Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
NCT ID:
NCT05619328
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05619328
Study Brief:
Protocol Section:
NCT05619328