Phase II Trial of PRT-064040 Nasal Spray for the Treatment of Migraine in Adults

NCT07304518
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
456
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Lead sponsor
Sichuan Purity Pharmaceutical Technology Co., Ltd.
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Start date
2026-01-26
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Number of sites
1
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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.
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Short title
Phase II Trial of PRT-064040 Nasal Spray for the Treatment of Migraine in Adults
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Official title
Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase II Trial of PRT-064040 Nasal Spray for the Acute Treatment of Migraine
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2026-10-01
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First posted
2025-12-26
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Registry last updated
2026-01-29
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Primary completion date
2026-09-01
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Start date
2026-01-26
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Participants
456
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Participant count basis
Estimated
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Planned participants
456
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Protocol amendments
0
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Sichuan Purity Pharmaceutical Technology Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07304518
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ClinicalTrials.gov ID
NCT07304518
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

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.

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
clinicaltrials.gov

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.

  • 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

  • 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

  • The First Medical Center of PLA General HospitalBeijing, ChinaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)