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)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 323
- 试验地点
- 1
- 主要终点
- Neuropathy Total Symptom Score-6 (NTSS-6)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Vitamin B combination tablet (B1, B6, B12)
干预措施: Vitamin B combination tablet (Drug)
Placebo tablet
干预措施: Placebo Tablet (Drug)
结局指标
主要结局
Neuropathy Total Symptom Score-6 (NTSS-6)
时间窗: 120 days
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.
次要结局
- Quality of Life Questionnaire(120 days)
- modified Toronto Clinical Neuropathy Score (mTCNS) sensory test subscores(120 days)
- B vitamins blood levels(120 days)
- Safety Data(120 days)