2022-500338-27-00招募中2 期
CAT-Trial: CGRP monoclonal Antibody for Treatment of painful diabetic neuropathy: a double-blind, multicenter, placebo-controlled, international phase II clinical trial
Aarhus University Hospital2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2023年2月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Difference in self-reported average pain intensity between eptinezumab treated group and placebo treated group by the average numerical rating scale (NRS) (0-10) using a modified version of the BPI from baseline (1 week before randomization) over 24 weeks after first administration.
研究概览
简要总结
To assess the efficacy of eptinezumab on pain intensity as measured as the change in weekly self-reported mean pain intensity (mean pain over the last 24 h recorded every morning in every fourth week in a diary) by the average numerical rating scale (NRS) (0-10) from baseline (1 week before randomization) over 24 weeks after first administration.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age 18 – 75 years
- •Confirmed diagnosis of probable diabetic polyneuropathy, as defined by the Toronto consensus criteria and a TCNS > 5 or abnormal DPNCheck or abnormal NCS
- •Probable neuropathic pain as defined by the NeuPSIG guidelines
- •Symmetric distal pain worse in the distal lower extremities present for >6 months
- •Average pain score on a NRS of ≥4 during the baseline week
排除标准
- •Prior or current use of a CGRP mAbs or CGRP antagonists
- •Planned larger surgery in the treatment period
- •Chronic wounds
- •Unable to understand Danish (Danish site only)
- •All female subjects of childbearing potential must have negative result of a serum pregnancy test performed at screening. Subjects of childbearing potential must agree to use a medically approved form of birth control (abstinence, intrauterine device (IUD), oral contraception, barrier and spermicide or hormonal implant) throughout the duration of the study.
- •Pregnant or planning to become pregnant during the duration of the study
- •Opioid regimen other than stable low dose of Tramadol (maximum 200 mg/day)
- •Lifetime history of psychosis, bipolar mania, or dementia. Patients with other psychiatric conditions whose symptoms are not controlled or who have not been adequately treated for a minimum of 6 months prior to screening are also excluded
- •Initiation of new neuropathic pain medications such as gabapentinoid medications (gabapentin, pregabalin) and/or capsaicin (Quetenza), botulinum toxin type A, serotonin/norepinephrine reuptake inhibitors (TCA or duloxetine or venlafaxine) 1 month prior to enrollment or for the duration of the randomized placebo-controlled phase of the study. Current and ongoing pain treatment will be allowed in stable dose (anticonvulsants, antidepressants, tramadol, topical treatments (excluding high dose capsaicin patch and botulinum toxin type A) (Paracetamol 1g and over-the-counter NSAIDS as needed up to four times daily are allowed as rescue medicine)
- •Suspected cause of lower extremity pain of other causes than diabetes (e.g. chemotherapy, alcohol or drug misuse, vitamin deficiency, concomitant central nervous system pathology) or patients with pain that cannot be distinguished from their neuropathic pain in the feet due to diabetes
- •The patient has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism)
- •BMI ≥39 kg/m2 at the screening visit
- •Peripheral arterial disease (PAD) defined as toe pressure <40mmHg, no palpable foot pulses or clinical claudicatio intermittens
结局指标
主要结局
Difference in self-reported average pain intensity between eptinezumab treated group and placebo treated group by the average numerical rating scale (NRS) (0-10) using a modified version of the BPI from baseline (1 week before randomization) over 24 weeks after first administration.
Difference in self-reported average pain intensity between eptinezumab treated group and placebo treated group by the average numerical rating scale (NRS) (0-10) using a modified version of the BPI from baseline (1 week before randomization) over 24 weeks after first administration.
次要结局
- Difference between groups in neuropathic pain severity as measured by Neuropathic Pain Scale (NPS) at baseline, weeks 12 and 24
- Difference in pain relief (complete, good, moderate, mild, none, worse) at weeks 12 and 24
研究者
Pall Karlsson
Scientific
Aarhus University Hospital
研究点 (2)
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