A Prospective Clinical Trial to Evaluate the Efficacy and Safety of Neurotropic B-Vitamins in Clinically Diagnosed Peripheral Sensory Polyneuropathy of Different Etiologies.
NCT ID: NCT05619328
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
323 participants
INTERVENTIONAL
2022-09-06
2023-11-02
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vitamin B combination tablet (B1, B6, B12)
Vitamin B combination tablet
Once daily, with some liquid with or after a meal
Placebo tablet
Placebo Tablet
Once daily, with some liquid with or after a meal
Interventions
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Vitamin B combination tablet
Once daily, with some liquid with or after a meal
Placebo Tablet
Once daily, with some liquid with or after a meal
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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Procter and Gamble
INDUSTRY
Responsible Party
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Locations
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RM Pharma Specialists S.A. de C.V.
Mexico City, , Mexico
Countries
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Other Identifiers
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CSD2020153
Identifier Type: -
Identifier Source: org_study_id