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The purpose of this study is to Compare the efficacy of zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet in the acute treatment of migraine.
To develop and evaluate a set of importance weights for a predefined set of treatment attributes for migraine suffers using zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet.
To contrast the efficacy of zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet at early time points.
To analyze the patterns of self-reported tolerability of migraine sufferers using zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet.
An open-label, randomized, cross-over study comparing the efficacy of zolmitriptan 5 mg nasal spray with eletriptan 40 mg tablet at early time points. Satisfaction endpoints include global assessment of preference, overall satisfaction and effectiveness as well as tolerability of both medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zolmitriptan 5 mg nasal spray | Experimental |
| |
| Eletriptan 40 mg Tablet | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zolmitriptan 5 mg Nasal Spray | Drug | Patients will treat 2 migraine attacks with zolmitriptan 5 mg nasal spray and 2 migraine attacks with eletriptan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of migraine headache pain from mild, moderate or severe to pain free. | 30 minutes post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of migraine headache pain from mild, moderate or severe to pain free. | 15 minutes post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David B Kudrow, MD | California Medical Clinic for Headache | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Medical Clinic for Headache | Santa Monica | California | 90404 | United States |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D020773 | Headache Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C089750 | zolmitriptan |
| D059085 | Nasal Sprays |
| C115647 | eletriptan |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D000336 | Aerosols |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 |
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| Eletriptan 40 mg tablet | Drug | Patients will treat 2 migraine attacks with Eletriptan and 2 migraine attacks with zolmitriptan 5 mg nasal spray |
|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Pharmaceutical Preparations |