Phase II Trial of PRT-064040 Nasal Spray for the Treatment of Migraine in Adults
NCT ID: NCT07304518
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
456 participants
INTERVENTIONAL
2026-01-31
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PRT-064040 nasal spray (dose 1)
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.
PRT-064040 nasal spray
A single dose of PRT-064040 nasal spray
PRT-064040 nasal spray (dose 2)
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.
PRT-064040 nasal spray
A single dose of PRT-064040 nasal spray
PRT-064040 nasal spray (dose 3)
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.
PRT-064040 nasal spray
A single dose of PRT-064040 nasal spray
Placebo
Participants administered a single intranasal dose of placebo on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization.
Placebo
A single dose of placebo matched to PRT-064040 nasal spray
Interventions
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PRT-064040 nasal spray
A single dose of PRT-064040 nasal spray
Placebo
A single dose of placebo matched to PRT-064040 nasal spray
Eligibility Criteria
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Inclusion Criteria
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；
8. 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;
9. 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;
10. Able to comprehend and complete study questionnaires with electronic patient-reported outcome (e-PRO) application.
Exclusion Criteria
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.
3. Participant with any nasal structural abnormality, mucosal lesion, or disorder that could interfere with intranasal drug absorption.
4. Participant with dysgeusia, hypogeusia, or related taste disorders.
5. Participant with acute or chronic pain syndromes, or any other pain that in the investigator's opinion could confound study assessments.
6. 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.
7. Clinically relevant abnormal findings in hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, or HIV antibody tests at screening.
8. Participant with history of alcohol or drug abuse within 1 year before screening, or positive urine drug screen at screening.
9. Pregnant or lactating women, or positive pregnancy test at screening.
10. Participant with known hypersensitivity to the investigational product or any of its excipients, or history of significant allergic reactions.
18 Years
75 Years
ALL
No
Sponsors
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Sichuan Purity Pharmaceutical Technology Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Shengyuan Yu
Role: primary
Other Identifiers
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BT-PRT-064-201
Identifier Type: -
Identifier Source: org_study_id