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

A Prospective, Multicenter, Randomized, Double Blind, Placebo-controlled Parallel Group Clinical Trial to Evaluate the Efficacy and Safety of the Product Vitamins B1 (100mg), B6 (100 mg), Plus B12 (5 mg) in Tablets in Subjects With Clinically Diagnosed PerIpheral Sensory polyNeuropathy of Different etiologieS (PINS Study)

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Sensory Neuropathy of Different Etiologies
• Intervention / Treatment: Drug: Vitamin B combination tablet; Drug: Placebo Tablet

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).

• Study Type: Interventional
• Enrollment (Actual): 323
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Manager, PhD; Phone Number: +49 (0) 6196 8901; Email: trutz.o@pg.com

Study Locations

• Mexico
  • Mexico City, Mexico, 03100
    • RM Pharma Specialists S.A. de C.V.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo tablet	Drug: Placebo Tablet; Once daily, with some liquid with or after a meal
Experimental: Vitamin B combination tablet (B1, B6, B12)	Drug: Vitamin B combination tablet; Once daily, with some liquid with or after a meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropathy Total Symptom Score-6 (NTSS-6)	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.	120 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Questionnaire	The Quality of Life Questionnaire is a reliable, and valid measure of physical and mental health.	120 days
modified Toronto Clinical Neuropathy Score (mTCNS) sensory test subscores	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.	120 days
B vitamins blood levels	Assess the effect of the Test Product on concentrations of vitamins B1, B6, and B12	120 days
Safety Data	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	120 days

Collaborators and Investigators

• Sponsor: Procter and Gamble

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2022
• Primary Completion (Actual): November 2, 2023
• Study Completion (Actual): November 2, 2023

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 16, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyneuropathies; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex
• Other Study ID Numbers: CSD2020153

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No