Migraine Disease study: Prasugrel
Official title Migraine Headaches Elimination With Patent Foramen Ovale-Directed Therapy
ClinicalTrials.gov ID: NCT07629635
What this study is testing
What is Prasugrel 5mg?
This is an investigational daily pill being studied to see if it helps reduce migraines in people with a specific heart opening. It is designed to stop blood platelets from sticking together to form clots.
Also referred to as Prasugrel Hydrochloride.
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 study wants to see if closing a PFO gives lasting migraine relief after stopping prasugrel, especially in people whose migraines improved while on the drug.
- Who it's for
- Adults who have migraines and a patent foramen ovale, and whose migraines got better while taking prasugrel.
- What's involved
- Participants will keep a daily migraine diary, take prasugrel for 24 weeks, and those whose migraines improve will be randomly assigned to either keep taking prasugrel or to have a minimally invasive procedure to close the PFO while continuing prasugrel. After 24 weeks, the drug is stopped and migraines are tracked for about 8 weeks.
- Time commitment
- The study lasts about 32 weeks total, with daily migraine tracking, 24 weeks of medication, and a follow‑up period of roughly 8 weeks after stopping the drug.
- Phase 3: a large, late-stage study
- Time commitment: about 8 weeks
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 55
You may be able to join if
- Patient
- Age: ≥18 and \<55 at time of screening
- Migraine headache with aura, or migraine headache without aura, fulfilling conditions of the Neurology Screening Tool (meeting ICHD-3 criteria)
- Diagnosis of migraine for ≥ 1 year; onset of migraine symptoms \< 40 years of age
- without current preventative therapy, OR
You likely can't join if
- Headache disorder other than migraine with aura, or migraine without aura
- Patient has history of stroke, TIA, or intracranial hemorrhage.
- Patient has a history of thrombocytopenia within one year, or platelet count \<100,000/mm3 identified during the screening laboratory evaluation.
- Patient has severe hepatic impairment with reduced synthetic function as documented by prolongation of PT/PTT, or with total bilirubin \>3.0 mg/dL...
- Patient has previously implanted pacemaker, IVC filter, PFO closure device, ASD closure device, or left atrial appendage closure device or any...
- Patient has documented right-to-left shunt source in addition to PFO such as atrial septal defect or pulmonary arteriovenous malformation.
See the full eligibility criteria
- Patient
- Age: ≥18 and \<55 at time of screening
- Migraine headache with aura, or migraine headache without aura, fulfilling conditions of the Neurology Screening Tool (meeting ICHD-3 criteria)
- Diagnosis of migraine for ≥ 1 year; onset of migraine symptoms \< 40 years of age
- without current preventative therapy, OR
- despite preventative therapy, OR
- with reason to come off effective therapy (e.g. cost, aversion to injections, side effects)
- If patient is taking preventive migraine medications, dose must be stable for at least 3 months prior to the screening visit.
- Female patients capable of becoming pregnant agree to use two forms of birth control or abstinence during their participation in the study. Patient
- Headache disorder other than migraine with aura, or migraine without aura
- Patient has history of stroke, TIA, or intracranial hemorrhage.
- Patient has a history of thrombocytopenia within one year, or platelet count \<100,000/mm3 identified during the screening laboratory evaluation.
- Patient has severe hepatic impairment with reduced synthetic function as documented by prolongation of PT/PTT, or with total bilirubin \>3.0 mg/dL identified during the screening laboratory evaluation.
- Patient has previously implanted pacemaker, IVC filter, PFO closure device, ASD closure device, or left atrial appendage closure device or any cardiac history which, in the investigator's opinion, would preclude them...
- Patient has documented right-to-left shunt source in addition to PFO such as atrial septal defect or pulmonary arteriovenous malformation.
- Patient has a history of clinically significant bleeding within 6 months of the screening visit, any active bleeding, or active peptic ulcer disease.
- Patient has an uncontrolled arrhythmia, or if on therapy, has evidence of arrhythmia control failure within the past 90 days (e.g., supraventricular tachycardia or atrial fibrillation while under rhythm control).
- Patient has elevated PVR which in the opinion of the implanting physician precludes safe PFO closure.
- Patient has active infection at the time of screening that cannot be treated.
- Patient is planning surgery during the study timeframe.
- A female patient is pregnant or is planning pregnancy during the anticipated duration of the study. Urine or blood pregnancy screening will be performed as part of the screening laboratory evaluation.
- Patient has documented nickel allergy/sensitivity
- Patient has known hypersensitivity or contraindication to thienopyridines
- Patient has another medical condition requiring chronic antithrombotic therapy with antiplatelet, oral anticoagulant or injectable agents
- Patient has need for daily use of NSAIDs other than for treatment of migraines
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
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, but confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.