Anti-CGRP Neutralizing Antibody for Modulation of Neurogenic Inflammation in Trigeminal and Glossopharyngeal Pain Associated With Small Fiber Neuropathy/Fibromyalgia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in Pain Score
研究概览
简要总结
The investigators will treat patients (targeting enrollment of n=20) who suffer from trigeminal or glossopharyngeal nerve pain in the context of painful small fiber neuropathy. The primary pain-related objective is reduction of pain and reduced use of rescue and other anti-pain medications. Another goal is to monitor and confirm the safety profile established in the migraine population, during previous Phase 3 trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old.
- •The patient must have an assigned diagnosis of non-neuralgic trigeminal nerve pain G50.1, with all its permutations listed in the ICD10 explicitly allowed. Co-morbid trigeminal neuralgia G50.0 and G
- •… related headache codes are allowed. As an alternative to trigeminal nerve pain G50.1, glossopharyngeal nerve pain will be another inclusion criterion, with a G52.1 diagnosis and explicit mentioning of pain mediated by or in the innervation territory of the glossopharyngeal nerve.
- •In addition, patients have to be diagnosed with a painful small fiber neuropathy. This diagnosis is based on a skin biopsy or biopsy of an innervated surface epithelium with nerve fiber density count. The required ICD10 diagnostic codes are G63.3, G60.8, G62.
- •Co-morbidity with a fibromyalgia-related disorder will be allowed, typically summarized under a diagnosis code of M79.7.
排除标准
- •Patients that have a history of allergy or allergy-like incompatibility with a biologic that contains a human or humanized monoclonal antibody will be excluded.
- •Female patients of child-bearing age who are or want to become pregnant will be excluded. In case such a patient intends to participate, then she has to commit to a pregnancy prevention regimen that is based on hormonal contraceptive or intra-uterine device.
研究组 & 干预措施
Open Label Galcanezumab
Participants will receive their 1st injectable dose during the Day 30 visit. Participants will then inject themselves at home on Day 60 and again on Day 90.
干预措施: Galcanezumab (Drug)
结局指标
主要结局
Change in Pain Score
时间窗: Baseline (day 0), 45, 60, 75, 90, 105, 135, and 180 days
Patient reported 0-10 analog pain scale, where 0 = no pain and 10 = worst pain imaginable. Reported as the change between timepoints.
Number of Participants With a Change in Use of Anti-pain Medication
时间窗: Baseline through Day 135
Patient reported; any use of anti-pain medication.
Total Number of Adverse Events by Severity
时间窗: Collected through Day 180
Recording all potential adverse events, based on lab results, patient side effects logs, patient vital sign measurement, and medical record review. Adverse events can be classified into five severity grades (1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death).
次要结局
- Change in Level of TNF-alpha as a Marker of Pain or Inflammation(Baseline, Day 180)
- Change in Level of IL-6 as a Marker of Pain or Inflammation(Baseline, Day 180)