NCT07304518招募中2 期
Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase II Trial of PRT-064040 Nasal Spray for the Acute Treatment of Migraine
Sichuan Purity Pharmaceutical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 456 人开始时间: 2026年1月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 456
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Freedom From Pain at 2 Hours Post-dose
研究概览
简要总结
The purpose of this study is to learn about the efficacy and safety of PRT-064040 Nasal Spray versus placebo in the acute treatment of moderate or severe migraine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 participants aged 18-75 years (inclusive);
- •BMI < 35 kg/m²;
- •Participant has at least 1-year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition;
- •Age at first migraine onset < 50 years;
- •Migraine attacks, on average, lasting about 4-72 hours if untreated or treatment-resistant;
- •2-8 attacks of moderate to severe intensity per month within the last 3 months；
- •Less than 15 days with headache (migraine or non-migraine) per month within the last 3 months；
- •Participants on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to screening visit and the dose is not expected to change until the EOT visit;
- •Patients diagnosed with chronic migraine who, owing to stable preventive therapy, have < 15 headache days and 2-8 attacks of moderate to severe intensity per month in the 3 months before screening, and who meet all other entry criteria, may be enrolled;
- •Able to comprehend and complete study questionnaires with electronic patient-reported outcome (e-PRO) application.
排除标准
- •Participant with history of migraine with brainstem aura, retinal migraine, or hemiplegic migraine.
- •Participant with evidence of poorly controlled, unstable, or recently diagnosed cardiovascular or cardiometabolic disease, or prior history thereof, including:
- •Ischemic heart disease, coronary vasospasm, or cerebral ischemia diagnosed within 6 months before screening;
- •Previous stroke, transient ischemic attack, myocardial infarction, acute coronary syndrome, cardiac surgery, or percutaneous coronary intervention;
- •Abnormal 12-lead ECG at screening;
- •Poorly controlled diabetes mellitus or hypertension;
- •Poorly controlled or severe peripheral vascular disease.
- •Participant with any nasal structural abnormality, mucosal lesion, or disorder that could interfere with intranasal drug absorption.
- •Participant with dysgeusia, hypogeusia, or related taste disorders.
- •Participant with acute or chronic pain syndromes, or any other pain that in the investigator's opinion could confound study assessments.
- •Participant with history of regular use of ergotamine or triptans ≥ 10 days per month for ≥ 3 months; or regular use of non-narcotic analgesics (e.g., acetaminophen, NSAIDs, gabapentin) ≥ 15 days per month for ≥ 3 months.
- •Clinically relevant abnormal findings in hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, or HIV antibody tests at screening.
- •Participant with history of alcohol or drug abuse within 1 year before screening, or positive urine drug screen at screening.
- •Pregnant or lactating women, or positive pregnancy test at screening.
- •Participant with known hypersensitivity to the investigational product or any of its excipients, or history of significant allergic reactions.
研究组 & 干预措施
PRT-064040 nasal spray (dose 1)
Experimental
Participants administered a single intranasal dose of PRT-064040 nasal spray (dose 1) on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization.
干预措施: PRT-064040 nasal spray (Drug)
PRT-064040 nasal spray (dose 2)
Experimental
Participants administered a single intranasal dose of PRT-064040 nasal spray (dose 2) on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization.
干预措施: PRT-064040 nasal spray (Drug)
PRT-064040 nasal spray (dose 3)
Experimental
Participants administered a single intranasal dose of PRT-064040 nasal spray (dose 3) on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization.
干预措施: PRT-064040 nasal spray (Drug)
Placebo
Experimental
Participants administered a single intranasal dose of placebo on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Freedom From Pain at 2 Hours Post-dose
时间窗: 2 hours post-dose
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose
时间窗: 2 hours post-dose
次要结局
- Percentage of Participants With Pain Relief at 15 Minutes Post-dose(15 minutes post-dose)
- Percentage of Participants With Pain Relief at 30 Minutes Post-dose(30 minutes post-dose)
- Percentage of Participants With Pain Relief at 60 Minutes Post-dose(60 minutes post-dose)
- Percentage of Participants With Pain Relief at 2 Hours Post-dose(2 hours post-dose)
- Percentage of Participants Who Were Able to Function Normally at 2 Hours Post-dose(2 hours post-dose)
- Percentage of Participants With Sustained Pain Relief From 2 Hours to 24 Post-dose(From 2 to 24 hours post-dose)
- Percentage of Participants With Sustained Pain Relief From 2 Hours to 48 Post-dose(From 2 to 48 hours post-dose)
- Percentage of Participants Who Were Able to Function Normally at 30 Minutes Post-dose(30 minutes post-dose)
- Percentage of Participants Who Were Able to Function Normally at 60 Minutes Post-dose(60 minutes post-dose)
- Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose(2 hours post-dose)
- Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose(2 hours post-dose)
- Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose(2 hours post-dose)
- Percentage of Participants With Sustained Pain Freedom From 2 Hours to 24 Post-dose(From 2 to 24 hours post-dose)
- Percentage of Participants With Sustained Pain Freedom From 2 Hours to 48 Post-dose(From 2 to 48 hours post-dose)
- Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose(From 2 hours to 48 hours post-dose)
- Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose(Through 24 hours post-dose)
- Percentage of Participants Who Were Able to Function Normally at 15 Minutes Post-dose(15 minutes post-dose)
- The incidence and severity of adverse events(Through 7(±2) days post-dose)
研究者
研究点 (1)
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