Unraveling the Spectrum of Migraine Resistant to Treatments: Searching for Novel Biological PHEnotypes and theRApeutic Approaches (SPHERA Project)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Monthly migraine days (MMDs)
研究概览
简要总结
Primary working hypothesis is that NON-responders to mAbs bear a dysfunction of the endocannabidiome system (eCBome), as suggested by pre-clinical and clinical data by our group.
They will be identified as patients showing a reduction of monthly migraine days < 50% after three months of treatment.
The clinical, biochemical and neurofunctional impact of novel therapeutic approaches expected to interfere with eCBome will be evaluated in NON-responder patients
详细描述
Monoclonal antibodies directed against the calcitonin gene related peptide pathway (mAbs) have recently become available as the first targeted-therapy for migraine prevention. Despite their revolution in migraine therapy, clinical evidence demonstrated that nearly one-third of patients do not respond to mAbs. Even among Responders (namely those with a reduction in monthly migraine days - MMDs, of at least 50%), almost half still suffers from 8 residual MMDs or more.
There is therefore room for improvement, and understanding the pathophysiological mechanisms involved in these processes is mandatory to develop novel therapies and optimize treatment outcome.
Among several non-CGRP pathways, the eCBome may play a major role in migraine as it interacts with multiple pathways to modulate inflammation and pain.
Previous evidence showed that genes expression of eCBome system is altered in migraine patients.
Interestingly, it seems possible to normalize eCBome dysfunction in migraineurs, as demonstrated by the decrease of FAAH levels in chronic migraineurs with medication overuse who underwent a successful detoxification.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female patients aged 18 to 75 years
- •diagnosis of episodic migraine or chronic migraine according to ICHD-3 criteria
- •for episodic migraine: 8-14 monthly migraine days in the previous 3 months
- •diagnosis of resistant migraine, defined by having failed at least 3 classes of migraine preventatives and suffer from at least 8 debilitating monthly headache days for at least 3 consecutive months
- •patients naive to CGRP targeting treatments
排除标准
- •history of major psychiatric or other neurological conditions
- •diagnosis of other primary or secondary headache disorders (only sporadic tension-type headache is allowed if the patients can clearly differentiate between the 2 types of headaches)
- •clinically significant medical conditions
- •chronic pain conditions
- •alcohol and/or drug abuse
- •pregnancy or lactation
结局指标
主要结局
Monthly migraine days (MMDs)
时间窗: Baseline (V0), after three months of intervention (V1), after six months of intervention (V2)
MMDs during treatment with PEA or KD (continuous variable)
次要结局
- Monthly headache days (MHDs)(Baseline (V0), after three months of intervention (V1), after six months of intervention (V2))
- Percentage of patients with a 50% reduction in MMDs(Baseline (V0), after three months of intervention (V1), after six months of intervention (V2))
- Quality of life assessed by means of MSQ(Baseline (V0), after three months of intervention (V1), after six months of intervention (V2))
- Monthly days and doses of acute drug intake(Baseline (V0), after three months of intervention (V1), after six months of intervention (V2))
- Migraine related disability assessed by means of MIDAS(Baseline (V0), after three months of intervention (V1), after six months of intervention (V2))
- Headache impact assessed by means of HIT-6(Baseline (V0), after three months of intervention (V1), after six months of intervention (V2))