A Randomized, Double-blind, Placebo-controlled, Crossover, Multi-center Clinical Trial for the Evaluation of Efficacy, Safety, and Tolerability of ASY202 for the Acute Treatment of Migraine in Adult Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 6
- 主要终点
- Proportion of patients with freedom from headache pain at 2 hours post-dose
研究概览
简要总结
This study is testing an investigational inhaled migraine medication to see how well it works, how safe it is, and how well people tolerate it. Adults with migraine will receive both the study medication (ASY202) and a placebo (inactive treatment) at different times during the study. Neither participants nor study staff will know which treatment is given at the time. The medication is taken using a handheld dry powder inhaler to treat migraine attacks when they occur.
Following screening, eligible participants will be enrolled and randomized to one of two treatments sequences i.e. one treatment sequence will receive ASY202 in treatment period 1 followed by placebo in treatment period 2 and other treatment sequence will receive placebo in treatment period 1 followed by ASY202 in treatment period 2.
The study lasts about 16 weeks and includes a screening period, two treatment periods (with a minimum of 7 days washout period between the treatment periods), and a safety follow-up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Sponsor, contract research organization (CRO), participants, investigators, and study personnel involved in clinical assessments will remain blinded to treatment assignment throughout the study. ASY202 and placebo will be identical in appearance, packaging, labelling, and administration to ensure blinding is maintained.
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
- •Able to understand study procedures and provide written informed consent
- •Male or female, 18-65 years of age at Screening
- •BMI between 18.5-35 kg/m² at Screening
- •Documented history of migraine (with or without aura) for ≥1 year, consistent with the International Classification of Headache Disorders, 3rd Edition (ICHD-3)
- •Female participants must be either:
- •of non-childbearing potential, or
- •of childbearing potential using protocol required contraception
排除标准
- •Diagnosis of headache conditions other than migraine
- •History or current diagnosis of coronary artery disease (CAD)
- •History or current diagnosis of coronary artery vasospasm (including Printz-metal's angina), clinically significant arrhythmia (e.g., ventricular tachycardia, ventricular fibrillation) or peripheral vascular disease, ischemic disease (e.g., Raynaud's syndrome, ischemic bowel syndrome, angina pectoris, myocardial infarction, or documented silent ischemia)
- •History of percutaneous coronary intervention, cardiac surgery, sepsis or vascular surgery
- •History or current diagnosis of cerebrovascular disease, including but not limited to stroke, transient ischemic attack, cerebral hemorrhage, or subarachnoid hemorrhage
- •Known history or current diagnosis of psychological and/or psychiatric condition that, in the opinion of the Investigator, might interfere with study participation and assessments or participant safety. These conditions may include depression, psychosis, schizophrenia, bipolar disorder, dementia, alcoholism, drug abuse, etc.
- •Known allergic reactions, hypersensitivity, or contraindications to DHE, other ergot-derived products, or any other excipient in the formulation
- •Use of strong or moderate CYP3A4 inhibitors within 14 days (or 5 half-lives) or CYP3A4 inducers within 28 days (or 5 half-lives) prior to Randomization
- •Any clinically significant symptoms or conditions at screening, other than migraine, 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 participant safety
研究组 & 干预措施
ASY202, Then Placebo
ASY202 is a pre-metered drug-device combination product containing DHE dry powder formulation for oral inhalation, delivered via a dry powder inhaler (DPI) device. In Treatment Period 1, participants will receive ASY202, followed by a washout period and subsequent administration of placebo in Treatment Period 2. The placebo consists of an inactive inhalation powder delivered via a matching DPI device.
干预措施: ASY202 (Combination Product)
Placebo, Then ASY202
In Treatment Period 1, participants will receive placebo inhalation powder delivered via a dry powder inhaler (DPI) device, followed by a washout period and subsequent administration of ASY202 in Treatment Period 2.
干预措施: Placebo (Combination Product)
ASY202, Then Placebo
ASY202 is a pre-metered drug-device combination product containing DHE dry powder formulation for oral inhalation, delivered via a dry powder inhaler (DPI) device. In Treatment Period 1, participants will receive ASY202, followed by a washout period and subsequent administration of placebo in Treatment Period 2. The placebo consists of an inactive inhalation powder delivered via a matching DPI device.
干预措施: Placebo (Combination Product)
Placebo, Then ASY202
In Treatment Period 1, participants will receive placebo inhalation powder delivered via a dry powder inhaler (DPI) device, followed by a washout period and subsequent administration of ASY202 in Treatment Period 2.
干预措施: ASY202 (Combination Product)
结局指标
主要结局
Proportion of patients with freedom from headache pain at 2 hours post-dose
时间窗: 2 hours Post-Dose
Proportion of patients achieving freedom from headache pain at 2 hours following administration of a single 2.0 mg dose of ASY202 compared with placebo. Headache pain freedom is defined as a reduction from moderate or severe headache intensity (score of 2 or 3 on a 4-point scale) at baseline (time 0) to no headache pain (score of 0 on the same 4-point scale) at 2 hours post-dose.
次要结局
- Proportion of patients with freedom from the most bothersome symptom (MBS) at 2 hours post-dose.(2 hours Post-Dose)
- Proportion of patients with relief from headache pain at 2 hours post-dose(2 hours Post-Dose)
- Proportion of patients with sustained pain-free status from 2 to 24 hours post-dose(2 to 24 hours post-dose)
- Proportion of patients with headache pain relief at 10 minutes post-dose(10 minutes post-dose)
- Proportion of patients with headache pain relief at 30 minutes post-dose(30 minutes post-dose)
- Proportion of patients who do not use rescue medication within 24 hours post-dose(0 to 24 hours post-dose)
- Proportion of patients returning to normal functional ability at predefined post-dose timepoints(Up to 48 hours post-dose)
- Number of participants with treatment-emergent adverse events(From Screening Visit, through study completion, an average of 16 weeks)