Back to resultsA Prospective Clinical Trial to Evaluate the Efficacy and Safety of Neurotropic B-Vitamins in Clinically Diagnosed Peripheral Sensory Polyneuropathy of Different Etiologies.
Primary Purpose
Peripheral Sensory Neuropathy of Different Etiologies
Status
Recruiting
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Vitamin B combination tablet
Placebo Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Sensory Neuropathy of Different Etiologies
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- RM Pharma Specialists S.A. de C.V.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin B combination tablet (B1, B6, B12)
Placebo tablet
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Quality of Life Questionnaire
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
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
Assess the effect of the Test Product on concentrations of vitamins B1, B6, and B12
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05619328
Brief Title
A Prospective Clinical Trial to Evaluate the Efficacy and Safety of Neurotropic B-Vitamins in Clinically Diagnosed Peripheral Sensory Polyneuropathy of Different Etiologies.
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Procter and Gamble
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Sensory Neuropathy of Different Etiologies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
318 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin B combination tablet (B1, B6, B12)
Arm Type
Experimental
Arm Title
Placebo tablet
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Vitamin B combination tablet
Intervention Description
Once daily, with some liquid with or after a meal
Intervention Type
Drug
Intervention Name(s)
Placebo Tablet
Intervention Description
Once daily, with some liquid with or after a meal
Primary Outcome Measure Information:
Title
Neuropathy Total Symptom Score-6 (NTSS-6)
Description
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.
Time Frame
120 days
Secondary Outcome Measure Information:
Title
Quality of Life Questionnaire
Description
The Quality of Life Questionnaire is a reliable, and valid measure of physical and mental health.
Time Frame
120 days
Title
modified Toronto Clinical Neuropathy Score (mTCNS) sensory test subscores
Description
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.
Time Frame
120 days
Title
B vitamins blood levels
Description
Assess the effect of the Test Product on concentrations of vitamins B1, B6, and B12
Time Frame
120 days
Title
Safety Data
Description
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
Time Frame
120 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Manager, PhD
Phone
+49 (0) 6196 8901
Email
trutz.o@pg.com
Facility Information:
Facility Name
RM Pharma Specialists S.A. de C.V.
City
Mexico City
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Manager, PhD
12. IPD Sharing Statement
Learn more about this trial
A Prospective Clinical Trial to Evaluate the Efficacy and Safety of Neurotropic B-Vitamins in Clinically Diagnosed Peripheral Sensory Polyneuropathy of Different Etiologies.
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