Efficacy and Safety of Pregabalin in Treatment of Neuropathic Pain in Patients With Idiopathic Small Fiber Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Visual Analogue Score for Pain Intensity.
研究概览
简要总结
The purpose of this study is to assess safety and efficacy of treatment with pregabalin in patients with idiopathic small fiber neuropathy proven by skin biopsy.This is an enriched enrollment randomized withdrawal study that comprises 4 phases: a screening and selection phase, a washout period from previous pain medication for enriched enrollment, an 8 week single blind pregabalin treatment phase; and a 4 week randomized withdrawal phase.
详细描述
Patients who show any increase in their pain intensity score during the washout phase will be eligible for the single blind pregabalin treatment phase. Patients who respond to pregabalin, with at least 1 point improvement in neuropathic pain from baseline at the end of the single blind pregabalin treatment phase and meeting all other study requirements are considered eligible for participation in the withdrawal phase. These eligible patients are randomly assigned (1:1) to continue pregabalin or to be switched to placebo for a comparison of pregabalin efficacy and safety. Patients who have a worsening of average pain relative to the last week of the single blind pregabalin treatment period by more than one point and average pain level > =4 will be considered to have a loss of therapeutic response (LTR).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with idiopathic predominate-small fiber neuropathy
- •Subject must have chronic peripheral neuropathic pain for more than 3 months
- •A score >3 and <8 on Pain intensity scale for pain in prior week at first visit;
- •Show increase in pain intensity scores during the wash off period;
- •Age older than 18 years;
排除标准
- •Subjects with large-fiber predominant neuropathy
- •Subjects with HIV infection, trigeminal neuralgia (TGN), toxic neuropathy (e.g. chemotherapy exposure), paraneoplastic neuropathy, mono-gammopathy, inflammatory neuropathy, celiac disease, systemic lupus, peripheral vascular disease, connective tissue disorders, hepatitis C, Fabry disease, and diabetes;
- •Subjects with uncontrolled thyroid or B12 disorders
- •Subjects with Complex Regional Pain Syndrome
- •Allergy to Pregabalin
- •Subjects at risk of suicide or self harm
- •Subjects with any clinically unstable cardiovascular, hematological, autoimmune, endocrine, renal, hepatic, renal, respiratory, or gastrointestinal disease; epilepsy, symptomatic peripheral vascular disease including intermittent claudication, pernicious anemia, untreated hypothyroidism, venous insufficiency, or spinal stenosis.
- •History of known analgesic, alcohol or illicit drug abuse within 12 months of first visit;
- •Pregnant females; breastfeeding females.
研究组 & 干预措施
Pregabalin Treatment phase
All patients will be initially treated with pregabalin in a single blind fashion
干预措施: Pregabalin (Drug)
Withdrawal phase
After finishing the treatment phase, some patients will be randomized to the placebo or continue on pregabalin for the 4 weeks of withdrawal phase.
干预措施: Placebo (Drug)
结局指标
主要结局
Visual Analogue Score for Pain Intensity.
时间窗: Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase
The primary outcome is change in visual analogue score for pain, with 0 being no pain at all and 10 being the most severe pain and a higher score meaning more pain, after 8 weeks of treatment phase and 4 weeks of randomized withdrawal phase.
次要结局
- Brief Pain Inventory (BPI sf);(Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase)
- Sleep Quality as Assessed by Daily Sleep Interference Rating Scale (SIRS);(Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase)
- Patient Global Impression of Change (PGIC);(At 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase)