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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
Women are followed prospectively for 3 months, recording headaches, other symptoms, and menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan for 3 months.
Women are followed prospectively for 3 months, recording headaches, other symptoms, and menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan for 3 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eletriptan | Drug | oral eletriptan 20 mg three times a day beginning 2 days before the expected onset of menstrual flow and continued for a total of 6 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Headache Index Score Among Patients | Headache index is an average headache severity score recorded using a 0-10 severity scale recorded 4 times daily. Scores are averaged to produce an average severity score which can range between 0 (no headaches) to 10 (always a maximum severity headache). Change in headache activity was evaluated by comparing mean severity scores during the 3 months pre-intervention are compared with 3 months of preventive therapy | baseline to approximately three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn Marcus, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15206 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eletriptan | Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Eletriptan | Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mean Headache Index Score Among Patients | Headache index is an average headache severity score recorded using a 0-10 severity scale recorded 4 times daily. Scores are averaged to produce an average severity score which can range between 0 (no headaches) to 10 (always a maximum severity headache). Change in headache activity was evaluated by comparing mean severity scores during the 3 months pre-intervention are compared with 3 months of preventive therapy | Posted | Apr 2010 | Mean | Standard Error | headache index score | baseline to approximately three months |
|
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71 participants were enrolled in the study. Five did not receive treatment or attend their initial follow-up assessment. Therefore, AE data were only available for 66 participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eletriptan | Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months |
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Relatively small sample size and open-label treatment limit Menstrual regulation by hormonal therapy might have affected treatment response;
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawn marcus | University of Pittsburgh | 412-953-4797 | marcusd@upmc.edu |
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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 |
|---|---|
| C115647 | eletriptan |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
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| 0 |
| 66 |
| 0 |
| 66 |
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| D009422 | Nervous System Diseases |