Migraine
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGeletriptan
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
Sponsors
Pfizer
University of Pittsburgh
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* age 18-45 healthy menstruating female
Exclusion criteria
* cardiac or other conditions precluding use of eletriptan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Headache Index Score Among Patients | baseline to approximately three months | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 71 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | irregular menses | 3 |
| Overall Study | Lost to Follow-up | 7 |
Baseline characteristics
| Characteristic | Eletriptan |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 71 Participants |
| Region of Enrollment United States | 71 participants |
| Sex: Female, Male Female | 71 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 66 |
| serious Total, serious adverse events | 0 / 66 |
Outcome results
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
Time frame: baseline to approximately three months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eletriptan | Change in Mean Headache Index Score Among Patients | -1.52 headache index score | Standard Error 0.05 |