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

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Procter and Gamble
• Treatments: Vitamin B Complex; Vitamins

Criteria

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