A Prospective Clinical Trial to Evaluate the Efficacy and... | NCT05619328

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 6, 2022Actual

Primary Completion Date

Nov 2, 2023Actual

Completion Date

Nov 2, 2023Actual

First Submitted Date

Nov 7, 2022

First Submission Date that Met QC Criteria

Nov 15, 2022

First Posted Date

Nov 16, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2023

Last Update Posted Date

Nov 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

323Actual

Label	Type	Description	Intervention Names
Vitamin B combination tablet (B1, B6, B12)	Experimental		Drug: Vitamin B combination tablet
Placebo tablet	Placebo Comparator		Drug: Placebo Tablet

Name	Type	Description	Arm Group Labels	Other Names
Vitamin B combination tablet	Drug	Once daily, with some liquid with or after a meal	Vitamin B combination tablet (B1, B6, B12)

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided