6, B12, E, D higher than RDATaken alpha lipoic acidTaken any cytostatic drugTaken anti-epileptics, opioids or other drugs for neuropathic pain management.Use of cannabis/cannabidiolTaken topical medication that alters sensation of assessmentSubjects with any active systemic infection or disease that requires antibiotics, antifungals, antiviral agentsBMI ≥35 kg/m2Pregnancy, subjects planning to become pregnant, or breastfeeding subjects