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New treatment option for Migraine
Official title Phase II Trial of PRT-064040 Nasal Spray for the Treatment of Migraine in Adults
ClinicalTrials.gov ID: NCT07304518
What this study is testing
What is PRT-064040 nasal spray?
PRT-064040 nasal spray is an investigational medicine, being studied as a potential treatment for migraine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Age at first migraine onset \< 50 years;
- Migraine attacks, on average, lasting about 4-72 hours if untreated or treatment-resistant;
You likely can't join if
- Key Exclusion Criteria:
- 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...
- 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;
See the full eligibility criteria
- 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；
- 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...
- 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...
- Able to comprehend and complete study questionnaires with electronic patient-reported outcome (e-PRO) application.
- Key Exclusion Criteria:
- 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;
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.