Nummular Headache Iberian Study on the Treatments and Outcomes in Real-World Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- 50% response 8-12
研究概览
简要总结
The NUMITOR study is an analytical observational study with an multicenter ambisective (retrospective and prospective) cohort design.
详细描述
This study aims to create a multicenter registry that will increase the knowledge of nummular headache and assess which treatments are more effective and better tolerated. The study population will be patients with nummular headache who, under the opinion of their responsible neurologists, have required or require preventive treatment, in any of its modalities, oral or injectable.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Nummular headache according to the criteria of the International Classification of Headache Disorders, third version (ICHD-3).
- •Nummular headache duration of more than three months.
- •Treatment with a medication with possible preventive drug according to the Clinical Practice Guidelines of the Spanish Society of Neurology
- •Age over 18 years.
- •Informed consent signature.
排除标准
- •Diagnosis is better accounted for by any other entity included in the International Classification of Headache Disorders, 3rd version.
- •Serious systemic or psychiatric pathology that makes it difficult to assess the patient.
- •Secondary nummular headache
- •Use of preventive treatment with another indication (e.g., epilepsy, other painful conditions, aesthetic).
研究组 & 干预措施
Nummular headache patients
Patients that fulfill the International Classification of Headache Disorders, 3rd edition, for Nummular Headache.
干预措施: Clinical evaluation (Drug)
结局指标
主要结局
50% response 8-12
时间窗: Weeks 8-12
To evaluate the 50% responder rate in patients with NH treated with each preventive drug between weeks 8-12, compared to the baseline situation (month prior to the treatment onset) for each different drug.
次要结局
- 50% response 20-24(Weeks 20-24)
- 30% response 8-12(Weeks 8-12)
- 75% response 8-12(Weeks 8-12)
- 75% response 20-24(Weeks 20-24)
- Adverse events in patients older than 80(Weeks 0-24)
- 30% response 20-24(Weeks 20-24)
- Adverse events(Weeks 0-24)
- Response predictors weeks 8-12(Weeks 0-12)
- Adverse events in women(Weeks 0-24)
- 50% response 8-12 in patients older than 65(Weeks 0-12)
- Adverse events discontinuation(Weeks 0-24)
- 50% response 8-12 in women(Weeks 0-12)
- Adverse events in patients older than 65(Weeks 0-24)
- 50% response 8-12 in patients older than 80(Weeks 0-12)
研究者
David García Azorín
Principal Investigator, Headache Unit, Department of Neurology
Hospital Clínico Universitario de Valladolid