NCT02392273终止不适用
A Prospective Observational Registry of Primary Headache Patients Treated With Ausanil
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (all cause)
研究概览
简要总结
This study is an observational study with the primary objective to assess the safety and tolerability of Ausanil in the treatment of primary headache disorders. The secondary objective is to assess headache pain, functional outcome, time loss to headache and patient satisfaction with Ausanil treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Men and women aged 18 to 80 years
- •Primary Headache disorder as per International Classification of Headache Disorders-11
- •Ausanil naive
- •Signed dated informed consent
- •Females of childbearing potential must be using adequate contraception during study period.
- •Willing and able to comply with registry requirements to document headache response
排除标准
- •Known allergy to Ausanil or any of its ingredients
- •Active bronchial asthma that in the opinion of the investigator would interfere with use of Ausanil
- •Nasal obstruction due to any cause or extensive nasal surgery resulting in scarring or other such impact on nasal mucosa that might lead to heightened sensitivity to Ausanil in the opinion of the investigator.
- •Pregnant or breast feeding females
- •History of addictive behavior
- •Any severe or chronic unstable medical or psychiatric condition
- •Active nasal infection or inflammation
- •Unable or unwilling to provide informed consent
- •Suffer from atypical, basilar or hemiplegic migraine that is new onset or unstable.
结局指标
主要结局
Incidence of Adverse Events (all cause)
时间窗: 8 weeks
Patient/Physician reporting
Incidence of Adverse Events causally related to Ausanil
时间窗: 8 weeks
Patient/Physician reporting
Serious Adverse Events
时间窗: 8 weeks
Patient/Physician reporting
次要结局
- Headache Response to Ausanil(24 hours)
- Functional Assessment(24 Hours)
- Patient satisfaction for Treatment(24 hours)
- Time Loss to headache(24 hours)
- Use of Rescue Medication(24 hours)
- Sting severity and duration(one hour)
研究者
研究点 (1)
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