Trial Outcomes & Findings for Prospective Survey of Menstrual Migraine & Prevention With Eletriptan (NCT NCT00259649)

NCT ID: NCT00259649

Last Updated: 2011-07-04

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 71 participants
• Primary outcome timeframe: baseline to approximately three months
• Results posted on: 2011-07-04

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	71
Overall Study COMPLETED	61
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Measure	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
Overall Study Lost to Follow-up	7
Overall Study irregular menses	3

Baseline Characteristics

Prospective Survey of Menstrual Migraine & Prevention With Eletriptan

Baseline characteristics by cohort

Measure	Eletriptan n=71 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	71 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	71 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Eletriptan n=71 Participants 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
Change in Mean Headache Index Score Among Patients	-1.52 headache index score Standard Error 0.05

Adverse Events

Eletriptan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dawn marcus

University of Pittsburgh

Phone: 412-953-4797

Email: marcusd@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place