Clinical trial NCT00632385: Efficacy and Safety of Eletriptan for the Treatment of Migraine in Patients Not Satisfied With Rizatriptan Therapy
Official title: An Open-label Study of Eletriptan for the Acute Treatment of Migraine in Migraine Sufferers Who Are Dissatisfied With Rizatriptan Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-10
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of eletriptan for migraine headaches in subjects who were not satisfied with rizatriptan therapy


Eligibility criteria: Inclusion Criteria:

* Diagnosis of migraine headache according to International Headache Society criteria and migraine headaches for at least 1 year
* Eletriptan naive
* Previously treated with rizatriptan and failed to achieve a satisfactory response within the past 12 months

Exclusion Criteria:

* Non-migraine headaches on average more than 6 days per month or have less than 24 hours of freedom from headache between migraine attacks
* Migraine attacks that are atypical or chronic daily headaches
* A history of migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migrainous infarction, migraine aura without headache, migraine with acute onset aura

Primary outcomes:
measure: Change from baseline in headache pain severity
timeFrame: 1, 2, 4, and 24 hours
Secondary outcomes:
measure: Functional impairment
timeFrame: 1, 2, 4, and 24 hours
measure: Work Productivity Questionnaire
timeFrame: Week 10
measure: Time Loss
timeFrame: Week 10
measure: Subject Preference Questionnaire
timeFrame: Week 10
measure: Global Evaluation
timeFrame: Week 10
measure: Subject Satisfaction Scale
timeFrame: Week 10
measure: Associated Symptoms
timeFrame: 1, 2, 4, and 24 hours
measure: Use of Rescue Medication
timeFrame: Week 10
measure: Adverse events
timeFrame: Week 10
measure: Vital signs
timeFrame: Week 10
measure: Physical examination
timeFrame: Week 10
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Pfizer Investigational Site
state: California
city: Newport Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Plantation
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Marietta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: South Bend
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Milford
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Chesterfield
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Greensboro
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Alexandria
country: United States
facility: Pfizer Investigational Site
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: