PRT-064040 nasal spray for acute migraine in adults

Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase II Trial of PRT-064040 Nasal Spray for the Acute Treatment of Migraine

This will test whether a nasal spray called PRT-064040 can relieve moderate to severe migraine attacks in adults.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 456 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Purity Pharmaceutical Technology Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07304518 on ClinicalTrials.gov

What this trial studies

This is a Phase 2 interventional study comparing PRT-064040 nasal spray with placebo for the acute treatment of moderate to severe migraine in adults. Eligible participants are 18 to 75 years old with at least a one-year history of migraine and typically 2–8 attacks of moderate to severe intensity per month and fewer than 15 headache days per month. Participants will use the assigned nasal spray to treat qualifying migraine attacks and will be followed for measures of symptom relief and safety. The study will collect data on how well the drug relieves pain and associated symptoms and on any adverse events.

Who should consider this trial

Good fit: Adults aged 18–75 with a diagnosis of migraine for at least one year who experience about 2–8 moderate to severe migraine attacks per month and fewer than 15 headache days per month are the intended participants.

Not a fit: People with more than 15 headache days per month, migraine onset after age 50, BMI ≥35 kg/m², or who cannot attend the study site visits are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this could offer a fast-acting, non-oral option for treating acute migraine attacks.

How similar studies have performed: Other intranasal migraine medications (for example, intranasal triptans and dihydroergotamine) have shown benefit, so nasal delivery is a validated approach, but PRT-064040 itself is still being tested in controlled trials.

Eligibility criteria

Inclusion Criteria:

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；
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:

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.
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.

Where this trial is running

Beijing, Beijing Municipality

• The First Medical Center of PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Ke Yao

Conditions Migraine