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

Sponsored by:	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

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

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:	106
Study Start Date:	November 2002
Study Completion Date:	December 2003

Arms	Assigned Interventions
A: Experimental	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
ISTANBUL, Turkey
Pfizer Investigational Site
IZMIR, Turkey
Pfizer Investigational Site
SAMSUN, Turkey
Pfizer Investigational Site
GAZIANTEP, Turkey
Turkey, ANKARA
Pfizer Investigational Site
Unknown, ANKARA, Turkey
Turkey, ISTANBUL
Pfizer Investigational Site
CAPA, ISTANBUL, Turkey
Turkey, MANISA
Pfizer Investigational Site
Unknown, MANISA, 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

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1601085
Study First Received:	March 3, 2008
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00634985 History of Changes
Health Authority:	Turkey: Ministry of Health, Central Ethics Committee

Study placed in the following topic categories:

Serotonin Agonists
Eletriptan
Anti-Inflammatory Agents
Neurotransmitter Agents
Central Nervous System Diseases
Headache Disorders, Primary
Brain Diseases
Serotonin

Headache Disorders
Migraine Disorders
Analgesics, Non-Narcotic
Headache
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents

Additional relevant MeSH terms:

Serotonin Agonists
Anti-Inflammatory Agents
Eletriptan
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases
Headache Disorders, Primary
Brain Diseases
Pharmacologic Actions

Headache Disorders
Serotonin Agents
Migraine Disorders
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 07, 2009