An Open-Label, 12-Month Study to Evaluate the Safety and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 482
- 试验地点
- 41
- 主要终点
- Percentage of Participants With Attacks With Sustained Freedom From Headache Pain 2-48 Hours (Modified Intent to Treat Population)
研究概览
简要总结
Study STS101-003 is a multi-center, multiple dose (PRN), open-label, 12-month study to evaluate the safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine.
详细描述
The ASCEND trial is a multi-center, multiple dose (PRN), open-label, 12-month study to evaluate the safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, 18-65 years of age at the time of Screening Visit
- •Subject has at least 1-year history of migraines (with or without aura), according to the
- •International Classification of Headache Disorder, 3rd Edition (ICHD3)
排除标准
- •Pregnant or breast-feeding women
- •Women of child-bearing potential not using or not willing to use highly effective contraception.
- •Diagnosis of headache conditions other than migraine with or without aura, including diagnosis of basilar or hemiplegic migraines or cluster headache.
- •History of coronary artery disease, coronary artery vasospasm (including Printz-metals' angina), clinically significant arrhythmia or, peripheral vascular disease, ischemic disease (e.g. Raynaud's syndrome, ischemic bowel syndrome, angina pectoris, myocardial infarction, or documented silent ischemia); percutaneous coronary intervention, or cardiac surgery.
- •History of cerebrovascular disease, including but not limited to stroke, transient ischemic attack, cerebral hemorrhage, subarachnoid hemorrhage.
- •Diagnosis of major depression with current symptoms, psychosis, alcohol abuse or dependence, drug abuse or dependence, major psychiatric conditions (e.g. schizophrenia, psychosis or Bipolar disorder), dementia. Other significant neurological or psychiatric disorders (including other pain syndromes or risk of suicide) that in the opinion of the investigator might interfere with study participation and assessments or subject safety.
- •Any clinically significant symptoms or conditions, including but not limited to central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions or history of such conditions that, in the opinion of the investigator might interfere with study assessments or safety of participant.
研究组 & 干预措施
STS101
STS101 (dihydroergotamine nasal powder)
干预措施: Dihydroergotamine (Drug)
结局指标
主要结局
Percentage of Participants With Attacks With Sustained Freedom From Headache Pain 2-48 Hours (Modified Intent to Treat Population)
时间窗: At Month 12 of Study Medication Dosing
The subject's rating was documented on a four-point scale from no pain (= 0), mild pain (= 1), moderate pain (= 2) to severe pain (= 3). Pain freedom means the pain went from moderate (2) or severe (3) to no pain (0).
Percentage of Participants With Attacks With Sustained Freedom From Most Bothersome Symptom 2-48 Hours (Modified Intent to Treat Population)
时间窗: At Month 12 of Study Drug Administration
Subjects were prompted to document the presence of 3 symptoms (photophobia, phonophobia, and nausea) immediately before study drug administration and during the treated migraine attack.
次要结局
未报告次要终点