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New nasal spray aims to zap migraines fast

NCT ID NCT07304518

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tests whether a single dose of PRT-064040 nasal spray can quickly relieve moderate to severe migraine pain and the most bothersome symptoms. About 456 adults with a history of migraines will receive either the spray or a placebo. The main goal is to see if more people are pain-free and symptom-free two hours after using the spray.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PRT-064040 nasal spray
What this could lead to
If it works, this could provide a fast-acting, non-pill option to stop migraine pain and bothersome symptoms within hours.
What could go wrong
This is an early Phase 2 trial with 456 people, so results may not apply to everyone. The spray might not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 456 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Medical Center of PLA General Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100039, China

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