RecruitingMigraine
Phase II Trial of PRT-064040 Nasal Spray for the Treatment of Migraine in Adults
Eligible age
18–75 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Sichuan Purity Pharmaceutical Technology Co., Ltd.
You may qualify if…
- ✓ Key Inclusion Criteria:
- ✓ 1. Male and female participants aged 18-75 years (inclusive);
- ✓ 2. BMI \< 35 kg/m²;
- ✓ 3. 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;
- ✓ 4. Age at first migraine onset \< 50 years;
- ✓ 5. Migraine attacks, on average, lasting about 4-72 hours if untreated or treatment-resistant;
- ✓ 6. 2-8 attacks of moderate to severe intensity per month within the last 3 months；
- ✓ 7. Less than 15 days with headache (migraine or non-migraine) per month within the last 3 months；
You may not qualify if…
- ✕ Key Exclusion Criteria:
- ✕ 1. Participant with history of migraine with brainstem aura, retinal migraine, or hemiplegic migraine.
- ✕ 2. 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.
Source: ClinicalTrials.gov · NCT07304518 · last updated 2026-01-29