Phase II Trial of PRT-064040 Nasal Spray for the Treatment of Migraine in Adults

Ki vehet részt

• 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

Ki nem vehet részt

• 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 known hypersensitivity to the investigational product or any of its excipients, or history of significant allergic reactions
• Participant with history of migraine with brainstem aura, retinal migraine, or hemiplegic migraine
• 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