Peripheral Sensory Neuropathy of Different Etiologies
Conditions
Brief summary
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.
Detailed description
This prospective, multi-center, randomized, double-blind, placebo-controlled, parallel-group Phase III clinical study is designed to investigate the efficacy and safety of the Test product versus placebo in male and non-pregnant female subjects with clinically diagnosed peripheral sensory polyneuropathy of different etiologies aged 18 to 70 years. The study will be conducted in 17 sites in Mexico. 318 patients with clinically diagnosed symptoms of peripheral sensory polyneuropathy of different etiologies who fulfill the inclusion and exclusion criteria will be enrolled and randomized in a 1:1 ratio to receive either oral vitamin B combination daily or matching placebo for 120 days. The primary and secondary outcome measures will be evaluated at each post-Screening visit. Exploratory outcomes, and safety/tolerability/treatment satisfaction assessments will be evaluated as per schedule of activities. Approvals were obtained from Local Ethics Committees and from Mexican Regulatory Authority (COFEPRIS).
Interventions
DRUGVitamin B combination tablet
Once daily, with some liquid with or after a meal
DRUGPlacebo Tablet
Once daily, with some liquid with or after a meal
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Able to understand the purpose and risks of the study 2. Considered reliable and capable of adhering to protocol, visit schedule, and medication administration instructions 3. Demonstrates that participant can successfully complete the study eDiary using electronic device 4. Male or female, 18 to 70 years of age (inclusive) 5. Subjects with symptoms of peripheral sensory polyneuropathy (measured with MNSI scale) 6. NTSS-6 total score at Screening and Baseline: no severe symptoms 7. Duration of peripheral sensory polyneuropathy symptoms ≥6 months 8. Blood pressure ≤140/90 mmHg at Screening or taking a stable dose of antihypertensive medication 9. Diabetes: diagnosed T1DM or T2DM ≥ 1 year prior Screening, HbA1c \<9% at Screening, no severe hyper-/hypoglycemia/ketoacidosis 10. Stable on allowed concomitant medication 11. Contraception for women of childbearing potential and men with potentially fertile female partner
Exclusion criteria
1. Subjects with genetic, autoimmune, inflammatory and chemotherapy-induced peripheral neuropathy (PN), compressive mononeuropathy of lower extremity 2. Subacute onset of peripheral sensory polyneuropathy 3. No increase in PN symptoms for 1 y or longer 4. Pain in the rest of the body higher than pain in the lower limbs from peripheral sensory polyneuropathy 5. Fails to successfully submit eDiary data 6. Known hypersensitivity to vitamins B1, B6, or B12 7. Taken vitamin supplement containing vitamins B1, B6, B12, E, D higher than RDA 8. Taken alpha lipoic acid 9. Taken any cytostatic drug 10. Taken anti-epileptics, opioids or other drugs for neuropathic pain management. 11. Use of cannabis/cannabidiol 12. Taken topical medication that alters sensation of assessment 13. Subjects with any active systemic infection or disease that requires antibiotics, antifungals, antiviral agents 14. BMI ≥35 kg/m2 15. Pregnancy, subjects planning to become pregnant, or breastfeeding subjects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuropathy Total Symptom Score-6 (NTSS-6) | 120 days | The NTSS-6 scale is a validated neuropathy symptoms scale which evaluates the frequency and intensity of 6 neuropathy sensory symptoms in feet and legs such as numbness, prickling sensation, burning/aching/lancinating pain and allodynia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Questionnaire | 120 days | The Quality of Life Questionnaire is a reliable, and valid measure of physical and mental health. |
| modified Toronto Clinical Neuropathy Score (mTCNS) sensory test subscores | 120 days | The mTCNS is a reliable clinical score with high validity for tracking mild to moderate distal symmetric polyneuropathy (DSP) and is sensitive to early DSP changes. |
| B vitamins blood levels | 120 days | Assess the effect of the Test Product on concentrations of vitamins B1, B6, and B12 |
| Safety Data | 120 days | Safety of Vitamin B combination tablet in patients with peripheral sensory polyneuropathy in the feet comparing the incidence of adverse and serious adverse events, and the incidence of clinically significant laboratory values to Placebo * Incidence of adverse events (AEs) and serious adverse events (SAEs) * Incidence of clinically significant laboratory values |
Countries
Mexico
Outcome results
None listed