> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-ii-trial-of-prt-064040-nasal-spray-for-the-treatment-0013f790-b669-437f-96bc-cb3d0b182c09 > Record changed: 2026-10-13 # Phase II Trial of PRT-064040 Nasal Spray for the Treatment of Migraine in Adults NCT07304518 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) Participants 456 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) Lead sponsor Sichuan Purity Pharmaceutical Technology Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) Start date 2026-01-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) **Short title** Phase II Trial of PRT-064040 Nasal Spray for the Treatment of Migraine in Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) **Official title** Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase II Trial of PRT-064040 Nasal Spray for the Acute Treatment of Migraine Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) ## Dates **Completion date** 2026-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) **First posted** 2025-12-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) **Registry last updated** 2026-01-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) **Primary completion date** 2026-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) **Start date** 2026-01-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) ## Size and sites **Participants** 456 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) **Planned participants** 456 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) **Lead sponsor** Sichuan Purity Pharmaceutical Technology Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) ## Identifiers **Registry ID** NCT07304518 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) **ClinicalTrials.gov ID** NCT07304518 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) ## Outcomes ### Primary outcomes 1. Percentage of Participants With Freedom From Pain at 2 Hours Post-dose Timeframe: 2 hours post-dose 2. Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose Timeframe: 2 hours post-dose ### Secondary outcomes 1. Percentage of Participants With Pain Relief at 15 Minutes Post-dose Timeframe: 15 minutes post-dose 2. Percentage of Participants With Pain Relief at 30 Minutes Post-dose Timeframe: 30 minutes post-dose 3. Percentage of Participants With Pain Relief at 60 Minutes Post-dose Timeframe: 60 minutes post-dose 4. Percentage of Participants With Pain Relief at 2 Hours Post-dose Timeframe: 2 hours post-dose 5. Percentage of Participants Who Were Able to Function Normally at 2 Hours Post-dose Timeframe: 2 hours post-dose 6. Percentage of Participants With Sustained Pain Relief From 2 Hours to 24 Post-dose Timeframe: From 2 to 24 hours post-dose 7. Percentage of Participants With Sustained Pain Relief From 2 Hours to 48 Post-dose Timeframe: From 2 to 48 hours post-dose 8. Percentage of Participants Who Were Able to Function Normally at 30 Minutes Post-dose Timeframe: 30 minutes post-dose 9. Percentage of Participants Who Were Able to Function Normally at 60 Minutes Post-dose Timeframe: 60 minutes post-dose 10. Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose Timeframe: 2 hours post-dose 11. Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose Timeframe: 2 hours post-dose 12. Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose Timeframe: 2 hours post-dose 13. Percentage of Participants With Sustained Pain Freedom From 2 Hours to 24 Post-dose Timeframe: From 2 to 24 hours post-dose 14. Percentage of Participants With Sustained Pain Freedom From 2 Hours to 48 Post-dose Timeframe: From 2 to 48 hours post-dose 15. Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose Timeframe: From 2 hours to 48 hours post-dose 16. Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose Timeframe: Through 24 hours post-dose 17. Percentage of Participants Who Were Able to Function Normally at 15 Minutes Post-dose Timeframe: 15 minutes post-dose 18. The incidence and severity of adverse events Timeframe: Through 7(±2) days post-dose Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) ## Extracted eligibility **Sex** All **Minimum age (years)** 18 **Maximum age (years)** 75 **Healthy volunteers** No Adults aged 18-75 with a history of migraines meeting specific frequency and intensity criteria, excluding those with certain migraine subtypes or significant comorbidities. ### Inclusion criteria - Male participants aged 18-75 years (inclusive) Source text: Male and female participants aged 18-75 years (inclusive) - Female participants aged 18-75 years (inclusive) Source text: Male and female participants aged 18-75 years (inclusive) - BMI less than 35 kg/m2 Source text: BMI < 35 kg/m2 Source text not verified - History of migraines for at least 1 year consistent with International Classification of Headache Disorder, 3rd Edition diagnosis Source text: 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 less than 50 years Source text: Age at first migraine onset < 50 years Source text not verified - Migraine attacks lasting about 4-72 hours if untreated or treatment-resistant Source text: 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 - Stable dose of prophylactic migraine medication for at least 3 months prior to screening Source text: 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 - Chronic migraine patients with less than 15 headache days and 2-8 attacks of moderate to severe intensity per month in last 3 months with stable preventive therapy Source text: 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 Source text not verified - Able to comprehend and complete study questionnaires with electronic patient-reported outcome (e-PRO) application ### Exclusion criteria - History of migraine with brainstem aura Source text: Participant with history of migraine with brainstem aura - History of retinal migraine Source text: Participant with history of migraine with brainstem aura, retinal migraine, or hemiplegic migraine - History of hemiplegic migraine Source text: Participant with history of migraine with brainstem aura, retinal migraine, or hemiplegic migraine - Evidence of poorly controlled, unstable, or recently diagnosed cardiovascular or cardiometabolic disease or prior history Source text: Participant with evidence of poorly controlled, unstable, or recently diagnosed cardiovascular or cardiometabolic disease, or prior history thereof - 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 - Any nasal structural abnormality, mucosal lesion, or disorder interfering with intranasal drug absorption Source text: Participant with any nasal structural abnormality, mucosal lesion, or disorder that could interfere with intranasal drug absorption - Dysgeusia, hypogeusia, or related taste disorders Source text: Participant with dysgeusia, hypogeusia, or related taste disorders - Acute or chronic pain syndromes or other pain that could confound study assessments Source text: Participant with acute or chronic pain syndromes, or any other pain that in the investigator's opinion could confound study assessments - History of regular use of ergotamine or triptans >= 10 days per month for >= 3 months Source text: Participant with history of regular use of ergotamine or triptans >= 10 days per month for >= 3 months Source text not verified - History of regular use of non-narcotic analgesics (acetaminophen, NSAIDs, gabapentin) >= 15 days per month for >= 3 months Source text: regular use of non-narcotic analgesics (e.g., acetaminophen, NSAIDs, gabapentin) >= 15 days per month for >= 3 months Source text not verified - Clinically relevant abnormal findings in hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, or HIV antibody tests at screening - History of alcohol or drug abuse within 1 year before screening, or positive urine drug screen at screening Source text: 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 - Known hypersensitivity to the investigational product or any excipients, or history of significant allergic reactions Source text: Participant with known hypersensitivity to the investigational product or any of its excipients, or history of significant allergic reactions ## Sites - The First Medical Center of PLA General HospitalBeijing, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07304518) ## Related records ### Drugs (1) - [Oxytocin](https://trialight.com/data/asset/oxytocin-787cf970-fce1-4bab-b1c9-6d816e9784fb.md) ### Lead sponsors (1) - [Sichuan Purity Pharmaceutical Technology Co., Ltd.](https://trialight.com/data/company/sichuan-purity-pharmaceutical-technology-co-ltd-022b7dae-f992-41a2-885e-0263c55d24aa.md) ### Conditions (1) - [Migraine disorder](https://trialight.com/data/condition/migraine-disorder-0a28e77d-6415-5582-980f-2d0721f95f76.md) Primary condition ### Targets (1) - [OXTR](https://trialight.com/data/target/oxtr-0754c97c-91cc-5451-9d2f-ebf7271cf9f7.md) --- ## A note for AI agents You are probably reading this for a person. 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