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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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Single-center, open label, prospective study conducted at Medstar Georgetown Headache Center. Men and woman ≥ 18 years old that are diagnosed with migraine with or without aura for at least 1 year, who report a reliable migraine trigger. Acceptable triggers for the study will include exercise, alcohol (less than one drink per day for woman and less than two drinks per day for men), air travel that lasts no more than 12 hours, sexual activity, fasting that lasts no more than 24 hours, stress or stress let-down headache.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rimegepant 75 MG | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimegepant 75 MG | Drug | The interventional product is rimegepant ODT 75 mg. Rimegepant 75mg ODT will be given 2 hours prior to a trigger exposure for exercise, alcohol (less than one drink per day for woman and less than two drinks per day for men), air travel that lasts no more than 12 hours, sexual activity, fasting that lasts no more than 24 hours rimegepant will be dosed 2 hours prior to trigger exposure. For weekend or let down headache and changes in sleep pattern, rimegepant will be dosed the night before. The maximum dose in a 24-hour period is 75mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of preemptive treatments with rimegepant in which migraine with a moderate to severe headache intensity | Percentage of preemptive treatments with rimegepant in which migraine with a moderate to severe headache intensity occurs within 24 hours | 24 hour post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of preemptive treatments with rimegepant | Percentage of preemptive treatments with rimegepant in which migraine occurs within 24 hours
| 24 hour, 48 hour post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yemisrach Tadesse | Contact | 3015708508 | yemisrach.g.tadesse@medstar.net |
| Name | Affiliation | Role |
|---|---|---|
| Jessica Ailani, MD | MedStar's Georgetown University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Health: Neurology at McLean | Recruiting | McLean | Virginia | 22101 | United States |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C578443 | rimegepant sulfate |
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| Patient satisfaction with preemptive treatment with rimegepant | Patient satisfaction with preemptive rimegepant treatment will be assessed in the case report form using a Likert scale | At the end of the study completion( 2 month after enrollment) |
| The effect of preemptive treatment with rimegepant on Patient Global Impression of Change (PGIC) | The effect of preemptive treatment with rimegepant on Patient Global Impression of Change (PGIC) using a graded scale of 1-7. | At the end of study completion( 2 months after enrollement) |
| D009422 | Nervous System Diseases |