Safety and Efficacy of Eletriptan for the Treatment of Migraine in Subjects Unsuccessfully Treated With Nonsteroidal Anti-inflammatory Drugs - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00634985

Purpose

To assess the safety and efficacy of eletriptan for the treatment of migraine in subjects who had not been adequately treated with non-steroidal antiinflammatory drugs (NSAIDs)

Condition	Intervention	Phase
Migraine	Drug: eletriptan	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multicentre, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Eletriptan 40 Mg for the Treatment of Migraine (With or Without Aura) in Subjects Unsuccessfully Treated With NSAIDS

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine Nausea and Vomiting

Drug Information available for: Eletriptan Eletriptan Hydrobromide

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Headache severity and response post-treatment [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Functional response post-treatment [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Presence of associated symptoms including, nausea, vomiting, phonophobia, and photophobia at baseline and post-treatment [ Time Frame: 1, 2, 4, and 24 hours ] [ Designated as safety issue: No ]
Migraine recurrence post-treatment [ Time Frame: 1, 2, 4, and 24 hours ] [ Designated as safety issue: No ]
Time loss (from normal activities and from work) post-treatment [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Subject preference and acceptability post-treatment [ Time Frame: 24 hours and 12 weeks ] [ Designated as safety issue: No ]
Subject satisfaction post-treatment [ Time Frame: 2 and 24 hours ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
Physical examination [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
Electrocardiogram [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
Headache severity and response at baseline and post-treatment [ Time Frame: 1, 4 and 24 hours ] [ Designated as safety issue: No ]
Functional impairment severity and response at baseline and post-treatment [ Time Frame: 1, 4 and 24 hours ] [ Designated as safety issue: No ]

Enrollment:	120
Study Start Date:	November 2002
Study Completion Date:	December 2003

Arms	Assigned Interventions
Experimental: A	Drug: eletriptan 40 mg oral tablet for migraine attack; additional 40 mg oral tablet >2 hours from first dose if migraine reoccurred within 24 hours of achieving response

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Met International Headache Society diagnostic criteria for migraine with or without aura
Expected to suffer one to six acute migraine attacks per month based on past history
Experienced migraines for at least one year prior to entering study, and historically have not responded to NSAIDs

Exclusion Criteria:

Frequent migraine or frequent concomitant non-migrainous headache (average of >6 attacks per month)
Atypical migraines that consistently failed to respond to adequate medical therapy
Migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migrainous infarction, migraine aura without headache, or migraine with acute-onset aura

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634985

Locations

Turkey
Pfizer Investigational Site
Unknown, Ankara, Turkey
Pfizer Investigational Site
Capa, Istanbul, Turkey
Pfizer Investigational Site
Unknown, Manisa, Turkey
Pfizer Investigational Site
Gaziantep, Turkey
Pfizer Investigational Site
Istanbul, Turkey
Pfizer Investigational Site
Izmir, Turkey
Pfizer Investigational Site
Samsun, Turkey

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier:	NCT00634985 History of Changes
Other Study ID Numbers:	A1601085
Study First Received:	March 3, 2008
Last Updated:	April 22, 2011
Health Authority:	Turkey: Ministry of Health, Central Ethics Committee

Additional relevant MeSH terms:

Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Eletriptan
Therapeutic Uses
Pharmacologic Actions

Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012