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

NCT05619328 | Completed Phase 3

• 1 other identifier: CSD2020153
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Sensory Neuropathy of Different Etiologies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Quality of Life Questionnaire

  120 days

• modified Toronto Clinical Neuropathy Score (mTCNS) sensory test subscores

  120 days

• B vitamins blood levels

  120 days

• Safety Data

  120 days

Study Arms (2)

Vitamin B combination tablet (B1, B6, B12)

EXPERIMENTAL

Drug: Vitamin B combination tablet

Placebo tablet

PLACEBO COMPARATOR

Drug: Placebo Tablet

Interventions

Vitamin B combination tablet DRUG

Once daily, with some liquid with or after a meal

Vitamin B combination tablet (B1, B6, B12)

Placebo Tablet DRUG

Once daily, with some liquid with or after a meal

Placebo tablet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand the purpose and risks of the study
• Considered reliable and capable of adhering to protocol, visit schedule, and medication administration instructions
• Demonstrates that participant can successfully complete the study eDiary using electronic device
• Male 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 symptoms
• Duration of peripheral sensory polyneuropathy symptoms ≥6 months
• Blood pressure ≤140/90 mmHg at Screening or taking a stable dose of antihypertensive medication
• Diabetes: diagnosed T1DM or T2DM ≥ 1 year prior Screening, HbA1c \<9% at Screening, no severe hyper-/hypoglycemia/ketoacidosis
• Stable on allowed concomitant medication
• Contraception for women of childbearing potential and men with potentially fertile female partner

You may not qualify if:

• Subjects with genetic, autoimmune, inflammatory and chemotherapy-induced peripheral neuropathy (PN), compressive mononeuropathy of lower extremity
• Subacute onset of peripheral sensory polyneuropathy
• No increase in PN symptoms for 1 y or longer
• Pain in the rest of the body higher than pain in the lower limbs from peripheral sensory polyneuropathy
• Fails to successfully submit eDiary data
• Known hypersensitivity to vitamins B1, B6, or B12
• Taken vitamin supplement containing vitamins B1, B6, B12, E, D higher than RDA
• Taken alpha lipoic acid
• Taken any cytostatic drug
• Taken anti-epileptics, opioids or other drugs for neuropathic pain management.
• Use of cannabis/cannabidiol
• Taken topical medication that alters sensation of assessment
• Subjects with any active systemic infection or disease that requires antibiotics, antifungals, antiviral agents
• BMI ≥35 kg/m2
• Pregnancy, subjects planning to become pregnant, or breastfeeding subjects

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

RM Pharma Specialists S.A. de C.V.

Mexico City, 03100, Mexico

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 16, 2022
• Study Start: September 6, 2022
• Primary Completion: November 2, 2023
• Study Completion: November 2, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

ME (1)