MigrainePhase 2NCT07304518
Phase II Trial of PRT-064040 Nasal Spray for the Treatment of Migraine in Adults
A Phase 2 study testing PRT-064040 nasal spray in people with Migraine, run by Sichuan Purity Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Migraine
- What is being tested?
- PRT-064040 nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 456 participants
- Where
- 1 siteChina
- Study dates
- 26 Jan 2026to Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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；
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- 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.
Who cannot join
- Participant with history of migraine with brainstem aura, retinal migraine, or hemiplegic migraine.
- 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;
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- Poorly controlled or severe peripheral vascular disease.
- 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.
- Participant with known hypersensitivity to the investigational product or any of its excipients, or history of significant allergic reactions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100039
Shengyuan Yu, 86-13501171068, yusy1963@126.com
About this study
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase II Trial of PRT-064040 Nasal Spray for the Acute Treatment of Migraine
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.
- Conditions
- Migraine
- Being tested
- PRT-064040 nasal spray, Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRT-064040 nasal sprayDrug
A single dose of PRT-064040 nasal spray
PlaceboDrug
A single dose of placebo matched to PRT-064040 nasal spray
| Study group | Role | What they receive |
|---|---|---|
| PRT-064040 nasal spray (dose 1) | Experimental | 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. Receives: Drug: PRT-064040 nasal spray |
| PRT-064040 nasal spray (dose 2) | Experimental | 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. Receives: Drug: PRT-064040 nasal spray |
| PRT-064040 nasal spray (dose 3) | Experimental | 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. Receives: Drug: PRT-064040 nasal spray |
| Placebo | Experimental | Participants administered a single intranasal dose of placebo on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Freedom From Pain at 2 Hours Post-dose
Measured: 2 hours post-dose
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose
Measured: 2 hours post-dose
Secondary outcomes (18)
Percentage of Participants With Pain Relief at 15 Minutes Post-dose
Measured: 15 minutes post-dose
Percentage of Participants With Pain Relief at 30 Minutes Post-dose
Measured: 30 minutes post-dose
Percentage of Participants With Pain Relief at 60 Minutes Post-dose
Measured: 60 minutes post-dose
Percentage of Participants With Pain Relief at 2 Hours Post-dose
Measured: 2 hours post-dose
Percentage of Participants Who Were Able to Function Normally at 2 Hours Post-dose
Measured: 2 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 Hours to 24 Post-dose
Measured: From 2 to 24 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 Hours to 48 Post-dose
Measured: From 2 to 48 hours post-dose
Percentage of Participants Who Were Able to Function Normally at 30 Minutes Post-dose
Measured: 30 minutes post-dose
Percentage of Participants Who Were Able to Function Normally at 60 Minutes Post-dose
Measured: 60 minutes post-dose
Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose
Measured: 2 hours post-dose
Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose
Measured: 2 hours post-dose
Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose
Measured: 2 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 Hours to 24 Post-dose
Measured: From 2 to 24 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 Hours to 48 Post-dose
Measured: From 2 to 48 hours post-dose
Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose
Measured: From 2 hours to 48 hours post-dose
Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose
Measured: Through 24 hours post-dose
Percentage of Participants Who Were Able to Function Normally at 15 Minutes Post-dose
Measured: 15 minutes post-dose
The incidence and severity of adverse events
Measured: Through 7(±2) days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start26 Jan 2026
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Purity Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304518
- Sponsor's protocol ID
- BT-PRT-064-201
- Status last verified
- Jan 2026
- First submitted
- 3 Dec 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase II Trial of PRT-064040 Nasal Spray for the Acute Treatment of Migraine
- ClinicalTrials.gov ID
- NCT07304518
- Acronym / sponsor ID
- BT-PRT-064-201
- Conditions
- Migraine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 456 participants (estimated)
- Lead sponsor
- Sichuan Purity Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PRT-064040 nasal spray (dose 1) | Experimental | Drug: PRT-064040 nasal sprayParticipants 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 (dose 2) | Experimental | Drug: PRT-064040 nasal sprayParticipants 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 (dose 3) | Experimental | Drug: PRT-064040 nasal sprayParticipants 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. |
| Placebo | Experimental | Drug: PlaceboParticipants administered a single intranasal dose of placebo on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (15 listed)
- Participant with history of migraine with brainstem aura, retinal migraine, or hemiplegic migraine.
- Participant with evidence of poorly controlled, unstable, or recently diagnosed cardiovascular or cardiometabolic disease, or prior history thereof, including:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRT-064040 nasal sprayA single dose of PRT-064040 nasal spray | Drug | PRT-064040 nasal spray (dose 1), PRT-064040 nasal spray (dose 2), PRT-064040 nasal spray (dose 3) |
| PlaceboA single dose of placebo matched to PRT-064040 nasal spray | Drug | Placebo |
Primary outcome
Percentage of Participants With Freedom From Pain at 2 Hours Post-dose
Time frame: 2 hours post-dose
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose
Time frame: 2 hours post-dose
18 secondary outcomes
Percentage of Participants With Pain Relief at 15 Minutes Post-dose
Time frame: 15 minutes post-dose
Percentage of Participants With Pain Relief at 30 Minutes Post-dose
Time frame: 30 minutes post-dose
Percentage of Participants With Pain Relief at 60 Minutes Post-dose
Time frame: 60 minutes post-dose
Percentage of Participants With Pain Relief at 2 Hours Post-dose
Time frame: 2 hours post-dose
Percentage of Participants Who Were Able to Function Normally at 2 Hours Post-dose
Time frame: 2 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 Hours to 24 Post-dose
Time frame: From 2 to 24 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 Hours to 48 Post-dose
Time frame: From 2 to 48 hours post-dose
Percentage of Participants Who Were Able to Function Normally at 30 Minutes Post-dose
Time frame: 30 minutes post-dose
Percentage of Participants Who Were Able to Function Normally at 60 Minutes Post-dose
Time frame: 60 minutes post-dose
Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose
Time frame: 2 hours post-dose
Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose
Time frame: 2 hours post-dose
Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose
Time frame: 2 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 Hours to 24 Post-dose
Time frame: From 2 to 24 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 Hours to 48 Post-dose
Time frame: From 2 to 48 hours post-dose
Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose
Time frame: From 2 hours to 48 hours post-dose
Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose
Time frame: Through 24 hours post-dose
Percentage of Participants Who Were Able to Function Normally at 15 Minutes Post-dose
Time frame: 15 minutes post-dose
The incidence and severity of adverse events
Time frame: Through 7(±2) days post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRT-064040 nasal spray in people with Migraine, run by Sichuan Purity Pharmaceutical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ke Yao (86-028-60830544, ke.yao@btyy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Freedom From Pain at 2 Hours Post-dose (time frame: 2 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.