Ibudilast in the Treatment of Medication Overuse Headache: A Double-blind, Randomised, Placebo-controlled Pilot Study
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Headache Index
研究概览
简要总结
The purpose of this study is to determine if ibudilast is effective in reverting patients with medication overuse headache suffering chronic daily headache back to their original episodic headache pattern.
详细描述
It has been established that excessive intake of medications used to treat primary headaches, particularly those containing opioids, can induce a form of secondary headache, known as medication overuse headache (MOH). Despite the significant clinical impact of this condition the mechanisms behind MOH remain poorly understood, guidelines for treatment are lacking, and relapse is common.
Recently, it has been recognised that repeated opioid exposure can facilitate pain by activating glia, the immunocompetent cells of the central nervous system, resulting in opioid-induced hyperalgesia (OIH).
The investigators hypothesise that MOH represents a form of OIH in this susceptible patient group - repeated activation of nociceptive pathways by frequent headaches interacts with the opioid induced pro-inflammatory actions of activated glia to produce chronic daily headache (CDH).
This double-blind, randomised, placebo controlled pilot study will investigate the use of ibudilast, a know attenuator of glial activation, in the treatment of medication overuse headache.
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ibudilast
To receive ibudilast 40mg twice daily for 8 weeks.
干预措施: Ibudilast (Drug)
Placebo
To receive placebo twice daily for 8 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Headache Index
时间窗: 2, 4, 8, 24 weeks
Headache Index as calculated by the summation of headache duration (hours) X headache intensity (11-point numerical rating scale), over the final two weeks of treatment.
次要结局
- Headache related impact on quality of life(2, 4, 8, 24 weeks)
- Allodynia symptom checklist score(2, 4, 8, 24 weeks)
- Medication frequency(2, 4, 8, 24 weeks)
- Headache frequency(2, 4, 8, 24 weeks)
- Duration of headache(2, 4, 8, 24 weeks)
- Intensity of headache(2, 4, 8, 24 weeks)
- Frequency of probable migraine attacks(2, 4, 8, 24 weeks)
- Von Frey filament test(2, 4, 8, 24 weeks)
- Brush allodynia test(2, 4, 8, 24 weeks)
- Response rate(2, 4, 8, 24 weeks)
- Relapse rate(2, 4, 8, 24 weeks)
研究者
Prof Paul Rolan
Professor Paul Rolan
University of Adelaide