Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a double-blinded placebo study, examining the efficacy of Sumatriptan with Naprosyn in the treatment of migraine with aura.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo taken at onset of aura associated with migraine. |
|
| 2 | Active Comparator | Sumatriptan with naprosyn taken at onset of aura associated with migraine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sumatriptan with naprosyn | Drug | Subjects will be randomized before treatment. Subjects will take one sumatriptan 85mg/naprosyn 500mg tablets (Treximet) or placebo at onset of a migraine aura. Dose to be repeated at 2 hours if no effect in preventing onset of migraine pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome measure will be comparative percentage of patients pain free at 2 and 4 hours from initiating treatment with placebo vs treatment with Treximet (sumatriptan with naprosyn). | 2 and 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcomes will be percentage of patients with pain relief at 2 and 4 hours. | 2 and 4 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary K Betz, MS | Contact | 716-250-2000 | mbetz@dentinstitute.com | |
| Rebecca Hogan, BS | Contact | 716-558-5670 | rhogan@dentinstitute.com |
| Name | Affiliation | Role |
|---|---|---|
| Laszlo L Mechtler, MD | Dent Neurologic Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dent Neurologic Institute | Recruiting | Amherst | New York | 14226 | United States |
Not provided
| ID | Term |
|---|---|
| D020325 | Migraine with Aura |
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D018170 | Sumatriptan |
| D009288 | Naproxen |
| C000611385 | sumatriptan-naproxen |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| placebo | Drug | Subjects will be randomized before treatment. Subjects will take one sumatriptan 85mg/naprosyn 500mg tablets (Treximet) or placebo at onset of a migraine aura. Dose to be repeated at 2 hours if no effect in preventing onset of migraine pain. |
|
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |