Clinical trial NCT05619328: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Sensory Neuropathy of Different Etiologies
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2022-11-16
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Neuropathy Total Symptom Score-6 (NTSS-6)
timeFrame: 120 days
Secondary outcomes:
measure: Quality of Life Questionnaire
timeFrame: 120 days
measure: modified Toronto Clinical Neuropathy Score (mTCNS) sensory test subscores
timeFrame: 120 days
measure: B vitamins blood levels
timeFrame: 120 days
measure: Safety Data
timeFrame: 120 days
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: RM Pharma Specialists S.A. de C.V.
Study officials:
References: